Neurocrine Biosciences Inc (NBIX)

Neurocrine Biosciences Initiates Phase 2 Study of Crinecerfont in Pediatric Patients Under 4 Years Old with Classic Congenital Adrenal HyperplasiaJuly 1, 2026 4:05 PM
PR Newswire (US) SAN DIEGO, July 1, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of its Phase 2 clinical study to assess the safety and tolerability of crinecerfont in children aged 3 months to under 4 years with classic congenital adrenal hyperplasia (CAH). Crinecerfont, marketed as CRENESSITY®, is approved in the United States as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients 4 years of age and older with classic CAH. "Infants and young children with classic CAH face significant health challenges and are often exposed to high doses of glucocorticoids during critical periods of growth and development," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "The initiation of this Phase 2 study reflects our commitment to evaluating crinecerfont as a potential treatment option that could reduce the need for long-term supraphysiologic glucocorticoid use and help mitigate the associated risks in this vulnerable, very young population."CAH is typically identified at or shortly after birth and can lead to life-threatening adrenal crises due to the underlying adrenal insufficiency, as well as androgen excess and consistent dosing of supraphysiologic glucocorticoids – complications for which there are no approved therapies in children under 4 years of age. Neurocrine is conducting this pediatric study under an FDA Pediatric Written Request.The Phase 2 open-label, single-arm study consists of a 24-week treatment period with a primary objective of assessing the safety and tolerability of crinecerfont in 20 participants aged 3 months to under 4 years with classic CAH. Secondary objectives include evaluation of the pharmacokinetics and pharmacodynamic effects of crinecerfont on hormone biomarkers. This study is expected to support a planned supplemental New Drug Application to expand the approved U.S. indication to include patients less than 4 years of age. Additional information about the trial, including eligibility criteria, can be found at ClinicalTrials.gov.Separately, Neurocrine achieved target enrollment for a Phase 2 study in the European Union to evaluate the safety and tolerability of crinecerfont in children from birth to under 2 years of age with classic CAH. For more information, visit ClinicalTrials.gov.Crinecerfont was approved by the U.S. Food and Drug Administration in 2024, marking the first therapeutic advancement in more than 70 years for patients with classic CAH. It is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist that reduces elevated adrenocorticotropic hormone (ACTH) secretion at the source and the resulting downstream excess adrenal androgens through a non-GC mechanism.About Congenital Adrenal Hyperplasia
Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal steroid hormones, such as cortisol, aldosterone and adrenal androgens. Severe enzyme deficiency leads to an inability of the adrenal glands to produce enough cortisol and, in approximately 75% of cases, aldosterone. Because individuals with CAH are typically still able to produce androgens, the unused precursors that would normally be used to make cortisol instead result in the production of excess amounts of androgens. If left untreated, CAH can result in adrenal crisis and even death.Exogenous glucocorticoids (GCs) are necessary to correct the endogenous cortisol deficiency, but historically, doses higher than those needed for cortisol replacement (supraphysiologic) have been used to lower the elevated levels of adrenocorticotropic hormone (ACTH) and adrenal androgens. However, GC treatment at supraphysiologic doses has been associated with serious and significant complications of steroid excess, including metabolic issues such as weight gain and diabetes, cardiovascular disease and osteoporosis. Additionally, long-term treatment with supraphysiologic GCs may have psychological and cognitive impacts, such as changes in mood and memory. Adrenal androgen excess has been associated with abnormal bone growth and development in pediatric patients, female health problems such as excess facial hair growth and menstrual irregularities, in addition to cardiometabolic and fertility issues in both sexes. The symptoms of high ACTH may include testicular adrenal rest tumors (TARTs).About CRENESSITY® (crinecerfont)
CRENESSITY is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist that reduces and controls excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a non-glucocorticoid (GC) mechanism for the treatment of classic congenital adrenal hyperplasia (CAH). Antagonism of CRF1 receptors in the pituitary has been shown to decrease ACTH levels, which in turn decreases the production of adrenal androgens and potentially the symptoms associated with CAH. The robust clinical study data demonstrate that lowering adrenal androgen levels with CRENESSITY enables lower, more physiologic dosing of GCs to replace missing cortisol.CRENESSITY comes in capsules and an oral solution. For adults 18 years of age and older, the recommended dosage is 100 mg twice daily taken orally with a meal. For pediatric patients 4 to 17 years of age weighing less than 55 kg (121 lbs), the recommended dosage is based on body weight and is administered twice daily, taken orally with a meal. For pediatric patients weighing more than 55 kg (121 lbs), the recommended dosage is 100 mg twice daily taken orally with a meal. Healthcare providers can work with patients to determine the appropriate formulation for use depending on patient needs. Patients receiving CRENESSITY should continue GC therapy for cortisol replacement.Important InformationApproved Uses
CRENESSITY® (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH).IMPORTANT SAFETY INFORMATIONDo not take CRENESSITY if you:Are allergic to crinecerfont, or any of the ingredients in CRENESSITY.CRENESSITY may cause serious side effects, including:Allergic reactions. Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY.Risk of Sudden Adrenal Insufficiency or Adrenal Crisis with Too Little Glucocorticoid (Steroid) Medicine. Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk for sudden adrenal insufficiency or adrenal crisis. Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine.Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.The most common side effects of CRENESSITY in adults include tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain.The most common side effects of CRENESSITY in children include headache, stomach pain, tiredness, nasal congestion, and nosebleeds.These are not all the possible side effects of CRENESSITY. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.Dosage Forms and Strengths: CRENESSITY is available in 50 mg and 100 mg capsules, and as an oral solution of 50 mg/mL.Please see full Prescribing Information.About Neurocrine Biosciences, Inc. 
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, YOU DESERVE BRAVE SCIENCE and CRENESSITY are registered trademarks of Neurocrine Biosciences, Inc.Forward-Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding our future development plans with respect to crinecerfont; the efficacy and therapeutic potential of crinecerfont in children aged 3 months to under 4 years with classic congenital adrenal hyperplasia (CAH); and the value and benefits CRENESSITY brings to adults and pediatric patients 4 years of age and older with CAH. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.© 2026 Neurocrine Biosciences, Inc. All Rights Reserved. View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-initiates-phase-2-study-of-crinecerfont-in-pediatric-patients-under-4-years-old-with-classic-congenital-adrenal-hyperplasia-302816226.htmlSOURCE Neurocrine Biosciences, Inc. Original: Neurocrine Biosciences Initiates Phase 2 Study of Crinecerfont in Pediatric Patients Under 4 Years Old with Classic Congenital Adrenal Hyperplasia

Neurocrine Biosciences Presents First Retrospective Case Series of CRENESSITY® (crinecerfont) in Patients with Classic Congenital Adrenal Hyperplasia Due to 11ß-Hydroxylase Deficiency at ENDO 2026June 15, 2026 4:05 PM
PR Newswire (US) Androstenedione and other adrenal hormone levels in 11ß-hydroxylase-deficient patients improved substantially after initiation of CRENESSITY, with >90% median reductions in 11-deoxycortisol and 11-deoxycorticosteroneNearly all patients (14/15) reduced their total glucocorticoid dose with CRENESSITY, and 2 of 5 patients on antihypertensive medications reduced or discontinued these drugsFindings provide initial clinical insights in patients with classic congenital adrenal hyperplasia due to 11ß-hydroxylase deficiency, a rare subtype not previously studied in clinical trials of CRENESSITYSAN DIEGO, June 15, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced clinical findings from the first retrospective case series in pediatric and adult patients with classic congenital adrenal hyperplasia (CAH) due to 11ß-hydroxylase deficiency. This subtype was not previously studied in clinical trials of CRENESSITY® (crinecerfont) and is the second most common form of classic CAH after 21-hydroxylase deficiency, accounting for approximately 5% of cases. The findings were presented at the Endocrine Society's annual meeting, ENDO 2026, in Chicago. Like other forms of CAH, 11ß-hydroxylase deficiency (11ß-OHD) is characterized by cortisol deficiency and excess adrenal androgens. However, 11ß-OHD is uniquely associated with the accumulation of the adrenal steroid precursors 11-deoxycortisol (11-dF) and 11-deoxycorticosterone (DOC). These hormonal imbalances can contribute to distinct clinical features, including hypertension and other long-term complications. In this retrospective case series, reductions in androstenedione (A4) were observed across all patients with elevated baseline levels following initiation of CRENESSITY. Steroid precursors also decreased, with values reaching within normal ranges, and blood pressure improved in adult patients."Patients with 11ß-hydroxylase deficiency represent a complex subgroup within classic congenital adrenal hyperplasia, with limited data available to guide treatment decisions for these individuals," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "This first case series provides preliminary clinical insights on the use of CRENESSITY to target ACTH and potentially improve hormonal control in patients with 11ß-hydroxylase deficiency, highlighting our ongoing commitment to advancing care for the entire classic CAH community."This retrospective case series outlines clinical responses to CRENESSITY treatment in 15 pediatric (n=11) and adult (n=4) patients with classic CAH due to 11ß-OHD. Across all patients with elevated A4 and/or adrenal steroid precursors at baseline, initiation of CRENESSITY was associated with reduction of levels.A4 and precursor normalization were observed as early as one month following treatment initiation, including in patients whose hormone excess had persisted despite prior supraphysiologic glucocorticoid (GC) therapy.Among patients with elevated hormones at baseline, median decreases of -92% (DOC, n=5), -95% (11-dF, n=7), and -65% (A4, n=3) were observed after CRENESSITY initiation.Among patients receiving antihypertensive treatment, two of five were able to reduce or discontinue these medications.Following the initiation of CRENESSITY, 14 of 15 patients were able to reduce their total GC dose."Patients with 11ß-hydroxylase deficiency often experience both androgen excess and elevated adrenal steroid precursors that can contribute to hypertension and other complications, making disease management particularly challenging," said Kyriakie Sarafoglou, M.D., Professor, Department of Pediatrics and Department of Experimental and Clinical Pharmacology, Divisions of Endocrinology and Genetics & Metabolism, University of Minnesota. "Given the rarity of this condition, data from 15 patients gives clinicians meaningful insight into the potential role of CRENESSITY in managing this challenging form of classic congenital adrenal hyperplasia."This case series provides early, foundational evidence supporting the efficacy and safety of CRENESSITY treatment in patients with classic CAH due to 11ß-OHD. Although CRENESSITY is approved as an adjunctive treatment to GCs for patients with classic CAH regardless of enzyme deficiency, there is limited evidence on its use in this rare subtype. These findings support further exploration of CRENESSITY in this classic CAH subtype and reinforce Neurocrine's commitment to supporting patients across the full spectrum of classic CAH and other rare endocrine diseases.Presentations at the ENDO 2026 annual meeting included: CAHtalyst® Adult Study Two-Year ResultsTitle: Weight-Related Outcomes and Insulin Resistance in Adults with Classic Congenital Adrenal Hyperplasia: 2-Year Results from the CAHtalyst Adult Study (Oral Presentation #ORF32-07)
Authors: Oksana Hamidi, D.O., et alTitle: Adults with Classic Congenital Adrenal Hyperplasia Taking Crinecerfont Demonstrated Sustained Decreases in Glucocorticoid Doses: 2-Year Results from the CAHtalyst Adult Study (Poster Presentation #SUN-458)
Authors: Irina Bancos, M.D., et alTitle: A Cross-sectional Survey on Quality of Life of Adults with Classic Congenital Adrenal Hyperplasia in the United States Participating in CAHtalyst Adult Open-Label Extension Study (Poster Presentation #SUN-467)
Authors: Sonal Vaid, M.D., et alTitle: Bone Outcomes in Adults with Classic Congenital Adrenal Hyperplasia Treated with Crinecerfont for Up to 2 Years in CAHtalyst Adult Study (Poster Presentation #SUN-468)
Authors: Maria Vogiatzi, M.D., et alCAHtalyst Pediatric Study Two-Year ResultsTitle: Characterization of Children and Adolescents with Classic Congenital Adrenal Hyperplasia Who Had Slowed Bone Age Progression and Improved Height Prediction with Crinecerfont (Oral Presentation #ORF32-05)
Authors: Maria Vogiatzi, M.D., et alTitle: Long-term Crinecerfont Treatment Reduced ACTH and 17-Hydroxyprogesterone — Clinical Outcomes in Children and Adolescents with Classic Congenital Adrenal Hyperplasia: 2-Year Results from CAHtalyst Pediatric (Poster Presentation #SAT-465)
Authors: Natalie Nokoff, M.D., et alTitle: Long-term Crinecerfont Enables Sustained Decreases in Glucocorticoid Doses — Clinical Outcomes in Children and Adolescents with Classic Congenital Adrenal Hyperplasia: 2-Year Results from CAHtalyst Pediatric (Poster Presentation #SUN-465)
Authors: Kyriakie Sarafoglou, M.D., et alAdditional PresentationsTitle: Long-Term Risk of Cardiometabolic Comorbidities Associated with Glucocorticoid Exposure and Androgen Control in Classic Congenital Adrenal Hyperplasia: A Cox Proportional Hazards Analysis from the CAHtalog Registry ("New Therapies and Perspectives for Congenital Adrenal Hyperplasia and Adrenal Insufficiency" Rapid Fire Presentation #ORF32-02 and Poster Presentation #MON-495)
Authors: Oksana Lekarev, D.O., et alTitle: Crinecerfont Treatment of Classic Congenital Adrenal Hyperplasia Due to 11ß-Hydroxylase Deficiency: A Case Series (Poster Presentation #SAT-466)
Authors: Kyriakie Sarafoglou, M.D., et al Title: A Modified Delphi Panel of U.S. Endocrinologists to Align on Minimum Clinically Important Difference in Glucocorticoid Dose and Other Key Considerations in Classic Congenital Adrenal Hyperplasia (Poster Presentation #SAT-459)
Authors: Ahmed Khattab, M.D., et alAbout Congenital Adrenal Hyperplasia 
Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal steroid hormones, such as cortisol, aldosterone and adrenal androgens. Severe enzyme deficiency leads to an inability of the adrenal glands to produce enough cortisol and, in approximately 75% of cases, aldosterone. Because individuals with CAH are typically still able to produce androgens, the unused precursors that would normally be used to make cortisol instead result in the production of excess amounts of androgens. If left untreated, CAH can result in adrenal crisis and even death. Exogenous glucocorticoids (GCs) are necessary to correct the endogenous cortisol deficiency, but historically, doses higher than those needed for cortisol replacement (supraphysiologic) have been used to lower the elevated levels of adrenocorticotropic hormone (ACTH) and adrenal androgens. However, GC treatment at supraphysiologic doses has been associated with serious and significant complications of steroid excess, including metabolic issues such as weight gain and diabetes, cardiovascular disease and osteoporosis. Additionally, long-term treatment with supraphysiologic GCs may have psychological and cognitive impacts, such as changes in mood and memory. Adrenal androgen excess has been associated with abnormal bone growth and development in pediatric patients, female health problems such as excess facial hair growth and menstrual irregularities, in addition to cardiometabolic and fertility issues in both sexes. The symptoms of high ACTH may include testicular adrenal rest tumors (TARTs). About CRENESSITY® (crinecerfont)
CRENESSITY is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist that reduces and controls excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a non-glucocorticoid (GC) mechanism for the treatment of classic congenital adrenal hyperplasia (CAH). Antagonism of CRF1 receptors in the pituitary has been shown to decrease ACTH levels, which in turn decreases the production of adrenal androgens and potentially the symptoms associated with CAH. The robust clinical study data demonstrate that lowering adrenal androgen levels with CRENESSITY enables lower, more physiologic dosing of GCs to replace missing cortisol. CRENESSITY comes in capsules and an oral solution. For adults 18 years?of age?and older, the recommended dosage is 100 mg twice daily taken orally with a meal. For pediatric patients four to 17 years of age weighing less than 55 kg (121?lbs), the recommended dosage is based on body weight and is administered twice daily, taken orally with a meal. For pediatric patients weighing more than 55 kg (121?lbs), the recommended dosage is?100 mg?twice daily taken orally with a meal. Healthcare providers can work with patients to?determine?the?appropriate formulation?for use depending on patient needs. Patients receiving CRENESSITY should continue GC therapy for cortisol replacement.About the CAHtalyst® Studies
The Phase 3 CAHtalyst global registrational studies were designed to evaluate the safety, efficacy and tolerability of CRENESSITY® (crinecerfont) in children and adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The CAHtalyst studies were the largest-ever clinical trial program in classic CAH, including 285 pediatric and adult patients.The?CAHtalyst?Pediatric study included 103 pediatric?patients?four to 17 years?of age. The study tested two questions. The first question evaluated whether four weeks of CRENESSITY treatment could improve androgen control. The second question evaluated whether an additional?24 weeks?of CRENESSITY treatment enabled customized glucocorticoid (GC) down-titration while androstenedione levels were?maintained?or improved. The?CAHtalyst?Adult?study?included 182 adult patients 18 to 58 years?of age. Similarly, the first question of the study evaluated whether four weeks of CRENESSITY treatment could improve androgen control, and the second question evaluated whether an?additional?20 weeks?of CRENESSITY treatment enabled GC reduction to?physiologic?range while androstenedione levels were?maintained?or improved.Data from the?CAHtalyst?Phase 3 studies supported approval of CRENESSITY by the?U.S.?Food and Drug Administration?in?December 2024. The?open-label extension treatment portions of both studies are ongoing.Important InformationApproved Uses
CRENESSITY® (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH).IMPORTANT SAFETY INFORMATIONDo not take CRENESSITY if you:Are allergic to?crinecerfont, or any of the ingredients in CRENESSITY.CRENESSITY may cause serious side effects, including: Allergic?reactions.?Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY.Risk of Sudden Adrenal Insufficiency or Adrenal Crisis?with?Too Little Glucocorticoid (Steroid) Medicine.?Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk?for?sudden adrenal insufficiency or adrenal crisis. Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine.Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions, including if you:?are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.Tell your healthcare provider about all the medicines you take,?including prescription and over-the-counter medicines, vitamins and herbal supplements.The most common side effects of CRENESSITY in adults include?tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain.The most common side effects of CRENESSITY in children include?headache, stomach pain, tiredness, nasal congestion, and nosebleeds.These are not all the possible?side effects of CRENESSITY. Call your healthcare provider for medical advice?about?side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch?at?www.fda.gov/medwatch?or call 1-800-FDA-1088.Dosage Forms and Strengths:?CRENESSITY is available in 50 mg and?100 mg?capsules,?and as an oral solution of?50 mg/mL.Please see full?Prescribing Information.About Neurocrine Biosciences, Inc.
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, CRENESSITY and CAHtalyst are registered trademarks of Neurocrine Biosciences, Inc.Forward-Looking Statements 
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from CRENESSITY for the treatment of classic congenital adrenal hyperplasia (CAH); the value and benefits CRENESSITY brings to patients with CAH, including its potential to target adrenocorticotropic hormone (ACTH) and improve hormonal control in patients with CAH due to 11ß-hydroxylase deficiency; the ability of Neurocrine Biosciences to ensure patients have access to CRENESSITY; and whether the results from our clinical trials of CRENESSITY are indicative of real-world results. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of CRENESSITY; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of CRENESSITY, including the extent to which patients and physicians accept and adopt CRENESSITY; whether CRENESSITY receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; risks associated with the Company's dependence on third parties for development and manufacturing activities related to CRENESSITY, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for CRENESSITY may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding CRENESSITY; risks that post-approval CRENESSITY commitments or requirements may be delayed; risks that CRENESSITY may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.© 2026 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-CFT-US-0062 06/2026 View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-first-retrospective-case-series-of-crenessity-crinecerfont-in-patients-with-classic-congenital-adrenal-hyperplasia-due-to-11hydroxylase-deficiency-at-endo-2026-302799772.htmlSOURCE Neurocrine Biosciences, Inc. Original: Neurocrine Biosciences Presents First Retrospective Case Series of CRENESSITY® (crinecerfont) in Patients with Classic Congenital Adrenal Hyperplasia Due to 11ß-Hydroxylase Deficiency at ENDO 2026

Soleno Therapeutics Presents New VYKAT® XR (diazoxide choline) Data at ENDO 2026 Demonstrating Meaningful and Durable Improvements in Hyperphagia and Behavioral Symptoms in Prader-Willi Syndrome Following Randomized Withdrawal PeriodJune 15, 2026 4:10 PM
PR Newswire (US) Participants who resumed VYKAT XR following a 16-week randomized withdrawal period demonstrated improvements in hyperphagia and behavioral symptoms as early as Week 13, with benefits continuing through 2 yearsVYKAT XR demonstrated statistically significant and sustained improvements in hyperphagia and Prader-Willi syndrome-related behaviors for up to 3 years compared to real-world data from the PATH for PWS Natural History StudySAN DIEGO, June 15, 2026 /PRNewswire/ -- Soleno Therapeutics, a Neurocrine Biosciences (Nasdaq: NBIX) company, today announced late-breaking data at ENDO 2026 showing that resuming treatment with VYKAT® XR (diazoxide choline) extended-release tablets for two years after a 16-week randomized withdrawal period was associated with durable improvements in hyperphagia and behavioral symptoms characteristic of Prader-Willi syndrome (PWS).   "These compelling data further reinforce our confidence in VYKAT XR as a safe and effective long-term treatment for hyperphagia in individuals four years of age and older living with Prader-Willi syndrome," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "Individuals who resumed treatment following the randomized withdrawal period achieved durable improvements in hyperphagia and other PWS-related behaviors. This completes the presentation of data from our comprehensive Phase 3 development program and further confirms the long-term benefit of VYKAT XR for people living with PWS."The VYKAT XR Phase 3 development program was conducted sequentially, including:A 13-week randomized, double-blind, parallel-arm study (C601) comparing VYKAT XR to placebo in participants four years of age and older with hyperphagia associated with genetically confirmed PWSAn open-label extension study (C602 OLE) over approximately two to four yearsA 16-week, double-blind, placebo-controlled randomized withdrawal periodAn open-label long-term extension study (C614)  Study C614, the open-label long-term extension study, enrolled 77 participants (mean age, 15.3 years; 55.8% female). The study assessed whether participants who had received placebo during the randomized withdrawal period could regain treatment benefit after restarting VYKAT XR, and whether participants who remained on continuous VYKAT XR maintained benefit over time.Hyperphagia was assessed using the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) and PWS-related behaviors were assessed using the PWS Profile questionnaire (PWSP). BMI and long-term safety were also assessed. Study results included:Participants who restarted VYKAT XR after placebo during the randomized withdrawal showed marked improvements in HQ-CT Total Score by Week 13 (mean [SD], -4.5 [6.3]), with further improvement observed at Week 26 and at two years (-5.5 [7.1] and -6.3 [8.4], respectively).Participants who remained on VYKAT XR continuously showed smaller improvements (-2.7 [6.9]) at Week 13 that were sustained at Week 26 and at two years (-3.3 [5.7] and -3.1 [8.0], respectively), underscoring the benefit of uninterrupted therapy.Improvements across all six PWSP behavioral domains were observed at two years in participants who restarted VYKAT XR, and BMI remained relatively stable throughout.These data show that participants who resumed VYKAT XR after randomized withdrawal experienced recovery of treatment benefit, while those who continued therapy maintained durable improvements in hyperphagia and other PWS-related behaviors. Study results were presented as, "Efficacy and Safety of Resuming Diazoxide Choline Extended-Release (DCCR) after 16-week Randomized Withdrawal in Prader-Willi Syndrome (Study C614)," which was authored by Jennifer L. Miller, M.D., University of Florida, Gainesville.Additional presentations at ENDO 2026: VYKAT XR Outcomes Compared to Real-World Data from PATH for PWS Natural History Study (PATH):Long-Term Reductions in Hyperphagia: HQ-CT Analysis
A poster presentation led by Evelien F. Gevers, M.D., Ph.D., Barts Health NHS Trust/Queen Mary University of London, reported three-year data comparing 125 VYKAT XR-treated participants from Studies C601 and C602-OLE to 229 natural history controls from the PATH for PWS Natural History Study. VYKAT XR demonstrated statistically significant and sustained improvements in hyperphagia compared with the PATH cohort at all evaluated time points (p

Neurocrine Biosciences Presents New Two-Year CRENESSITY® (crinecerfont) Data Demonstrating Improvements in Cardiometabolic Outcomes in Adults with Classic Congenital Adrenal Hyperplasia at ENDO 2026June 15, 2026 8:30 AM
PR Newswire (US) Two-year CRENESSITY data in adults showed improvements in cardiometabolic outcomes of insulin resistance, body composition and body weight alongside sustained reductions in glucocorticoid doseAmong participants who were overweight or obese at baseline, 37% achieved >5% reduction in body weight at 2 years, and 43% of those with insulin resistance at baseline were no longer insulin resistant at 2 yearsFavorable trends in bone health outcomes were observed with CRENESSITY treatment, including improvements in bone mineral density with up to 2 years of treatmentPatient-reported survey data from adults in the open-label extension suggested improvements in quality of life outcomes and treatment satisfaction, including emotional well-being, energy levels and confidence in managing their classic congenital adrenal hyperplasia with CRENESSITYSAN DIEGO, June 15, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new Phase 3 CAHtalyst® Adult study data demonstrating improved cardiometabolic outcomes alongside sustained glucocorticoid dose reduction through up to two years of treatment with CRENESSITY® (crinecerfont) for classic congenital adrenal hyperplasia. These results, together with additional presentations highlighting improvement in bone outcomes and patient-reported quality of life survey outcomes, were presented at the Endocrine Society's annual meeting, ENDO 2026, in Chicago. Long-term supraphysiologic glucocorticoid (GC) treatment in adults with classic congenital adrenal hyperplasia (CAH) is associated with obesity, insulin resistance, increased cardiometabolic risk and adverse effects on bone health. In these analyses, adults with classic CAH taking CRENESSITY for up to two years experienced improvements in weight, body composition and insulin resistance, key markers of long-term health, with sustained GC dose reductions and maintenance of baseline androgen control."These two-year results provide important evidence on the long-term impact of CRENESSITY for adults living with classic congenital adrenal hyperplasia," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "Sustained improvements across key clinical outcomes, including both cardiometabolic and bone outcomes, underscore the potential of CRENESSITY to meaningfully redefine lifelong disease management and improve health. We are excited to share these new data with the scientific community as we continue to deepen our understanding of the long-term impact of CRENESSITY on patient outcomes and quality of life."CAHtalyst adult participants (N=182) who completed the 24-week, double-blind, placebo-controlled period and the subsequent six-month, open-label period of the study continued treatment with CRENESSITY in an ongoing open-label extension.Sustained Improvements in Weight-related and Metabolic Outcomes over Two YearsCardiometabolic clinical outcomes were evaluated through up to two years of CRENESSITY treatment, including changes in body weight, body mass index (BMI), body composition and insulin resistance, as assessed by the homeostatic model assessment for insulin resistance (HOMA-IR) at Months 12 and 24. To avoid potential confounding from glucagon-like peptide-1 (GLP-1) receptor agonists and/or glucose-dependent insulinotropic polypeptide (GIP) use, data from participants taking these medications (n=9) were excluded from the time the medication was started.Sustained improvements were observed, with mean reductions from baseline in body weight, BMI and insulin resistance.Among participants who were overweight or obese at baseline, more than one-third achieved clinically meaningful weight loss (>5%) at two years, with reductions in fat mass exceeding changes in lean mass.Improvements in insulin resistance were also sustained through two years, including among participants with insulin resistance at baseline, 43% of whom were no longer insulin resistant at two years.MeasureBaselineChange
from
Baseline at
Month 12Change from
Baseline at
Month 24Mean daily GC dose (mg/m²/day HCe*)17.6-6.8(-37%)-7.0(-38%)Mean BMI (kg/m2)†‡32.5-0.9-0.9Percentage of overweight/obese participants who
achieved >5% reduction in weight†‡—31%(35/114)37%(35/95)Change in percent fat mass versus percent lean
mass†‡—-0.9%
versus
+0.7%-0.9%
versus
+0.8%Mean HOMA-IRठ5.3-1.5-1.7Percentage of participants who achieved
HOMA-IR ≤2.5‡§—40%(26/65)43%(24/56)*HCe denotes hydrocortisone equivalents. 
†Among participants who were overweight or obese (BMI ≥25 kg/m2) at baseline. Clinically meaningful weight loss is defined as >5% reduction in body weight.
‡Data from participants who were taking a GIP/GLP-1 receptor agonist were excluded from the time the medication was started.
§Among participants with insulin resistance (HOMA-IR >2.5) at baseline."For many adults with classic congenital adrenal hyperplasia, long-term supraphysiologic glucocorticoid exposure can contribute to weight gain and insulin resistance, adding to cumulative cardiometabolic burden over time," said Oksana Hamidi, D.O., M.S.C.S., Associate Professor of Internal Medicine, Division of Endocrinology, UT Southwestern Medical Center. "What makes these two-year data particularly meaningful is that they demonstrate sustained glucocorticoid reductions alongside improvements in insulin resistance and body composition, outcomes that are closely tied to future cardiometabolic risk and long-term health."Favorable Trends Observed Across Bone-related OutcomesBone-related outcomes were also assessed over two years of CRENESSITY treatment, including bone mineral density (BMD) z scores at Months 12, 18 and 24, and mean changes from baseline in bone turnover markers at Months 12 and 18.Favorable trends were observed in mineral density measurements (lumbar spine and total hip) and bone turnover (formation/resorption).BMD z scores trended toward incremental improvement over time, with the greatest improvement in the lumbar spine where there is the largest proportion of GC-sensitive bone.All bone turnover markers increased from baseline to Month 12, potentially reflecting recovery from suppression caused by supraphysiologic GC doses.From Month 12 to Month 18, markers of bone formation remained at similar levels, while markers of bone resorption showed a decreasing trend.Patient-reported Survey Data Reflect Meaningful Changes in Lived ExperienceTo understand patient perspectives following long-term CRENESSITY treatment, a cross-sectional survey was conducted among adult U.S. participants (n=48) at their final open-label extension visit.In the survey, 96% of respondents indicated they were moderately or very satisfied with their experience with CRENESSITY treatment, and a majority of participants reported:Having more hope for their future living with classic CAH (98%).Feeling more in control of their classic CAH (94%).Being more optimistic about reducing the long-term impacts of high-dose GCs (96%) and elevated adrenocorticotropic hormone or androgens (92%).Large majorities of participants who experienced improvements also reported those changes as meaningful, including less side effects associated with high-dose steroids (93%) and less worry about weight gain associated with high-dose steroids (81%), as well as high levels of treatment satisfaction, with 98% reporting they would recommend CRENESSITY and 96% reporting they preferred treatment with CRENESSITY over treatment without CRENESSITY.Across analyses, CRENESSITY was generally well tolerated through up to two years of treatment, with no new safety signals observed during long-term follow-up.These findings build on two-year data presented earlier this year at the American Association of Clinical Endocrinology 2026 Annual Meeting and the Pediatric Endocrine Society 2026 Annual Meeting in adults and pediatrics, respectively.Presentations at the ENDO 2026 annual meeting included: CAHtalyst Adult Study Two-Year ResultsTitle: Weight-Related Outcomes and Insulin Resistance in Adults with Classic Congenital Adrenal Hyperplasia: 2-Year Results from the CAHtalyst Adult Study (Oral Presentation #ORF32-07)
Authors: Oksana Hamidi, D.O., et alTitle: Adults with Classic Congenital Adrenal Hyperplasia Taking Crinecerfont Demonstrated Sustained Decreases in Glucocorticoid Doses: 2-Year Results from the CAHtalyst Adult Study (Poster Presentation #SUN-458)
Authors: Irina Bancos, M.D., et alTitle: A Cross-sectional Survey on Quality of Life of Adults with Classic Congenital Adrenal Hyperplasia in the United States Participating in CAHtalyst Adult Open-Label Extension Study (Poster Presentation #SUN-467)
Authors: Sonal Vaid, M.D., et alTitle: Bone Outcomes in Adults with Classic Congenital Adrenal Hyperplasia Treated with Crinecerfont for Up to 2 Years in CAHtalyst Adult Study (Poster Presentation #SUN-468)
Authors: Maria Vogiatzi, M.D., et alCAHtalyst Pediatric Study Two-Year ResultsTitle: Characterization of Children and Adolescents with Classic Congenital Adrenal Hyperplasia Who Had Slowed Bone Age Progression and Improved Height Prediction with Crinecerfont (Oral Presentation #ORF32-05)
Authors: Maria Vogiatzi, M.D., et alTitle: Long-term Crinecerfont Treatment Reduced ACTH and 17-Hydroxyprogesterone — Clinical Outcomes in Children and Adolescents with Classic Congenital Adrenal Hyperplasia: 2-Year Results from CAHtalyst Pediatric (Poster Presentation #SAT-465)
Authors: Natalie Nokoff, M.D., et alTitle: Long-term Crinecerfont Enables Sustained Decreases in Glucocorticoid Doses — Clinical Outcomes in Children and Adolescents with Classic Congenital Adrenal Hyperplasia: 2-Year Results from CAHtalyst Pediatric (Poster Presentation #SUN-465)
Authors: Kyriakie Sarafoglou, M.D., et alAdditional PresentationsTitle: Long-term Risk of Cardiometabolic Comorbidities Associated with Glucocorticoid Exposure and Androgen Control in Classic Congenital Adrenal Hyperplasia: A Cox Proportional Hazards Analysis from the CAHtalog Registry ("New Therapies and Perspectives for Congenital Adrenal Hyperplasia and Adrenal Insufficiency" Rapid Fire Presentation #ORF32-02 and Poster Presentation #MON-495)
Authors: Oksana Lekarev, D.O., et alTitle: Crinecerfont Treatment of Classic Congenital Adrenal Hyperplasia Due to 11ß-Hydroxylase Deficiency: A Case Series (Poster Presentation #SAT-466)
Authors: Kyriakie Sarafoglou, M.D., et alTitle: A Modified Delphi Panel of U.S. Endocrinologists to Align on Minimum Clinically Important Difference in Glucocorticoid Dose and Other Key Considerations in Classic Congenital Adrenal Hyperplasia (Poster Presentation #SAT-459)
Authors: Ahmed Khattab, M.D., et alAbout Congenital Adrenal Hyperplasia 
Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal steroid hormones, such as cortisol, aldosterone and adrenal androgens. Severe enzyme deficiency leads to an inability of the adrenal glands to produce enough cortisol and, in approximately 75% of cases, aldosterone. Because individuals with CAH are typically still able to produce androgens, the unused precursors that would normally be used to make cortisol instead result in the production of excess amounts of androgens. If left untreated, CAH can result in adrenal crisis and even death.Exogenous glucocorticoids (GCs) are necessary to correct the endogenous cortisol deficiency, but historically, doses higher than those needed for cortisol replacement (supraphysiologic) have been used to lower the elevated levels of adrenocorticotropic hormone (ACTH) and adrenal androgens. However, GC treatment at supraphysiologic doses has been associated with serious and significant complications of steroid excess, including metabolic issues such as weight gain and diabetes, cardiovascular disease and osteoporosis. Additionally, long-term treatment with supraphysiologic GCs may have psychological and cognitive impacts, such as changes in mood and memory. Adrenal androgen excess has been associated with abnormal bone growth and development in pediatric patients, female health problems such as excess facial hair growth and menstrual irregularities, in addition to cardiometabolic and fertility issues in both sexes. The symptoms of high ACTH may include testicular adrenal rest tumors (TARTs). About CRENESSITY® (crinecerfont)
CRENESSITY is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist that reduces and controls excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a non-glucocorticoid (GC) mechanism for the treatment of classic congenital adrenal hyperplasia (CAH). Antagonism of CRF1 receptors in the pituitary has been shown to decrease ACTH levels, which in turn decreases the production of adrenal androgens and potentially the symptoms associated with CAH. The robust clinical study data demonstrate that lowering adrenal androgen levels with CRENESSITY enables lower, more physiologic dosing of GCs to replace missing cortisol.CRENESSITY comes in capsules and an oral solution. For adults 18 years?of age?and older, the recommended dosage is 100 mg twice daily taken orally with a meal. For pediatric patients four to 17 years of age weighing less than 55 kg (121?lbs), the recommended dosage is based on body weight and is administered twice daily, taken orally with a meal. For pediatric patients weighing more than 55 kg (121?lbs), the recommended dosage is?100 mg?twice daily taken orally with a meal. Healthcare providers can work with patients to?determine?the?appropriate formulation?for use depending on patient needs. Patients receiving CRENESSITY should continue GC therapy for cortisol replacement.?About the CAHtalyst® Studies
The Phase 3?CAHtalyst?global registrational studies were designed to evaluate the safety, efficacy and tolerability of CRENESSITY® (crinecerfont)?in children and adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The?CAHtalyst?studies were the largest-ever clinical trial program in classic CAH, including 285 pediatric and adult patients.The? CAHtalyst Pediatric study included 103 pediatric?patients?four to 17 years?of age. The study tested two questions. The first question evaluated whether four weeks of CRENESSITY treatment could improve androgen control. The second question evaluated whether an additional?24 weeks?of CRENESSITY treatment enabled customized glucocorticoid (GC) down-titration while androstenedione levels were?maintained?or improved.The?CAHtalyst Adult study included 182 adult patients 18 to 58 years?of age. Similarly, the first question of the study evaluated whether four weeks of CRENESSITY treatment could improve androgen control, and the second question evaluated whether an?additional?20 weeks?of CRENESSITY treatment enabled GC reduction to?physiologic?range while androstenedione levels were?maintained?or improved.Data from the?CAHtalyst?Phase 3 studies supported approval of CRENESSITY by the?U.S.?Food and Drug Administration?in?December 2024. The?open-label extension treatment portions of both studies are ongoing.Important InformationApproved Uses
CRENESSITY® (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH).?IMPORTANT SAFETY INFORMATIONDo not take CRENESSITY if you:?Are allergic to?crinecerfont, or any of the ingredients in CRENESSITY.CRENESSITY may cause serious side effects, including:Allergic?reactions.?Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY.?Risk of Sudden Adrenal Insufficiency or Adrenal Crisis?with?Too Little Glucocorticoid (Steroid) Medicine.?Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk?for?sudden adrenal insufficiency or adrenal crisis. Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine.?Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions, including if you:?are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.Tell your healthcare provider about all the medicines you take,?including prescription and over-the-counter medicines, vitamins and herbal supplements.The most common side effects of CRENESSITY in adults include?tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain.The most common side effects of CRENESSITY in children include?headache, stomach pain, tiredness, nasal congestion, and nosebleeds.These are not all the possible?side effects of CRENESSITY. Call your healthcare provider for medical advice?about?side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch?at?www.fda.gov/medwatch?or call 1-800-FDA-1088.Dosage Forms and Strengths:?CRENESSITY is available in 50 mg and?100 mg?capsules,?and as an oral solution of?50 mg/mL.Please see full?Prescribing Information.About Neurocrine Biosciences, Inc. 
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, CRENESSITY and CAHtalyst are registered trademarks of Neurocrine Biosciences, Inc.Forward-Looking Statements 
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from CRENESSITY for the treatment of classic congenital adrenal hyperplasia (CAH); the value and benefits CRENESSITY brings to patients with CAH, including its potential support sustained glucocorticoid dose reductions and contribute to improvements in certain cardiometabolic, bone health and patient-reported outcomes; the ability of Neurocrine Biosciences to ensure patients have access to CRENESSITY; and whether the results from our clinical trials of CRENESSITY are indicative of real-world results. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of CRENESSITY; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of CRENESSITY, including the extent to which patients and physicians accept and adopt CRENESSITY; whether CRENESSITY receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; risks associated with the Company's dependence on third parties for development and manufacturing activities related to CRENESSITY, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for CRENESSITY may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding CRENESSITY; risks that post-approval CRENESSITY commitments or requirements may be delayed; risks that CRENESSITY may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.© 2026 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-CFT-US-0063 06/2026 View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-new-two-year-crenessity-crinecerfont-data-demonstrating-improvements-in-cardiometabolic-outcomes-in-adults-with-classic-congenital-adrenal-hyperplasia-at-endo-2026-302799744.htmlSOURCE Neurocrine Biosciences, Inc. Original: Neurocrine Biosciences Presents New Two-Year CRENESSITY® (crinecerfont) Data Demonstrating Improvements in Cardiometabolic Outcomes in Adults with Classic Congenital Adrenal Hyperplasia at ENDO 2026

Neurocrine Biosciences Presents New Two-Year CRENESSITY® (crinecerfont) Data Demonstrating Improved Growth Measures in Pediatric Patients with Classic Congenital Adrenal Hyperplasia at ENDO 2026June 15, 2026 8:35 AM
PR Newswire (US) Two-year data showed that pediatric patients with accelerated bone age at baseline experienced slowed bone age progression and improved predicted adult height with CRENESSITYCross-sectional caregiver survey data showed universal satisfaction with CRENESSITY, willingness to recommend treatment and increased optimism about their child's future quality of life following treatment initiationSAN DIEGO, June 15, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new two-year data from the Phase 3 CAHtalyst® Pediatric study showing positive growth outcomes in children and adolescents with classic congenital adrenal hyperplasia treated with CRENESSITY® (crinecerfont). Patients with advanced bone age at baseline experienced slowed bone age progression and improved predicted adult height after two years of treatment. These data were presented at the Endocrine Society's annual meeting, ENDO 2026, in Chicago. "Treatment decisions made during growth years can have lifelong implications for children and adolescents with classic congenital adrenal hyperplasia," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "Excess adrenal androgens can accelerate bone maturation and limit adult height. These two-year data suggest that sustained androgen control with CRENESSITY, combined with reduced glucocorticoid exposure, may help address abnormal growth in pediatric patients by slowing the advancement of bone age and narrowing the gap between bone age and chronological age."Pediatric participants who completed the 28-week, double-blind, placebo-controlled period and the subsequent six-month, open-label period of the CAHtalyst Pediatric study continued treatment with CRENESSITY in an ongoing, open-label extension.Slowed Bone Age Progression and Improved Predicted Adult HeightIn the subset of growing pediatric patients (n=41), changes in bone age and predicted adult height were evaluated at Month 24. Bone age was assessed using bone age standard deviation score (SDS), a measure that compares skeletal maturity to age- and sex-matched norms.Among those with advanced bone age at baseline (n=24), bone age SDS remained stable or improved in most patients with up to two years of CRENESSITY treatment. Mean bone age SDS decreased by 1.12, with a subset of patients (n=9) demonstrating reductions greater than two standard deviations. In this subset of patients, mean predicted adult height increased by 4.7 cm from baseline. Together the data suggest that sustained hormonal control and substantial glucocorticoid (GC) reductions enabled by CRENESSITY may positively influence growth during childhood and adolescence."Accelerated bone age is one of the most challenging complications we face when managing classic congenital adrenal hyperplasia in growing children because it can permanently affect adult height," said Maria G. Vogiatzi, M.D., Division of Endocrinology at Children's Hospital of Philadelphia, Principal Investigator for the CAHtalyst Pediatric study and lead author of the growth analysis. "Seeing stabilization and even improvement in bone age over two years in a subset of patients is encouraging and suggests meaningful progress in addressing a key driver of compromised growth during the critical development years."Caregiver-reported Survey Data Reflects Satisfaction with CRENESSITY and Increased OptimismTo further explore caregiver perspectives and patient experience following long-term treatment with CRENESSITY, a cross-sectional, caregiver-reported survey of eligible U.S. participants from the CAHtalyst Pediatric open-label extension (n=29; preliminary analysis) was conducted at patients' latest site visits.Among caregivers in the preliminary survey analysis, 100% (29/29) reported:Overall satisfaction with CRENESSITY.Likelihood to recommend CRENESSITY to others with classic congenital adrenal hyperplasia (CAH).Increased optimism about reducing risks of long-term impacts associated with high-dose steroid use, including 79% (23/29) who reported feeling less concern about steroid-associated weight gain.Nearly all respondents (97%, 28/29) reported greater overall hope for their child's future living with classic CAH, with 93% (27/29) indicating increased optimism about reducing long-term impact of high levels of adrenocorticotropic hormone and androgens.Across analyses, CRENESSITY was generally well tolerated through two years of treatment in pediatric patients, with no new safety signals observed during long-term follow-up.These analyses build on previously presented results showing that CRENESSITY enabled substantial, sustained reductions in mean GC dose over two years without compromising androgen control. Reduced GC exposure was associated with sustained improvements in clinical outcomes linked to long-term, supraphysiologic GC use, including insulin resistance, weight and body mass index. These findings suggest a reduction in cardiometabolic risk in pediatric patients with classic CAH.Presentations at the ENDO 2026 annual meeting included:CAHtalyst Adult Study Two-Year ResultsTitle: Weight-Related Outcomes and Insulin Resistance in Adults with Classic Congenital Adrenal Hyperplasia: 2-Year Results from the CAHtalyst Adult Study (Oral Presentation #ORF32-07)
Authors: Oksana Hamidi, D.O., et alTitle: Adults with Classic Congenital Adrenal Hyperplasia Taking Crinecerfont Demonstrated Sustained Decreases in Glucocorticoid Doses: 2-Year Results from the CAHtalyst Adult Study (Poster Presentation #SUN-458)
Authors: Irina Bancos, M.D., et alTitle: A Cross-sectional Survey on Quality of Life of Adults with Classic Congenital Adrenal Hyperplasia in the United States Participating in CAHtalyst Adult Open-Label Extension Study (Poster Presentation #SUN-467)
Authors: Sonal Vaid, M.D., et alTitle: Bone Outcomes in Adults with Classic Congenital Adrenal Hyperplasia Treated with Crinecerfont for Up to 2 Years in CAHtalyst Adult Study (Poster Presentation #SUN-468)
 Authors: Maria Vogiatzi, M.D., et alCAHtalyst Pediatric Study Two-Year ResultsTitle: Characterization of Children and Adolescents with Classic Congenital Adrenal Hyperplasia Who Had Slowed Bone Age Progression and Improved Height Prediction with Crinecerfont (Oral Presentation #ORF32-05)
Authors: Maria Vogiatzi, M.D., et alTitle: Long-term Crinecerfont Treatment Reduced ACTH and 17-Hydroxyprogesterone — Clinical Outcomes in Children and Adolescents with Classic Congenital Adrenal Hyperplasia: 2-Year Results from CAHtalyst Pediatric (Poster Presentation #SAT-465)
Authors: Natalie Nokoff, M.D., et alTitle: Long-term Crinecerfont Enables Sustained Decreases in Glucocorticoid Doses — Clinical Outcomes in Children and Adolescents with Classic Congenital Adrenal Hyperplasia: 2-Year Results from CAHtalyst Pediatric (Poster Presentation #SUN-465)
Authors: Kyriakie Sarafoglou, M.D., et al Additional Presentations Title: Long-Term Risk of Cardiometabolic Comorbidities Associated with Glucocorticoid Exposure and Androgen Control in Classic Congenital Adrenal Hyperplasia: A Cox Proportional Hazards Analysis from the CAHtalog Registry ("New Therapies and Perspectives for Congenital Adrenal Hyperplasia and Adrenal Insufficiency" Rapid Fire Presentation #ORF32-02 and Poster Presentation #MON-495)
Authors: Oksana Lekarev, D.O., et alTitle: Crinecerfont Treatment of Classic Congenital Adrenal Hyperplasia Due to 11ß-Hydroxylase Deficiency: A Case Series (Poster Presentation #SAT-466)
Authors: Kyriakie Sarafoglou, M.D., et alTitle: A Modified Delphi Panel of U.S. Endocrinologists to Align on Minimum Clinically Important Difference in Glucocorticoid Dose and Other Key Considerations in Classic Congenital Adrenal Hyperplasia (Poster Presentation #SAT-459)
Authors: Ahmed Khattab, M.D., et alAbout Congenital Adrenal Hyperplasia
Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal steroid hormones, such as cortisol, aldosterone and adrenal androgens. Severe enzyme deficiency leads to an inability of the adrenal glands to produce enough cortisol and, in approximately 75% of cases, aldosterone. Because individuals with CAH are typically still able to produce androgens, the unused precursors that would normally be used to make cortisol instead result in the production of excess amounts of androgens. If left untreated, CAH can result in adrenal crisis and even death.Exogenous glucocorticoids (GCs) are necessary to correct the endogenous cortisol deficiency, but historically, doses higher than those needed for cortisol replacement (supraphysiologic) have been used to lower the elevated levels of adrenocorticotropic hormone (ACTH) and adrenal androgens. However, GC treatment at supraphysiologic doses has been associated with serious and significant complications of steroid excess, including metabolic issues such as weight gain and diabetes, cardiovascular disease and osteoporosis. Additionally, long-term treatment with supraphysiologic GCs may have psychological and cognitive impacts, such as changes in mood and memory. Adrenal androgen excess has been associated with abnormal bone growth and development in pediatric patients, female health problems such as excess facial hair growth and menstrual irregularities, in addition to cardiometabolic and fertility issues in both sexes. The symptoms of high ACTH may include testicular adrenal rest tumors (TARTs).About CRENESSITY® (crinecerfont)
CRENESSITY is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist that reduces and controls excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a non-glucocorticoid (GC) mechanism for the treatment of classic congenital adrenal hyperplasia (CAH). Antagonism of CRF1 receptors in the pituitary has been shown to decrease ACTH levels, which in turn decreases the production of adrenal androgens and potentially the symptoms associated with CAH. The robust clinical study data demonstrate that lowering adrenal androgen levels with CRENESSITY enables lower, more physiologic dosing of GCs to replace missing cortisol.CRENESSITY comes in capsules and an oral solution. For adults 18 years of age and older, the recommended dosage is 100 mg twice daily taken orally with a meal. For pediatric patients four to 17 years of age weighing less than 55 kg (121 lbs), the recommended dosage is based on body weight and is administered twice daily, taken orally with a meal. For pediatric patients weighing more than 55 kg (121 lbs), the recommended dosage is 100 mg twice daily taken orally with a meal. Healthcare providers can work with patients to determine the appropriate formulation for use depending on patient needs. Patients receiving CRENESSITY should continue GC therapy for cortisol replacement.About the CAHtalyst® Studies
The Phase 3 CAHtalyst global registrational studies were designed to evaluate the safety, efficacy and tolerability of CRENESSITY® (crinecerfont) in children and adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The CAHtalyst studies were the largest-ever clinical trial program in classic CAH, including 285 pediatric and adult patients.The CAHtalyst Pediatric study included 103 pediatric patients four to 17 years of age. The study tested two questions. The first question evaluated whether four weeks of CRENESSITY treatment could improve androgen control. The second question evaluated whether an additional 24 weeks of CRENESSITY treatment enabled customized glucocorticoid (GC) down-titration while androstenedione levels were maintained or improved.The CAHtalyst Adult study included 182 adult patients 18 to 58 years of age. Similarly, the first question of the study evaluated whether four weeks of CRENESSITY treatment could improve androgen control, and the second question evaluated whether an additional 20 weeks of CRENESSITY treatment enabled GC reduction to physiologic range while androstenedione levels were maintained or improved.Data from the CAHtalyst Phase 3 studies supported approval of CRENESSITY by the U.S. Food and Drug Administration in December 2024. The open-label extension treatment portions of both studies are ongoing.Important InformationApproved Uses
CRENESSITY® (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH).IMPORTANT SAFETY INFORMATIONDo not take CRENESSITY if you:Are allergic to crinecerfont, or any of the ingredients in CRENESSITY.CRENESSITY may cause serious side effects, including:Allergic reactions. Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY.Risk of Sudden Adrenal Insufficiency or Adrenal Crisis with Too Little Glucocorticoid (Steroid) Medicine. Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk for sudden adrenal insufficiency or adrenal crisis. Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine.Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.The most common side effects of CRENESSITY in adults include tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain.The most common side effects of CRENESSITY in children include headache, stomach pain, tiredness, nasal congestion, and nosebleeds.These are not all the possible side effects of CRENESSITY. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.Dosage Forms and Strengths: CRENESSITY is available in 50 mg and 100 mg capsules, and as an oral solution of 50 mg/mL.Please see full Prescribing Information.About Neurocrine Biosciences, Inc.
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, CRENESSITY and CAHtalyst are registered trademarks of Neurocrine Biosciences, Inc.Forward-Looking StatementsIn addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from CRENESSITY for the treatment of classic congenital adrenal hyperplasia (CAH); the value and benefits CRENESSITY brings to patients with CAH, including its potential to help address abnormal growth in pediatric patients with CAH by slowing bone age progression and improving predicted adult height in patients with advanced bone age at baseline; the ability of Neurocrine Biosciences to ensure patients have access to CRENESSITY; and whether the results from our clinical trials of CRENESSITY are indicative of real-world results. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of CRENESSITY; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of CRENESSITY, including the extent to which patients and physicians accept and adopt CRENESSITY; whether CRENESSITY receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; risks associated with the Company's dependence on third parties for development and manufacturing activities related to CRENESSITY, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for CRENESSITY may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding CRENESSITY; risks that post-approval CRENESSITY commitments or requirements may be delayed; risks that CRENESSITY may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.© 2026 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-CFT-US-0061 06/2026 View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-new-two-year-crenessity-crinecerfont-data-demonstrating-improved-growth-measures-in-pediatric-patients-with-classic-congenital-adrenal-hyperplasia-at-endo-2026-302799743.htmlSOURCE Neurocrine Biosciences, Inc. Original: Neurocrine Biosciences Presents New Two-Year CRENESSITY® (crinecerfont) Data Demonstrating Improved Growth Measures in Pediatric Patients with Classic Congenital Adrenal Hyperplasia at ENDO 2026

Neurocrine Biosciences Presents New Clinically Meaningful Response Data on Treatment of Tardive Dyskinesia, Reinforcing the Efficacy of INGREZZA® (valbenazine) Capsules Across a Broad Range of PatientsJune 8, 2026 4:05 PM
PR Newswire (US) New 48-week KINECT® 4 post-hoc analysis shows 94% of participants treated with INGREZZA achieved either symptomatic remission or a clinically meaningful response (≥30% reduction from baseline in Abnormal Involuntary Movement Scale total score); INGREZZA is the only vesicular monoamine transporter 2 (VMAT2) inhibitor to demonstrate clinical remission in clinical trialsA separate claims analysis indicates high prevalence of hepatic risk factors among patients with tardive dyskinesia; INGREZZA is the only VMAT2 inhibitor with approved dosing in hepatic impairmentTogether, these data add to a growing body of evidence supporting the potential of INGREZZA to provide clinically meaningful therapeutic benefits to a wide range of patients with tardive dyskinesiaSAN DIEGO, June 8, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new post-hoc data from the KINECT® 4 clinical trial demonstrating that adults with tardive dyskinesia (TD) treated with INGREZZA® (valbenazine) capsules experienced clinically meaningful and robust improvements in involuntary movement severity, including those who did not meet the stringent symptomatic remission threshold. These results, together with findings from a large retrospective Medicare claims analysis evaluating hepatic risk factors among patients newly diagnosed with TD, were presented at the 2026 Psych Congress Elevate in Las Vegas. Previously presented data from the 48-week KINECT 4 study showed that 59% (61/103) of patients treated with once-daily INGREZZA achieved the stringent threshold for TD symptomatic remission, defined as an Abnormal Involuntary Movement Scale (AIMS) item score of 0 ("none") or 1 ("minimal movements") in each of the seven body regions. Symptomatic remission was achieved across TD movement severity subgroups, including 63% (38/60) of patients with moderate TD and 54% (23/43) of patients with severe TD. A new post-hoc analysis further demonstrated that clinically meaningful improvements were observed even among patients who did not meet the more stringent symptomatic remission threshold. Among the 41% of patients (42/103) who did not meet the symptomatic remission threshold at Week 48, 86% (36/42) achieved ≥30% total AIMS score reduction (characterized by the authors as clinically meaningful), and 67% (28/42) achieved ≥50% reduction."Treatment goals for tardive dyskinesia include achieving both meaningful reductions in movement severity and, when possible, reaching symptomatic remission, a stringent threshold characterized by absent or minimal involuntary movements across all seven body regions," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "This new analysis demonstrates that approximately 94% of patients treated with INGREZZA for 48 weeks either achieved symptomatic remission or experienced clinically meaningful reductions in their tardive dyskinesia movements. Notably, the benefits of treatment extended beyond patients who reached the stringent remission threshold, reinforcing the broad clinical impact of INGREZZA."Claims Analysis Underscores Importance of Evaluating Hepatic Risk Factors in TD Treatment DecisionsA separate retrospective Medicare claims analysis of more than 176,000 patients newly diagnosed with TD found that 90% of patients had at least one hepatic risk factor and 44% had three or more. Selected hepatic risk factors included metabolic conditions, such as type 2 diabetes, hypertension, hyperlipidemia and obesity, in addition to substance use-related factors, such as alcohol or drug abuse, are associated with chronic liver disease or hepatic impairment. These findings highlight the importance of evaluating hepatic risk factors when making individualized treatment decisions for TD, as chronic liver disease may progress without noticeable symptoms, and hepatic impairment may go unrecognized, particularly in mild cases. INGREZZA is the only vesicular monoamine transporter 2 inhibitor with approved dosing for patients with TD and coexisting hepatic impairment.Additional presentations at the 2026 Psych Congress Elevate included: Evidence-Based Recommendations for Treating Tardive Dyskinesia with a Vesicular Monoamine Transporter 2 InhibitorClinically Meaningful Improvements and Symptomatic Remission with Once-Daily Valbenazine in Adults with Tardive DyskinesiaPatients Taking Once-Daily Valbenazine Report Improved Quality of Life/Functionality and Experience Remission of Tardive Dyskinesia Symptoms with Once-Daily Valbenazine: Findings From KINECT-PROOnce-Daily Valbenazine Demonstrates Greater and More Predictable Exposure Than Deutetrabenazine Extended-Release: Results from a Positron Emission Tomography Study in Healthy Male AdultsCharacterizing Hepatic Risk Factors Among Medicare Patients with Tardive DyskinesiaAbout the KINECT 4 Phase 3 Study
KINECT 4 is a Phase 3, open-label study in which 163 participants with moderate to severe TD and underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder) received 48 weeks of open-label treatment with once-daily INGREZZA (40 mg or 80 mg capsules) followed by a four-week washout. Dosing was initiated at 40 mg/day in all participants, with escalation to 80 mg/day at Week 4 based on effectiveness and tolerability. Dose reduction to 40 mg was allowed in participants who could not tolerate the 80 mg dose. Patients were discontinued if the new dose was not tolerated.Participants experienced TD improvements during long-term treatment as demonstrated by mean change from baseline to Week 48 in AIMS total score (sum of items 1-7, evaluated by site raters) with INGREZZA 40 mg/day (-10.2) or 80 mg/day (-11.0). Consistent with previous studies, INGREZZA was generally well tolerated. After Week 4, treatment-emergent adverse events that occurred in ≥5% of all participants (combined dose groups) were urinary tract infection (8.5%) and headache (5.2%). Changes from baseline in psychiatric stability, vital signs, electrocardiogram parameters and laboratory test values were generally small and not clinically significant.About Tardive Dyskinesia 
Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be mild to severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S.About INGREZZA® (valbenazine) Capsules and INGREZZA® SPRINKLE (valbenazine) Capsules 
INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration. INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements. INGREZZA is studied across the widest range of patients. It is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules. Important Information Approved Uses 
INGREZZA®?(valbenazine) capsules or INGREZZA®?SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with: movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children. IMPORTANT SAFETY INFORMATION INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions.?Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself. Do not take INGREZZA or INGREZZA SPRINKLE if you:are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE.INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including:Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema.Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE.Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint.Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat.Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls. Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you:?have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take,?including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia?are?sleepiness and tiredness. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include?sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep. These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at?www.fda.gov/medwatch?or call?1-800-FDA-1088. Dosage Forms and Strengths:?INGREZZA and INGREZZA SPRINKLE are available in?40 mg, 60 mg, and 80 mg capsules. Please see full Prescribing Information, including Boxed Warning, and Medication Guide. About Neurocrine Biosciences, Inc.
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, INGREZZA and KINECT are registered trademarks of Neurocrine Biosciences, Inc. KINECT-PRO is a trademark of Neurocrine Biosciences, Inc.Forward-Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA, the interpretation and potential relevance of the data described in this press release, including statements regarding clinically meaningful reductions in involuntary movement severity, symptomatic remission, and hepatic risk factors among patients with tardive dyskinesia, and the value INGREZZA may bring to patients. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of INGREZZA; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA; whether INGREZZA receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA; risks that post-approval INGREZZA commitments or requirements may be delayed; risks that INGREZZA may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2026?Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0105   06/2026 View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-new-clinically-meaningful-response-data-on-treatment-of-tardive-dyskinesia-reinforcing-the-efficacy-of-ingrezza-valbenazine-capsules-across-a-broad-range-of-patients-302794193.htmlSOURCE Neurocrine Biosciences, Inc. Original: Neurocrine Biosciences Presents New Clinically Meaningful Response Data on Treatment of Tardive Dyskinesia, Reinforcing the Efficacy of INGREZZA® (valbenazine) Capsules Across a Broad Range of Patients

Neurocrine Biosciences Presents New Data Highlighting Functional and Socio-emotional Improvements with INGREZZA® (valbenazine) Capsules in Individuals with Tardive Dyskinesia and Intellectual and Developmental DisabilitiesJune 8, 2026 8:30 AM
PR Newswire (US) Nearly all individuals with intellectual and developmental disabilities experienced improvement in tardive dyskinesia severity after starting INGREZZA, and of those, 89% experienced improvement within 4 weeks Clinician-reported data showed improvements in key aspects of daily life following INGREZZA treatment in nearly all patients with tardive dyskinesia and intellectual and developmental disabilities who had impaired functionSAN DIEGO, June 8, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new clinician-reported data in patients with intellectual and developmental disabilities demonstrating meaningful and rapid improvements in tardive dyskinesia severity, as well as improvements in overall functional status, including physical and socio-emotional outcomes, with INGREZZA® (valbenazine) capsules. The findings were presented at the American Academy of Developmental Medicine and Dentistry's 24th Annual Education Conference in Dallas. These data highlight the significant burden associated with tardive dyskinesia (TD) in individuals with intellectual and developmental disabilities, as well as the rapid clinician-reported improvements seen in TD movements following treatment with INGREZZA. Clinicians also observed functional gains across multiple areas of daily living, including social and emotional well-being, communication abilities and motor skills, such as hand coordination."People with intellectual and developmental disabilities are at increased risk for tardive dyskinesia due to long-term antipsychotic use, yet the condition often goes underdiagnosed and its impact underrecognized," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "The clinician-reported improvements observed in this analysis complement patient-reported outcomes from the KINECT-PRO study, further highlighting the potential of INGREZZA to make a meaningful difference in areas that matter most to people living with tardive dyskinesia. This analysis, which is the first and only of its kind, also reflects our ongoing commitment to advancing studies that better represent and serve the diverse populations affected by the condition."This analysis was based on clinician-reported data from patients who initiated INGREZZA between January and June 2024, completed at least two months of treatment and had at least one follow-up visit, including a subgroup of 30 individuals with reported intellectual and developmental disabilities (mean age: 47.3 years; standard deviation: 14.6). The most common psychiatric comorbidities in this subgroup were schizophrenia (70%) and mood disorders (17%). Clinicians also reported that 70% of individuals had moderate or severe TD movement severity at baseline.Nearly all individuals experienced reductions in TD symptoms, with 89% (25/28) demonstrating improvement within four weeks of treatment initiation. Clinicians reported substantial burden associated with TD at baseline, with functional status and independence negatively impacted in 90% of individuals in the study due to their TD symptoms. Following treatment with INGREZZA, clinicians reported improvement in overall functional status in 96% of study participants with impaired function, as well as broad improvements across key aspects of daily life.OutcomeBaseline: % Patients 
Negatively ImpactedPosttreatment: % Patients
Improved*Overall functional status90 %96 %Independence 90 %83 %Emotions90 %85 %Socializing with family and friends83 %92 %Dexterity73 %91 %Speech53 %100 %*Percentage improved among patients who were negatively impacted at baselineA previous publication examined the use of INGREZZA in five adults with mild to severe intellectual and developmental disabilities and TD. Following treatment with INGREZZA, patients experienced reduced TD movements, accompanied by improvements in daily functioning, demeanor and social and caregiver interactions. The present analysis extends those findings, emphasizing the need to recognize the burden of TD beyond uncontrolled movements, including functional and socio-emotional outcomes that are especially meaningful for patients with intellectual and development disabilities, as well as their families and care partners.Additional presentation at the American Academy of Developmental Medicine and Dentistry's 24th Annual Education Conference included: Use and Misuse of Anticholinergics for Drug Induced Movement DisordersAbout Tardive Dyskinesia 
Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be mild to severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S. About the KINECT-PRO™ Phase 4 Study
The KINECT-PRO™ Phase 4, open-label study was designed to evaluate patient-reported outcomes on the use of INGREZZA® (valbenazine) capsules in a tardive dyskinesia (TD) patient population reflective of real-world clinical practice. Participants had at least mild TD, were aware of and experiencing at least mild distress from their abnormal, involuntary movements and had a clinical diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression. The KINECT-PRO study included a four-week screening period, a 24-week treatment period during which participants received 40 mg of INGREZZA once-daily for the first four weeks, followed by flexible dosing of 40 mg, 60 mg or 80 mg once-daily based on individual treatment needs and a two-week safety follow-up period. Baseline socio-demographic and clinical characteristics of the participants were broadly similar to those of the KINECT® 3 and KINECT® 4 studies.KINECT-PRO is the first and only study to specifically evaluate and demonstrate patient-reported improvement with vesicular monoamine transporter 2 inhibitor treatment on TD using multiple clinically validated scales, including the Tardive Dyskinesia Impact Scale (TDIS™). The TDIS is the only patient-reported outcome instrument designed for and validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition.About INGREZZA® (valbenazine) Capsules and INGREZZA® SPRINKLE (valbenazine) Capsules 
INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration. INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements. INGREZZA is studied across the widest range of patients. It is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules. Important Information Approved Uses 
INGREZZA®?(valbenazine) capsules or INGREZZA®?SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with: movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children. IMPORTANT SAFETY INFORMATION INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions.?Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself. Do not take INGREZZA or INGREZZA SPRINKLE if you:are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE.INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including:Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema.Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE.Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint.Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat.Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls. Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you:?have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take,?including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia?are?sleepiness and tiredness. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep. These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at?www.fda.gov/medwatch?or call?1-800-FDA-1088. Dosage Forms and Strengths:?INGREZZA and INGREZZA SPRINKLE are available in?40 mg, 60 mg, and 80 mg capsules. Please see full Prescribing Information, including Boxed Warning, and Medication Guide. About Neurocrine Biosciences, Inc. 
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, INGREZZA and KINECT are registered trademarks of Neurocrine Biosciences, Inc. KINECT-PRO and TDIS are trademarks of Neurocrine Biosciences, Inc.Forward-Looking Statements 
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA, the interpretation and potential relevance of the data described in this press release, including statements regarding improvements in patients' functional status and physical and socio-emotional outcomes following treatment with INGREZZA, and the other value INGREZZA may bring to patients. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of INGREZZA; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA; whether INGREZZA receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA; risks that post-approval INGREZZA commitments or requirements may be delayed; risks that INGREZZA may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2026?Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0103   06/2026 View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-new-data-highlighting-functional-and-socio-emotional-improvements-with-ingrezza-valbenazine-capsules-in-individuals-with-tardive-dyskinesia-and-intellectual-and-developmental-disabilities-302793148.htmlSOURCE Neurocrine Biosciences, Inc. Original: Neurocrine Biosciences Presents New Data Highlighting Functional and Socio-emotional Improvements with INGREZZA® (valbenazine) Capsules in Individuals with Tardive Dyskinesia and Intellectual and Developmental Disabilities

Neurocrine Biosciences to Present at Upcoming Investor Conferences in JuneMay 26, 2026 4:01 PM
PR Newswire (US) SAN DIEGO, May 26, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that its executives will participate at the following investor conferences: William Blair 46th Annual Growth Stock Conference. Fireside chat on Tuesday, June 2, 2026 at 10:40 AM CT (11:40 AM ET) in ChicagoGoldman Sachs 47th Annual Global Healthcare Conference 2026. Fireside chat on Tuesday, June 9, 2026 at 9:20 AM ET in MiamiThe webcasts can also be accessed on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of the webcasts will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.About Neurocrine BiosciencesNeurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)  The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-to-present-at-upcoming-investor-conferences-in-june-302782255.htmlSOURCE Neurocrine Biosciences, Inc. Original: Neurocrine Biosciences to Present at Upcoming Investor Conferences in June

Neurocrine Biosciences Presents Real-World Data Highlighting Functional Impact of Mild Tardive Dyskinesia Severity and Improvement with INGREZZA® (valbenazine) CapsulesMay 18, 2026 4:05 PM
PR Newswire (US) Clinician survey showed 90% of patients with mild tardive dyskinesia experienced emotional, social or physical impairmentFollowing initiation of INGREZZA, 96% of patients with mild tardive dyskinesia showed clinician-reported improvement in uncontrolled movements; of those patients, 86% improved within 4 weeksReductions in involuntary movements with INGREZZA treatment were associated with improvements in overall functional status, independence, activities of daily living and ability to workSAN DIEGO, May 18, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of new data from a clinician survey highlighting the functional impact experienced by patients with mild tardive dyskinesia (TD) severity and the impact of treatment with INGREZZA® (valbenazine) capsules in a real-world setting. In a subgroup analysis, nearly all patients with clinician-reported mild TD treated with INGREZZA experienced fewer uncontrolled movements, with most demonstrating symptom improvement within four weeks. Patients also showed widespread improvements in functional status, independence, ability to perform daily activities and ability to work. The findings are being presented at the American Psychiatric Association 2026 Annual Meeting, taking place May 16-20 in San Francisco. "A growing body of evidence shows that even tardive dyskinesia identified as mild in severity can meaningfully disrupt patients' daily functioning, impacting their physical, social and emotional well-being," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "These real-world results complement previously published patient-reported data highlighting both the functional impact of mild involuntary movements and the potential benefits of INGREZZA treatment. INGREZZA has been shown to improve tardive dyskinesia and associated functional outcomes that can help patients reclaim their independence and resume everyday activities."The analysis was based on a previously conducted clinician survey of patient chart data and clinician recall evaluating TD symptoms, functional impairment and improvement following treatment with INGREZZA. The survey included adult patients with TD who initiated INGREZZA between January 1, 2024 and June 30, 2024, completed at least two months of treatment and had at least one follow-up visit. In total, 128 clinicians caring for 315 patients with TD on INGREZZA reported data.This analysis focused on a subgroup of patients (n=90) with mild movement severity as rated by clinicians using global severity categories aligned with the Abnormal Involuntary Movement Scale. Prior to treatment, clinicians reported that mild TD movements impacted functional status in 90% of patients and independence in 84% of patients, with commonly affected areas including emotional (88%), social (86%), speech (61%), dexterity (60%) and eating (56%) functions.Following the initiation of INGREZZA, nearly all patients (96%) with mild TD experienced clinician-reported improvements in uncontrolled movements. Of those patients, 86% improved in four weeks or less. Beyond improvements in uncontrolled movements, clinicians observed meaningful functional improvements across a range of daily life domains among patients with mild TD:For patients with impacted functional status (n=81), almost all (96%) had improvement in overall functional status.Across all functional items, clinicians reported improvement in more than 90% of impacted patients, including those with impacted speech (n=55), dexterity (n=54), social status (n=77), emotional status (n=79) and activities of daily living, such as eating (n=50) and self-care (n=44).Among all patients, 83% (n=75/90) achieved improvement in independence with treatment.Among patients who were employed or attending school, 70% (n=21/30) experienced improved willingness or ability to work or attend school after initiating treatment.Findings from this survey and subpopulation analysis support the American Psychiatric Association clinical guidelines, which state that treatment with a vesicular monoamine transporter 2 inhibitor can be considered for patients with mild TD based on associated impairment or patient preference. This research adds to the growing body of evidence demonstrating the benefits of INGREZZA in patients with TD, including those with mild movements. In clinical studies, including the Phase 4 KINECT-PRO™ study, INGREZZA has been shown to improve TD severity and patients have reported reductions in the physical, social and emotional burden of the condition. Together, these real-world and clinical data highlight the potential of INGREZZA to improve movements and associated functional outcomes in patients with TD, including those with mild involuntary movements prior to treatment.About Tardive Dyskinesia 
Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be mild to severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S.  About the KINECT-PRO™ Phase 4 Study The KINECT-PRO™ Phase 4, open-label study was designed to evaluate patient-reported outcomes on the use of INGREZZA® (valbenazine) capsules in a tardive dyskinesia (TD) patient population reflective of real-world clinical practice. Participants had at least mild TD, were aware of and experiencing at least mild distress from their abnormal, involuntary movements and had a clinical diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression. The KINECT-PRO study included a four-week screening period, a 24-week treatment period during which participants received 40 mg of INGREZZA once-daily for the first four weeks, followed by flexible dosing of 40 mg, 60 mg or 80 mg once-daily based on individual treatment needs and a two-week safety follow-up period. Baseline socio-demographic and clinical characteristics of the participants were broadly similar to those of the KINECT® 3 and KINECT® 4 studies. KINECT-PRO is the first and only study to specifically evaluate and demonstrate patient-reported improvement with vesicular monoamine transporter 2 inhibitor treatment on TD using multiple clinically validated scales, including the Tardive Dyskinesia Impact Scale (TDIS™). The TDIS is the only patient-reported outcome instrument designed for and validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition. About INGREZZA® (valbenazine) Capsules and INGREZZA® SPRINKLE (valbenazine) Capsules 
INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration.  INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements.  INGREZZA is studied across the widest range of patients. It is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules.  Important Information Approved Uses 
INGREZZA® (valbenazine) capsules or INGREZZA® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with: movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children. IMPORTANT SAFETY INFORMATION INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions.?Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself. Do not take INGREZZA or INGREZZA SPRINKLE if you:are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE.INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including:Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema.Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE.Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint.Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat.Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls. Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you:?have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take,?including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia?are?sleepiness and tiredness. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include?sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep. These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at?www.fda.gov/medwatch?or call?1-800-FDA-1088. Dosage Forms and Strengths:?INGREZZA and INGREZZA SPRINKLE are available in?40 mg, 60 mg, and 80 mg capsules. Please see full Prescribing Information, including Boxed Warning, and Medication Guide. About Neurocrine Biosciences, Inc.
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, INGREZZA and KINECT are registered trademarks of Neurocrine Biosciences, Inc. KINECT-PRO and TDIS are trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements 
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA, the interpretation and potential relevance of the data described in this press release, including expectations as to how such data may relate to the therapeutic effects and clinical efficacy of INGREZZA, and the value INGREZZA may bring to patients. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of INGREZZA; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA; whether INGREZZA receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA; risks that post- approval INGREZZA commitments or requirements may be delayed; risks that INGREZZA may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2026?Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0101   05/2026 View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-real-world-data-highlighting-functional-impact-of-mild-tardive-dyskinesia-severity-and-improvement-with-ingrezza-valbenazine-capsules-302774948.htmlSOURCE Neurocrine Biosciences, Inc. Original: Neurocrine Biosciences Presents Real-World Data Highlighting Functional Impact of Mild Tardive Dyskinesia Severity and Improvement with INGREZZA® (valbenazine) Capsules

Neurocrine Biosciences Completes Acquisition of Soleno TherapeuticsMay 18, 2026 8:46 AM
PR Newswire (US) Strengthens Neurocrine's rare disease portfolio with VYKAT™ XR, the first and only approved treatment for hyperphagia in Prader-Willi syndromeAdds recently launched therapy with strong early adoption and meaningful commercial potentialSAN DIEGO, May 18, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the completion of its acquisition of Soleno Therapeutics, Inc., strengthening the company's leadership in endocrinology and rare disease. The acquisition adds VYKAT™ XR (diazoxide choline) tablets, the first and only approved medicine for hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome, to Neurocrine's first-in-class commercial portfolio alongside INGREZZA® (valbenazine) and CRENESSITY® (crinecerfont). "Today marks an important advancement in Neurocrine's mission to deliver life-changing treatments for patients with significant unmet needs," said Kyle W. Gano, Ph.D., Chief Executive Officer, Neurocrine Biosciences. "We welcome our Soleno colleagues to Neurocrine and share their deep commitment to the Prader-Willi syndrome community, and we look forward to working together to make VYKAT XR available to more patients and their families."Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in gene expression on chromosome 15 that affects about 10,000 patients in the United States. The disease is characterized by neurological, behavioral, and metabolic dysfunction. Its defining feature is hyperphagia, a chronic, life-threatening condition marked by a persistent hunger that drives compulsive food-seeking behavior. Individuals with PWS also commonly experience cognitive impairment and a range of psychiatric and behavioral challenges. Together, these symptoms can severely diminish quality of life for individuals with PWS and their families, with hyperphagia driving significant morbidity and mortality.Neurocrine initially announced the transaction – representing a total equity value of $2.9 billion – on April 6, 2026.Transaction Details
Neurocrine completed the cash tender offer through a subsidiary for all the outstanding shares of common stock of Soleno at a purchase price of $53.00 per share, without interest, subject to any applicable withholding taxes.As of the tender offer expiration at one minute after 11:59 p.m. EDT on May 15, 2026, 46,356,114 shares of Soleno common stock were validly tendered and not validly withdrawn, representing approximately 88.9% of the total number of Soleno's issued and outstanding shares of common stock as of such date and time. In accordance with the terms of the tender offer, all such shares have been accepted for payment.Following its acceptance of the tendered shares, Neurocrine completed its acquisition of Soleno through the merger of a direct wholly owned subsidiary of Neurocrine with and into Soleno, pursuant to Section 251(h) of the Delaware General Corporation Law on May 18, 2026, with Soleno continuing as the surviving corporation and becoming a direct, wholly owned subsidiary of Neurocrine. All remaining shares of Soleno common stock that were not validly tendered in the tender offer were converted into the right to receive the same $53 per share in cash, without interest, subject to any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. As of May 18, 2026, Soleno's common stock will no longer be listed or traded on the Nasdaq Capital Market.Advisors
Goldman Sachs & Co. LLC served as exclusive financial advisor, and Cooley LLP served as legal advisor to Neurocrine. Centerview Partners LLC and Guggenheim Securities, LLC served as financial advisors, and Wilson Sonsini Goodrich & Rosati, Professional Corporation served as legal counsel to Soleno.About PWS
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in gene expression on chromosome 15. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food-seeking behavior) and longer-term comorbidities such as diabetes, obesity, and cardiovascular disease.About INGREZZA® (valbenazine)
Please see additional safety information, full Prescribing Information, including Boxed Warning, and Medication Guide.About CRENESSITY® (crinecerfont)
Please see additional safety information and full Prescribing Information.About VYKAT XR
VYKAT XR was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025, and is now commercially available to U.S. patients.VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).INDICATION
VYKAT XR (diazoxide choline) extended-release tablets is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).IMPORTANT SAFETY INFORMATIONContraindications
Use of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides.Warnings and PrecautionsHyperglycemia
Hyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia.Risk of Fluid Overload
Edema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients.Adverse Reactions
The most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash.Please see the full Prescribing Information, including Medication Guide.About Neurocrine Biosciences
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, YOU DESERVE BRAVE SCIENCE, INGREZZA and CRENESSITY are registered trademarks of Neurocrine Biosciences, Inc. SOLENO is a registered trademark of Soleno Therapeutics, Inc. VYKAT is a trademark of Soleno Therapeutics, Inc.Forward-Looking Statements
This communication contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Neurocrine, including statements regarding Neurocrine's acquisition of Soleno, the prospective benefits of the acquisition; Neurocrine's strategy, plans, objectives, expectations (financial or otherwise) and intentions with respect to its future financial results and growth potential, anticipated product portfolio, and development programs; the estimated occurrence of PWS; the estimated U.S. population of PWS patients; and other statements that are not historical facts. The forward-looking statements contained in this communication are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. These statements may contain words such as "anticipate," "believe," "could," "estimate," "expect," "future," "intend," "may," "opportunity," "plan," "potential," "project," "seek," "should," "strategy," "will," "would" or other similar words and expressions indicating future results. Risks that may cause these forward-looking statements to be inaccurate include, without limitation: risks related to Neurocrine's ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period and that Neurocrine will not be able to integrate Soleno successfully or that such integration may be more difficult, time-consuming or costly than expected; disruption from the acquisition, making it more difficult to conduct business as usual or maintain relationships with employees, customers, suppliers, other business partners or governmental entities; negative effects of the consummation of the acquisition on the market price of Neurocrine's common stock and/or Neurocrine's operating results, including the possibility that if Neurocrine does not achieve the perceived benefits of the acquisition as rapidly or to the extent anticipated by financial analysts or investors, the market price of Neurocrine's common stock could decline; significant transaction and integration costs; unknown or inestimable liabilities; the risk of litigation and/or regulatory actions related to the acquisition; Neurocrine's ability to effectively commercialize VYKAT™ XR (diazoxide choline); the degree and pace of market uptake of VYKAT XR; obtaining and maintaining adequate coverage and reimbursement for Neurocrine's products, including VYKAT XR; the time-consuming and uncertain regulatory approval process; the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials; global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to Neurocrine's business operations and financial results; the sufficiency of Neurocrine's cash flows and capital resources; Neurocrine's ability to achieve targeted or expected future financial performance and results and the uncertainty of future tax, accounting and other provisions and estimates; and other risks and uncertainties affecting Neurocrine, including those described from time to time under the caption "Risk Factors" and elsewhere in Neurocrine's filings and reports with the U.S. Securities and Exchange Commission ("SEC"), including Neurocrine's Quarterly Report on Form 10-Q for the period ended March 31, 2026. Any forward-looking statements are made based on the current beliefs and judgments of Neurocrine's management team, and the reader is cautioned not to rely on any forward-looking statements made by Neurocrine. Except as required by law, Neurocrine does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. © 2026 Neurocrine Biosciences, Inc. All Rights Reserved. View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-completes-acquisition-of-soleno-therapeutics-302774688.htmlSOURCE Neurocrine Biosciences, Inc. Original: Neurocrine Biosciences Completes Acquisition of Soleno Therapeutics

Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBIP-'2118, a Corticotropin-Releasing Factor Type 2 Receptor AgonistMay 4, 2026 7:30 AM
PR Newswire (US)

NBIP-'2118 targets a new, non-incretin mechanism for weight loss with lean mass preservationSAN DIEGO, May 4, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 1 first-in-human clinical study evaluating the safety and tolerability of NBIP-'2118 in adult participants. NBIP-'2118 is an investigational corticotropin-releasing factor type 2 receptor (CRF2) peptide agonist and a potential first-in-class therapy for obesity.







"This program represents an important step in applying Neurocrine's expertise in CRF biology to treat metabolic disease," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "CRF2 agonism is a promising and differentiated mechanism with the potential to address key limitations of existing therapies, including the loss of lean mass during weight reduction. We believe this program could play a meaningful role as both a standalone therapy and in combination with other mechanisms, including incretin-based approaches."The Phase 1 study initially will evaluate the safety and tolerability of single ascending doses of NBIP-'2118 compared to placebo in healthy-weight adult participants, as well as those who are overweight or obese. Initial data is expected in 2027.NBIP-'2118 is an internally discovered and investigational CRF2 peptide agonist designed for once-weekly subcutaneous administration. In preclinical models, NBIP-'2118 demonstrated high selectivity and potency, with weight loss primarily driven by fat reduction while preserving or increasing lean mass, including skeletal muscle. By targeting CRF2 to both reduce fat and preserve muscle, NBIP-'2118 could be particularly beneficial for patients at risk of muscle loss with a differentiated profile from existing therapies which often attribute a significant proportion of weight loss to lean mass.Neurocrine's integrated obesity strategy includes multiple programs in preclinical development. NBIP-'1968 is an internally discovered, investigational triple agonist targeting GLP-1, GIP, and glucagon receptors and is intended for use in combination with NBIP-'2118, with the goal of achieving greater weight loss while maintaining muscle-sparing benefits. Neurocrine is also advancing a single-molecule incretin mimetic-CRF2 agonist conjugate. In addition, Neurocrine is developing a long-acting triple-agonist (targeting GLP-1, GIP, glucagon receptors) conjugated to an antibody Fc domain to extend half-life and potentially enable once-monthly or even less frequent dosing.About Obesity
Obesity is a chronic disease characterized by excess body fat and is associated with serious health conditions, including type 2 diabetes, cardiovascular disease and certain cancers. It is driven by complex biological, environmental, and genetic factors – not simply lifestyle or willpower. Obesity has reached epidemic levels globally, affecting a significant portion of adults and placing a substantial burden on public health systems. Despite recent advances in treatment, there remains a need for additional therapies that support safe, effective and sustainable long-term weight management.About Neurocrine Biosciences, Inc.
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine, psychiatric, and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)NEUROCRINE, the NEUROCRINE BIOSCIENCES logo and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc.Forward-Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the efficacy and therapeutic potential of NBIP-'2118, NBIP-'1968 and other preclinical programs for obesity. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing and commercialization activities for our products and product candidates and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2025. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.© 2026 Neurocrine Biosciences. Inc. All Rights Reserved. 



View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-initiation-of-phase-1-clinical-study-evaluating-nbip-2118-a-corticotropin-releasing-factor-type-2-receptor-agonist-302760552.htmlSOURCE Neurocrine Biosciences, Inc.

Original: Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBIP-'2118, a Corticotropin-Releasing Factor Type 2 Receptor Agonist

Neurocrine Biosciences Presents New Two-Year CRENESSITY® (crinecerfont) Data Demonstrating Durable Hormone Control, Reduced Glucocorticoid Exposure and Meaningful Clinical Improvements in Pediatric Patients with Classic Congenital Adrenal HyperplasiaMay 1, 2026 4:05 PM
PR Newswire (US)

At two years, 60% of patients who were overweight or obese at baseline experienced clinically meaningful improvements in body mass index, and 61% of those with insulin resistance at baseline were no longer insulin resistantImproved outcomes associated with excess androgens, including acne and androstenedione-to-testosterone ratio were also observedCRENESSITY delivered sustained reductions in adrenocorticotropic hormone and 17-hydroxyprogesterone, while enabling lower, more physiologic glucocorticoid dosingSAN DIEGO, May 1, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of new two-year data from the Phase 3 CAHtalyst® Pediatric study demonstrating durable androgen control, sustained decreases in glucocorticoid (GC) doses and meaningful improvements in clinical outcomes associated with excess androgens and long-term GC exposure in children and adolescents with classic congenital adrenal hyperplasia treated with CRENESSITY® (crinecerfont).







Consistent with these findings, patients with classic congenital adrenal hyperplasia (CAH) continued to experience substantial reductions in adrenocorticotropic hormone (ACTH) and 17-hydroxyprogesterone (17-OHP) while achieving lower, more physiologic GC doses. These data build upon previously reported one-year clinical outcomes results and were presented at the Pediatric Endocrine Society 2026 Annual Meeting in San Francisco."These two-year findings showed that CRENESSITY achieved durable reductions in both androgen levels and glucocorticoid doses in children and adolescents with classic congenital adrenal hyperplasia, a population particularly vulnerable to the long-term health impact of excess hormone exposure during growth and development," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "Improved hormonal control was associated with meaningful improvements in clinical outcomes, including body mass index and insulin resistance, supporting healthier outcomes as patients transition into adulthood."These findings highlight the broader clinical implications of improved hormonal control and reduced GC exposure in pediatric patients with classic CAH.The analysis included 86 participants aged four to 17 years who completed up to two years of CRENESSITY treatment in the open-label extension of the CAHtalyst Pediatric study. Mean changes from baseline in key hormonal markers, including ACTH and 17-OHP, measured prior to the morning GC dose, were reported through Month 24.ACTH and 17-OHP Reductions
Meaningful and durable reductions in mean ACTH and 17-OHP were observed at 12 months, with further reductions observed at 24 months, despite sustained decreases in GC doses during the same period.MeasureBaselineChange from
Baseline at
Month 12Change from
Baseline at
Month 24Mean ACTH (pg/mL)329(n=103)-118(n=93)-157(n=82)Mean 17-OHP (ng/dL)8,682(n=103)-1,698(n=94)-1,924(n=84)Mean daily GC dose (mg/m²/day hydrocortisone equivalents), observed16.4(n=103)-2.9(n=94)-3.2(n=84)Clinically meaningful improvements were observed across outcomes related to hormone control, excess androgens and long-term supraphysiologic GC exposure among relevant participants at baseline."In pediatric patients with classic congenital adrenal hyperplasia, excess androgens can accelerate bone age and drive early puberty, which can result in reduced final adult height. This, along with chronic supraphysiologic glucocorticoid exposure, can impact cardiometabolic health and quality of life in patients with CAH," said Mimi Kim, M.D., MSc, Associate Professor of Clinical Pediatrics, Keck School of Medicine, University of Southern California, Principal Investigator for CAHtalyst Pediatric. "These findings underscore the potential for CRENESSITY to redefine the treatment paradigm for patients with CAH by providing sustained control of androgens and allowing for significant reductions in glucocorticoid dosing – this could ultimately lead to important improvements in key long-term patient outcomes."Hormone Control and Excess Androgen OutcomesAmong patients with acne at baseline (visual analog scale [VAS] score >0; range 0-100; mean baseline score: 25.4 mm; n=58), mean acne severity decreased by 6.5 mm at Month 12 (n=52) and by 11.0 mm at Month 24 (n=43), indicating progressive improvement over time.In female participants with a baseline hirsutism VAS score >0 (mean baseline score: 27.3 mm; n=29), mean hirsutism scores were largely stable over two years, with a mean change of -6.3 mm at Month 12 (n=27) and +2.4 mm at Month 24 (n=21), despite lower GC doses and continued pubertal stage progression.Among male participants Tanner stage 2 or above with an androstenedione-to-testosterone (A4/T) ratio ≥0.5 at baseline (n=32), 31% (9/29) and 36% (9/25) achieved an A4/T ratio

Neurocrine Biosciences Presents New Two-Year CRENESSITY® (crinecerfont) Data Showing Sustained Glucocorticoid Dose Reductions While Maintaining Androgen Control in Adults with Classic Congenital Adrenal HyperplasiaApril 22, 2026 4:05 PM
PR Newswire (US)

Approximately 70% of adult patients treated with CRENESSITY achieved and sustained physiologic-range glucocorticoid dosing at two years75% of patients originally taking dexamethasone transitioned off this treatment, enabling a more physiologic glucocorticoid regimen without compromising androgen controlFindings reinforce durable efficacy and a favorable long-term safety profile in largest interventional trial to date conducted in classic congenital adrenal hyperplasiaSAN DIEGO, April 22, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the first presentation of new two-year data from the Phase 3 CAHtalyst® Adult study demonstrating sustained, substantial reductions in glucocorticoid (GC) doses in adults with classic congenital adrenal hyperplasia treated with CRENESSITY® (crinecerfont), with approximately 70% of patients achieving GC doses within the physiologic range. These data build upon previously reported one-year results and were presented at the American Association of Clinical Endocrinology 2026 Annual Meeting in Las Vegas.







Chronic exposure to supraphysiologic GC doses is associated with cardiometabolic comorbidities, bone density reductions, mental health issues and other long-term health risks that contribute to the cumulative treatment burden faced by patients over their lifetimes. Reducing high-dose, long-term GC exposure represents one of the most important goals in the management of classic congenital adrenal hyperplasia (CAH)."For decades, the management of classic congenital adrenal hyperplasia has relied exclusively on supraphysiologic glucocorticoid dosing to control adrenal androgen and adrenocorticotropic hormone excess, exposing patients to significant cumulative long-term risks," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "These two-year findings demonstrated that CRENESSITY provided durable androgen control while enabling meaningful reductions in glucocorticoid exposure. Importantly, these reductions were sustained over time without new safety or tolerability concerns, supporting CRENESSITY as a long-term treatment option that advances the standard of care for people living with this complex condition."At Month 24 of the study, 69% (103/149) of participants achieved a physiologic GC dose (≤11 mg/m2/day hydrocortisone equivalents), with many participants eliminating nonphysiologic GC types. Of participants originally taking dexamethasone (n=20), 75% switched to a dexamethasone-free regimen, while 62% (37/60) of patients taking more than two doses of hydrocortisone per day were able to eliminate a dose outright. GC dose reductions and regimen changes were achieved without worsening androstenedione levels relative to baseline, indicating that lowering the GC dose was not achieved at the expense of androgen control.Measure Baseline Month 18 Month 24 Mean daily GC dose (mg/m²/day HCe*), observed 17.610.610.6Mean % change from baseline in GC dose, observed —-38 %-38 %Participants achieving physiologic GC dose(≤11mg/m²/day HCe*), n/N (%) 0/182 (0%) 114/161(71%) 103/149 (69%) *HCe denotes hydrocortisone equivalents.Long-term treatment with CRENESSITY was generally well tolerated, with more than 80% study retention at two years and no new safety signals observed."Many years of supraphysiologic glucocorticoid exposure increase the risk for long-term health consequences, which include obesity, diabetes, reduced bone density and psychosocial struggles," said Richard J. Auchus, M.D., Ph.D., Professor of Internal Medicine and Pharmacology, University of Michigan Medical School and Principal Investigator for the CAHtalyst Adult study. "These sequelae significantly impact quality of life and commonly develop with traditional CAH treatment regimens. The two-year findings provide important information on the durable benefit of treatment with CRENESSITY. Providers can confidently incorporate this additional knowledge to guide their management of adult patients with CAH into the future."Neurocrine will be sharing additional two-year data across clinical endpoints and outcomes at upcoming medical meetings.Additional presentation at the American Association of Clinical Endocrinology 2026 Annual Meeting includes: Cardiometabolic Outcomes Associated with Chronic Supraphysiologic Glucocorticoid Exposure and Crinecerfont Treatment: 1-Year Results from CAHtalyst AdultAbout Congenital Adrenal Hyperplasia 
Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal steroid hormones, such as cortisol, aldosterone and adrenal androgens. Severe enzyme deficiency leads to an inability of the adrenal glands to produce enough cortisol and, in approximately 75% of cases, aldosterone. Because individuals with CAH are typically still able to produce androgens, the unused precursors that would normally be used to make cortisol instead result in the production of excess amounts of androgens. If left untreated, CAH can result in adrenal crisis and even death. Exogenous glucocorticoids (GCs) are necessary to correct the endogenous cortisol deficiency, but historically, doses higher than those needed for cortisol replacement (supraphysiologic) have been used to lower the elevated levels of adrenocorticotropic hormone (ACTH) and adrenal androgens. However, GC treatment at supraphysiologic doses has been associated with serious and significant complications of steroid excess, including metabolic issues such as weight gain and diabetes, cardiovascular disease and osteoporosis. Additionally, long-term treatment with supraphysiologic GCs may have psychological and cognitive impacts, such as changes in mood and memory. Adrenal androgen excess has been associated with abnormal bone growth and development in pediatric patients, female health problems such as excess facial hair growth and menstrual irregularities, in addition to cardiometabolic and fertility issues in both sexes. The symptoms of high ACTH may include testicular adrenal rest tumors (TARTs). About CRENESSITY® (crinecerfont)
CRENESSITY is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist that reduces and controls excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a non-glucocorticoid (GC) mechanism for the treatment of classic congenital adrenal hyperplasia (CAH). Antagonism of CRF1 receptors in the pituitary has been shown to decrease ACTH levels, which in turn decreases the production of adrenal androgens and potentially the symptoms associated with CAH. The robust clinical study data demonstrate that lowering adrenal androgen levels with CRENESSITY enables lower, more physiologic dosing of GCs to replace missing cortisol. CRENESSITY comes in capsules and an oral solution. For adults 18 years?of age?and older, the recommended dosage is 100 mg twice daily taken orally with a meal. For pediatric patients four to 17 years of age weighing less than 55 kg (121?lbs), the recommended dosage is based on body weight and is administered twice daily, taken orally with a meal. For pediatric patients weighing more than 55 kg (121?lbs), the recommended dosage is?100 mg?twice daily taken orally with a meal. Healthcare providers can work with patients to?determine?the?appropriate formulation?for use depending on patient needs. Patients receiving CRENESSITY should continue GC therapy for cortisol replacement.? About The CAHtalyst® Studies
The Phase 3?CAHtalyst?global registrational studies were designed to evaluate the safety, efficacy and tolerability of CRENESSITY®?in children and adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The?CAHtalyst?studies were the largest-ever clinical trial program in classic CAH, including 285 pediatric and adult patients.?? The?CAHtalyst?Pediatric study included 103 pediatric?patients?four to 17 years?of age. The study tested two questions. The first question evaluated whether four weeks of CRENESSITY treatment could improve androgen control. The second question evaluated whether an additional?24 weeks?of CRENESSITY treatment enabled customized glucocorticoid (GC) down-titration while androstenedione levels were?maintained?or improved.??? The?CAHtalyst?Adult?study?included 182 adult patients 18 to 58 years?of age. Similarly, the first question of the study evaluated whether four weeks of CRENESSITY treatment could improve androgen control, and the second question evaluated whether an?additional?20 weeks?of CRENESSITY treatment enabled GC reduction to?physiologic?range while androstenedione levels were?maintained?or improved.?? Data from the?CAHtalyst?Phase 3 studies supported approval of CRENESSITY by the?U.S.?Food and Drug Administration?in?December 2024. The?open-label extension treatment portions of both studies are ongoing.?? Important Information? Approved Uses
CRENESSITY® (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH).? IMPORTANT SAFETY INFORMATION? Do not take CRENESSITY if you:? Are allergic to?crinecerfont, or any of the ingredients in CRENESSITY.? CRENESSITY may cause serious side effects, including:?? Allergic?reactions.?Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY.? Risk of Sudden Adrenal Insufficiency or Adrenal Crisis?with?Too Little Glucocorticoid (Steroid) Medicine.?Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk?for?sudden adrenal insufficiency or adrenal crisis. Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine.? Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions, including if you:?are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.? Tell your healthcare provider about all the medicines you take,?including prescription and over-the-counter medicines, vitamins and herbal supplements.? The most common side effects of CRENESSITY in adults include?tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain.? The most common side effects of CRENESSITY in children include?headache, stomach pain, tiredness, nasal congestion, and nosebleeds.? These are not all the possible?side effects of CRENESSITY. Call your healthcare provider for medical advice?about?side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch?at?www.fda.gov/medwatch?or call 1-800-FDA-1088.? Dosage Forms and Strengths:?CRENESSITY is available in 50 mg and?100 mg?capsules,?and as an oral solution of?50 mg/mL.? Please see full?Prescribing Information.? About Neurocrine?Biosciences, Inc.?? 
Neurocrine Biosciences?is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine, psychiatric and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit?neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube.?(*in collaboration with AbbVie)? The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, CRENESSITY and CAHtalyst are registered trademarks of Neurocrine Biosciences, Inc.Forward-Looking Statements 
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from CRENESSITY for the treatment of classic congenital adrenal hyperplasia (CAH); the value and benefits CRENESSITY brings to patients with CAH, including its potential to enable patients to transition toward more physiologic glucocorticoid dosing; the ability of Neurocrine Biosciences to ensure patients have access to CRENESSITY; and whether the results from our clinical trials of CRENESSITY are indicative of real-world results. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of CRENESSITY; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of CRENESSITY, including the extent to which patients and physicians accept and adopt CRENESSITY; whether CRENESSITY receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; risks associated with the Company's dependence on third parties for development and manufacturing activities related to CRENESSITY, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for CRENESSITY may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding CRENESSITY; risks that post-approval CRENESSITY commitments or requirements may be delayed; risks that CRENESSITY may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2025. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.  © 2026 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-CFT-US-0054   04/2026  



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Original: Neurocrine Biosciences Presents New Two-Year CRENESSITY® (crinecerfont) Data Showing Sustained Glucocorticoid Dose Reductions While Maintaining Androgen Control in Adults with Classic Congenital Adrenal Hyperplasia

Neurocrine Biosciences Announces Conference Call and Webcast of First Quarter 2026 Financial ResultsApril 14, 2026 4:01 PM
PR Newswire (US)

Conference Call and Webcast Scheduled for Tuesday, May 5SAN DIEGO, April 14, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that it has scheduled its first quarter 2026 financial results conference call and webcast for 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) on May 5, 2026.







The schedule for the press release and conference call / webcast is as follows:Q1 2026 Press Release: May 5, 2026 at 1:00 p.m. PT / 4:00 p.m. ETQ1 2026 Conference Call: May 5, 2026 at 1:30 p.m. PT / 4:30 p.m. ETDomestic Dial-In Number: 800-274-8461International Dial-In Number: 203-518-9814Conference ID: NBIXThe webcast can also be accessed on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.About Neurocrine Biosciences
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine, psychiatric and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc.



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Original: Neurocrine Biosciences Announces Conference Call and Webcast of First Quarter 2026 Financial Results

Neurocrine to Acquire Soleno Therapeutics, Expanding Its Endocrinology and Rare Disease PortfolioApril 6, 2026 7:00 AM
PR Newswire (US)

VYKAT™ XR (diazoxide choline) is the First and Only FDA Approved Treatment for Hyperphagia in Prader-Willi Syndrome and Represents a Transformative Therapy Expands Neurocrine's High-Growth Commercial Portfolio to Three First-in-Class Medicines Including INGREZZA® (valbenazine) and CRENESSITY® (crinecerfont)Establishes a Durable Platform for Long-Term Revenue Growth and Value Creation, Supported by Strong VYKAT XR Intellectual Property Estate Expected to Extend into the mid-2040sNeurocrine to Host Conference Call at 8:00 AM ET Today to Discuss Transaction SAN DIEGO and REDWOOD CITY, Calif., April 6, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) and Soleno Therapeutics, Inc. (Nasdaq: SLNO) today announced that Neurocrine has entered into a definitive agreement to acquire Soleno for $53.00 per share in cash, representing a total transaction equity value of $2.9 billion.







The acquisition of Soleno and the addition of VYKAT™ XR (diazoxide choline), a first-in-class therapy to treat hyperphagia, the defining feature of Prader-Willi syndrome (PWS), will expand Neurocrine's portfolio of innovative medicines and strengthen its leadership position in endocrinology and rare disease. Since its FDA approval and successful U.S. launch in the second quarter of 2025, VYKAT XR has demonstrated strong early adoption, generating $190 million in 2025 revenue, including $92 million for Soleno in the fourth quarter alone. When supported by Neurocrine's medical and commercial infrastructure, VYKAT XR is expected to continue to improve care for patients with PWS while delivering long-term value to Neurocrine shareholders following the close of the transaction."This transaction will advance Neurocrine's mission to deliver life-changing treatments while accelerating our revenue growth and portfolio diversification strategy. We share the Soleno team's deep commitment to the Prader-Willi syndrome community and look forward to leveraging our experience and capabilities to expand VYKAT XR's reach to benefit more patients, while further strengthening Neurocrine's leadership in delivering transformative medicines," said Kyle W. Gano, Ph.D., Chief Executive Officer, Neurocrine Biosciences. "We congratulate Soleno on developing and launching VYKAT XR, showing strong results in a complex disease and enabling broad utilization with a clear label, and we look forward to working together to continue to help patients in need.""Neurocrine is the right strategic partner to expand the reach of VYKAT XR in the Prader-Willi syndrome community given their experience in endocrinology and rare disease and their proven ability to execute successful commercial launches. We are excited to accelerate VYKAT XR's impact for PWS patients following completion of the transaction by leveraging Neurocrine's strong commercial capabilities," said Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno.PWS is a rare genetic neurodevelopmental disorder caused by an abnormality in gene expression on chromosome 15 that affects about 10,000 patients in the United States. The disease is characterized by neurological, behavioral, and metabolic dysfunction. Its defining feature is hyperphagia, a chronic, life-threatening condition marked by a persistent hunger that drives compulsive, food-seeking behavior. Individuals with PWS also commonly experience cognitive impairment and a range of psychiatric and behavioral challenges. Together, these symptoms can severely diminish quality of life for individuals with PWS and their families, with hyperphagia driving significant morbidity and mortality.Strategic Rationale and Financial Benefits of the Transaction The transaction is expected to:Strengthen Neurocrine's Leadership in Endocrinology and Rare Disease, and Advance a Diversified Portfolio of First-in-Class Medicines: Following the completion of the transaction, Neurocrine will have three marketed, first-in-class therapies: INGREZZA®, the vesicular monoamine transmitter 2 (VMAT2) market leader for the treatment of tardive dyskinesia and the chorea associated with Huntington's disease, with $2.51 billion in 2025 revenue; CRENESSITY®, approved in December 2024 for the treatment of classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency, with $301 million in 2025 revenue; and VYKAT XR, approved in March 2025 for the treatment of PWS, with $190 million in 2025 revenue for Soleno. Together, these medicines will position Neurocrine to deliver sustained revenue growth through the end of this decade.Add a First-in-Class Therapy with Durable Value Creation: VYKAT XR is the first and only FDA-approved therapy for hyperphagia with PWS in the United States. Following a successful launch in 2025, VYKAT XR is well positioned as the foundational first-line therapy for PWS and is supported by a strong intellectual property estate that is expected to extend into the mid-2040s, providing a durable platform for long-term value creation.Provide a Transformative Therapy Aligned with Neurocrine's Strategic Focus. PWS is a neurodevelopmental disorder, and VYKAT XR aligns well with Neurocrine's capabilities addressing diseases at the intersection of neuroscience and endocrinology. Alongside CRENESSITY and an emerging endocrinology portfolio, VYKAT XR will serve as a strong foundation to further build Neurocrine's leadership over time.Enhance Ability to Deliver Long-Term Shareholder Value: Upon closing, the acquisition of Soleno is expected to contribute to a more diversified and durable revenue base, expand Neurocrine's commercial reach, immediately enhance Neurocrine's growth profile, and increase scale to support sustained innovation and development. This is further supported by continued pipeline progress and disciplined capital allocation. Integration of Soleno's operations is expected to drive cost synergies and operational efficiencies as Neurocrine leverages its existing infrastructure.Transaction Terms and Financing
Under the terms of the merger agreement, Neurocrine, through a subsidiary, will commence a cash tender offer to acquire all of the outstanding shares of Soleno's common stock at a price of $53.00 per share, representing a premium of approximately 34% to Soleno's closing share price on April 2, 2026, and a premium of 51% to Soleno's 30-day volume-weighted average price (VWAP). The consummation of the tender offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of Soleno, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. Following the successful completion of the tender offer, a wholly owned subsidiary of Neurocrine will merge with Soleno and the outstanding Soleno shares not tendered in the tender offer will be converted into the right to receive the same $53.00 per share in cash paid in the tender offer. The transaction will be funded with cash on hand and Neurocrine plans to optimize its capital structure by taking on a modest amount of pre-payable debt. The transaction is not subject to any financing condition.The boards of directors of both companies have approved the transaction, which is expected to close within 90 days of this announcement, subject to satisfaction of customary closing conditions, including receipt of regulatory approvals.Neurocrine to Host Conference Call Today 
Neurocrine will hold a live conference call and webcast today at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time). Participants can access the live conference call by dialing 800-579-2543 (US) or 785-424-1789 (International) using the conference ID: NBIX. The webcast and accompanying slides can also be accessed at approximately 7:30 a.m. Eastern Time on Neurocrine's website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.Advisors
Goldman Sachs & Co. LLC is serving as exclusive financial advisor and Cooley LLP is serving as legal advisor to Neurocrine. Centerview Partners LLC and Guggenheim Securities, LLC are serving as financial advisors and Wilson Sonsini Goodrich & Rosati, Professional Corporation is serving as legal counsel to Soleno.About INGREZZA® (valbenazine)
Please see additional safety information, full Prescribing Information, including Boxed Warning, and Medication Guide.About CRENESSITY® (crinecerfont)
Please see additional safety information and full Prescribing Information.About Neurocrine Biosciences
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, YOU DESERVE BRAVE SCIENCE, INGREZZA, and CRENESSITY are registered trademarks of Neurocrine Biosciences, Inc.About PWS
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food-seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease.INDICATION
VYKAT XR (diazoxide choline) extended-release tablets is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).IMPORTANT SAFETY INFORMATIONContraindications
Use of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides.Warnings and PrecautionsHyperglycemia
Hyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia.Risk of Fluid Overload
Edema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients.Adverse Reactions
The most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash.Please see the full Prescribing Information, including Medication Guide.About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. Soleno's first commercial product, VYKAT XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome. For more information, please visit www.soleno.life.Forward-Looking StatementsThis communication contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of each of Soleno and Neurocrine, including statements relating to the ability to complete and the timing of completion of the transactions contemplated by the Agreement and Plan of Merger, dated as of April 5, 2026, by and among Soleno, Neurocrine, and the other parties thereto (the "Merger Agreement"), including the anticipated occurrence, manner and timing of the proposed tender offer; the parties' ability to satisfy the conditions to the consummation of the tender offer and the other conditions to the consummation of the subsequent merger set forth in the Merger Agreement; the possibility of any termination of the Merger Agreement; the prospective benefits of the proposed transaction; Neurocrine's strategy, plans, objectives, expectations (financial or otherwise) and intentions with respect to its future financial results and growth potential, anticipated product portfolio, development programs and patent terms; the estimated occurrence of PWS; the estimated U.S. population of PWS patients; and other statements that are not historical facts. The forward-looking statements contained in this communication are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. These statements may contain words such as "anticipate," "believe," "could," "estimate," "expect," "future," "intend," "may," "opportunity," "plan," "potential," "project," "seek," "should," "strategy," "will," "would" or other similar words and expressions indicating future results. Risks that may cause these forward-looking statements to be inaccurate include, without limitation: uncertainties as to the timing of the tender offer; uncertainties as to how many of Soleno's stockholders will tender their stock in the offer; the possibility that competing offers or acquisition proposals will be made; the possibility that various closing conditions in the Merger Agreement may not be satisfied or waived; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement; the possibility that the transaction does not close; risks related to the parties' ability to realize the anticipated benefits of the proposed transaction, including the possibility that the expected benefits from the proposed acquisition will not be realized or will not be realized within the expected time period and that Neurocrine will not be able to integrate Soleno successfully or that such integration may be more difficult, time-consuming or costly than expected; disruption from the proposed transaction, making it more difficult for either company to conduct business as usual or maintain relationships with employees, customers, suppliers, other business partners or governmental entities; negative effects of this announcement or the consummation of the proposed transaction on the market price of Neurocrine's common stock and/or Neurocrine's operating results, including the possibility that if the parties do not achieve the perceived benefits of the proposed transaction as rapidly or to the extent anticipated by financial analysts or investors, the market price of Neurocrine's common stock could decline; significant transaction costs; unknown or inestimable liabilities; the risk of litigation and/or regulatory actions related to the proposed transaction; Neurocrine's ability to fund the proposed transaction; the time-consuming and uncertain regulatory approval process; the degree and pace of market uptake of Soleno's commercial product, VYKAT™ XR (diazoxide choline); the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials; global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to the parties' business operations and financial results; the sufficiency of Neurocrine's cash flows and capital resources; Neurocrine's ability to achieve targeted or expected future financial performance and results and the uncertainty of future tax, accounting and other provisions and estimates; and other risks and uncertainties affecting Neurocrine and Soleno, including those described from time to time under the caption "Risk Factors" and elsewhere in Neurocrine's and Soleno's respective filings and reports with the U.S. Securities and Exchange Commission ("SEC"), including their respective Annual Reports on Form 10-K for the fiscal year ended December 31, 2025 and subsequent Quarterly Reports on Form 10-Q and other filings filed with the SEC, as well as the Tender Offer Statement on Schedule TO and related tender offer documents to be filed by Neurocrine and its acquisition subsidiary, and the Solicitation/Recommendation Statement on Schedule 14D-9 to be filed by Soleno. Any forward-looking statements are made based on the current beliefs and judgments of Neurocrine's and Soleno's respective management teams, and the reader is cautioned not to rely on any forward-looking statements made by Neurocrine or Soleno. Except as required by law, Neurocrine and Soleno do not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.Additional Information about the Acquisition and Where to Find ItThe tender offer for all of the outstanding shares of Soleno described in this communication has not yet commenced. This communication is for informational purposes only, is not a recommendation and is neither an offer to purchase nor a solicitation of an offer to sell any securities, nor is it a substitute for the tender offer materials that Neurocrine and its acquisition subsidiary will file with the SEC upon commencement of the tender offer. A solicitation and offer to purchase outstanding shares of Soleno will only be made pursuant to an offer to purchase and related tender offer materials that Neurocrine and its acquisition subsidiary intend to file with the SEC. At the time that the tender offer is commenced, Neurocrine and its acquisition subsidiary will file a tender offer statement on Schedule TO, and Soleno will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED ACQUISITION AND THE PARTIES THERETO. INVESTORS AND STOCKHOLDERS OF SOLENO ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE (AND EACH AS IT MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND STOCKHOLDERS OF SOLENO SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SHARES OF COMMON STOCK IN THE TENDER OFFER. The tender offer materials (including the Offer to Purchase and the related Letter of Transmittal) will be made available at no expense on Neurocrine's website at neurocrine.com/investors and (once they become available) will be mailed to the stockholders of Soleno free of charge. The Solicitation/Recommendation Statement and other documents filed with the SEC by Soleno will be available at no expense at Soleno's website at investors.soleno.life. The information contained in, or that can be accessed through, Neurocrine's and Soleno's respective websites are not a part of, or incorporated by reference herein. The tender offer materials (including the Offer to Purchase and the related Letter of Transmittal), as well as the Solicitation/Recommendation Statement, will also be made available for free on the SEC's website at www.sec.gov. Copies of those offer documents and all other documents filed by Neurocrine and Soleno will be made available at no charge by directing a request to the information agent for the tender offer, which will be named in the Schedule TO. In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Neurocrine and Soleno each file annual, quarterly, and current reports, proxy statements and other information with the SEC. You may read any reports, statements or other information filed by Neurocrine or Soleno with the SEC for free on the SEC's website at www.sec.gov.



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Original: Neurocrine to Acquire Soleno Therapeutics, Expanding Its Endocrinology and Rare Disease Portfolio

Neurocrine unveils first expert guidance for tardive dyskinesia care in long-term facilitiesMarch 26, 2026 11:27 AM
IH Market News
Neurocrine Biosciences (NASDAQ:NBIX) on Thursday announced new expert consensus recommendations aimed at improving the screening, diagnosis and treatment of tardive dyskinesia (TD) among older adults living in long-term care settings.The recommendations were developed through a multidisciplinary Delphi panel and presented at the Society for Post-Acute and Long-Term Care Medical Association (PALTmed) PALTC26 Annual Conference in Anaheim, California. They represent the first guidance specifically tailored to managing TD in residents of long-term care facilities, a population considered at elevated risk for the movement disorder.Neurocrine also presented results from a post-hoc analysis of its KINECT PRO study, showing meaningful improvements in patient-reported TD impact among adults aged 65 and older treated with INGREZZA® (valbenazine) capsules. The company said the findings add to the evidence supporting the treatment’s efficacy, tolerability and safety profile in older patients.“To date, there has been limited practical guidance tailored specifically to the screening, diagnosis and treatment of tardive dyskinesia in the long-term care setting,” said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. “The consensus recommendations provide structured guidance for clinicians caring for residents in these environments, and the KINECT-PRO findings demonstrate clinically meaningful patient-reported improvements in the impact of tardive dyskinesia with INGREZZA in adults aged 65 years and older. Together, this guidance and evidence help support more informed treatment decisions in this population that may be at higher risk for tardive dyskinesia.”Older adults in long-term care facilities face heightened TD risk due to prolonged exposure to dopamine receptor-blocking medications, advanced age, polypharmacy and multiple underlying health conditions. Identifying and managing TD can be especially challenging in patients who are non-ambulatory, cognitively impaired or unable to clearly report symptoms.To address these challenges, the Delphi panel developed practical recommendations designed to help clinicians apply a more consistent and structured approach to TD evaluation and treatment in long-term care environments.“Residents in long-term care settings often present with overlapping medical and psychiatric complexities that can make tardive dyskinesia difficult to consistently recognize and manage,” said Amita Patel, M.D., the poster’s lead author and psychiatrist at the Joint Township District Memorial Hospital in St. Mary’s, Ohio. “Through this process, the panel reached clear consensus on practical, implementable recommendations that support evidence-based diagnosis and appropriate use of VMAT2 inhibitors. These recommendations provide clinicians with a structured framework to guide screening and treatment decisions to help improve outcomes for this especially vulnerable population.”



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Neurocrine Biosciences is a biopharmaceutical company focused on developing treatments for neurological, endocrine, psychiatric and immunological disorders. Its portfolio includes approved therapies for tardive dyskinesia, Huntington’s disease-related chorea, classic congenital adrenal hyperplasia, and women’s health conditions such as endometriosis and uterine fibroids.The company is also advancing a pipeline of mid- and late-stage clinical programs across several therapeutic areas. Over the past three decades, Neurocrine has focused on applying neuroscience insights to develop treatments aimed at addressing complex diseases affecting both the brain and broader physiological systems.Neurocrine Biosciences stock price

Original: Neurocrine unveils first expert guidance for tardive dyskinesia care in long-term facilities

Neurocrine Biosciences Presents First Expert Consensus Recommendations for Tardive Dyskinesia in Long-Term Care SettingsMarch 26, 2026 8:30 AM
PR Newswire (US)

Expert panel establishes structured approach to tardive dyskinesia screening, diagnosis and treatment in long-term care, including use of VMAT2 inhibitorsNew post-hoc KINECT-PRO™ analysis in adults aged 65 years and older demonstrates clinically meaningful patient-reported improvements in tardive dyskinesia impact with INGREZZA® (valbenazine) capsules, reinforcing expert panel recommendationsSAN DIEGO, March 26, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of the first expert consensus recommendations focused on screening, diagnosis and treatment of tardive dyskinesia among older adults in long-term care settings. Developed through a multidisciplinary Delphi panel, the recommendations address persistent gaps in recognizing and managing tardive dyskinesia in this higher-risk population. Findings were presented at the Society for Post-Acute and Long-Term Care Medical Association (PALTmed) PALTC26 Annual Conference in Anaheim, Calif.







The company also presented a first-of-its-kind post-hoc analysis from the KINECT-PRO™ study demonstrating meaningful improvements in patient-reported tardive dyskinesia (TD) impact among adults aged 65 years and older treated with INGREZZA® (valbenazine) capsules. This analysis adds to the growing body of evidence supporting the appropriateness, efficacy, tolerability and established safety profile of INGREZZA in this patient population."To date, there has been limited practical guidance tailored specifically to the screening, diagnosis and treatment of tardive dyskinesia in the long-term care setting," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "The consensus recommendations provide structured guidance for clinicians caring for residents in these environments, and the KINECT-PRO findings demonstrate clinically meaningful patient-reported improvements in the impact of tardive dyskinesia with INGREZZA in adults aged 65 years and older. Together, this guidance and evidence help support more informed treatment decisions in this population that may be at higher risk for tardive dyskinesia."Older adults in long-term care are at an elevated risk for TD due to prolonged exposure to dopamine receptor blocking agents, advanced age, polypharmacy and complex comorbidities. Recognition and management may be further complicated in residents who are non-ambulatory, cognitively impaired or unable to reliably report symptoms. The Delphi panel was convened to develop recommendations that reflect this clinical complexity and support a more consistent, structured approach to TD care."Residents in long-term care settings often present with overlapping medical and psychiatric complexities that can make tardive dyskinesia difficult to consistently recognize and manage," said Amita Patel, M.D., the poster's lead author and psychiatrist at the Joint Township District Memorial Hospital in St. Mary's, Ohio. "Through this process, the panel reached clear consensus on practical, implementable recommendations that support evidence-based diagnosis and appropriate use of VMAT2 inhibitors. These recommendations provide clinicians with a structured framework to guide screening and treatment decisions to help improve outcomes for this especially vulnerable population."Screening and Diagnosing TD in Long-Term Care Settings Requires a Holistic ApproachThe panel identified key considerations to support routine and consistent TD screening in long-term care settings. These include:Use of the Abnormal Involuntary Movement Scale (AIMS) for screening and assessing TD.Quarterly screening for residents treated with dopamine receptor blocking agents, the primary cause of TD.Regular assessment of the impact of TD on residents' well-being, including feedback from residents, family members, caregivers and the broader care team.Treatment Selection Should Consider Relevant Patient FactorsPanelists also reached consensus that TD should be treated with a vesicular monoamine transporter 2 (VMAT2) inhibitor in long-term care settings and identified several treatment-selection factors particularly relevant in these environments. These include:Formulation flexibility for residents who experience dysphagia or difficulty swallowing.Simplified administration, including the availability of a therapeutic starting dose.Consideration of polypharmacy and potential drug-drug interactions.Availability of clinical data in adults aged 65 years and older.These considerations underscore the importance of selecting a therapy with a clinical profile and administration characteristics that align with the needs of long-term care residents. INGREZZA is approved for the treatment of adults with TD and, among approved VMAT2 inhibitors:has been studied extensively in adults aged 65 years and older.is the only VMAT2 inhibitor without a cautious dosing recommendation in this population.is the only treatment that offers a therapeutic dose from day one with no required titration.is available in a sprinkle formulation.has a safety profile in adults aged 65 years and older that is consistent with that observed in patients younger than 65 years of age.*Phase 4 KINECT-PRO Findings Reinforce Significance of Expert Consensus GuidelinesA post-hoc analysis of the KINECT-PRO study complements the consensus recommendations by demonstrating the real-world impact of INGREZZA treatment in older adults. KINECT-PRO is the first and only clinical study to specifically evaluate and investigate patient-reported improvement with INGREZZA for TD using multiple validated scales, including the Tardive Dyskinesia Impact Scale (TDIS™).In adults aged 65 and older, once-daily INGREZZA was associated with robust patient-reported improvements in TD symptoms, quality of life and functional impairment at Week 24. Patient-reported outcomes also demonstrated reduced social and emotional burden, with improvements in total TDIS scores exceeding the established threshold for clinically meaningful change.Additional presentations at the Society for Post-Acute and Long-Term Care Medical Association (PALTmed) PALTC26 Annual Conference include: Management of Tardive Dyskinesia in Long-Term Care: Application of the 4Ms FrameworkPhysical, Mental, and Socioemotional Functional Improvement Following Valbenazine Treatment in Patients with TD Residing in Long-term Care SettingsValbenazine Treatment for Tardive Dyskinesia in a 64-Year-Old Female Presenting with Nonhealing Wounds due to Truncal Dyskinesias: A Case Report* Safety profiles as demonstrated in a post-hoc analysis from two 48-week studies (KINECT® 3 extension and KINECT® 4).About Tardive Dyskinesia 
Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be mild to severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S.  About the KINECT-PRO™ Phase 4 Study
The KINECT-PRO™ Phase 4, open-label study was designed to evaluate patient-reported outcomes on the use of INGREZZA® (valbenazine) capsules in a tardive dyskinesia (TD) patient population reflective of real-world clinical practice. Participants had at least mild TD, were aware of and experiencing at least mild distress from their abnormal, involuntary movements and had a clinical diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression. The KINECT-PRO study included a four-week screening period, a 24-week treatment period during which participants received 40 mg of INGREZZA once-daily for the first four weeks, followed by flexible dosing of 40 mg, 60 mg or 80 mg once-daily based on individual treatment needs and a two-week safety follow-up period. Baseline socio-demographic and clinical characteristics of the participants were broadly similar to those of the KINECT® 3 and KINECT® 4 studies. KINECT-PRO is the first and only study to specifically evaluate and demonstrate patient-reported improvement with vesicular monoamine transporter 2 inhibitor treatment on TD using multiple clinically validated scales, including the Tardive Dyskinesia Impact Scale (TDIS™). The TDIS is the only patient-reported outcome instrument designed for and validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition. About the Tardive Dyskinesia Impact Scale   
The Tardive Dyskinesia Impact Scale (TDIS™) is the only patient-reported outcome instrument designed for and validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition. It was developed by Neurocrine Biosciences from qualitative studies and Phase 3 trials of INGREZZA for the treatment of TD (KINECT® 3 and KINECT® 4) as a comprehensive measure of impact and burden of TD from a patient's perspective. The TDIS consists of 11 questions evaluating physical and socio-emotional impact. Six scales are assessed: mouth/throat, dexterity, mobility, pain, social and emotional. The TDIS allows people with TD to rate how their symptoms affect daily activities and how their uncontrollable movements make them feel. The questionnaire captures relevant information about the impact of TD to provide a more holistic assessment of the condition. Validation of this scale was published in the Journal of Patient-Reported Outcomes.  About INGREZZA® (valbenazine) Capsules and INGREZZA® SPRINKLE (valbenazine) Capsules 
INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration.  INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements.  INGREZZA is studied across the widest range of patients. It is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules.  Important Information Approved Uses 
INGREZZA®?(valbenazine) capsules or INGREZZA®?SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with: movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children. IMPORTANT SAFETY INFORMATION INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions.?Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself. Do not take INGREZZA or INGREZZA SPRINKLE if you:are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE.INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including:Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema.Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE.Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint.Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat.Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls. Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you:?have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take,?including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia?are?sleepiness and tiredness. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include?sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep. These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at?www.fda.gov/medwatch?or call?1-800-FDA-1088. Dosage Forms and Strengths:?INGREZZA and INGREZZA SPRINKLE are available in?40 mg, 60 mg, and 80 mg capsules. Please see full Prescribing Information, including Boxed Warning, and Medication Guide. About Neurocrine Biosciences, Inc. 
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine, psychiatric and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)  The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, KINECT and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc. KINECT-PRO and TDIS are trademarks of Neurocrine Biosciences, Inc.  Forward-Looking Statements 
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA, the interpretation and potential relevance of the data described in this press release, including statements regarding the use and interpretation of the Tardive Dyskinesia Impact Scale (TDIS™), and the value INGREZZA may bring to patients. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of INGREZZA; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA; whether INGREZZA receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA; risks that post-approval INGREZZA commitments or requirements may be delayed; risks that INGREZZA may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2025. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.  © 2026 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0094   03/2026



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Original: Neurocrine Biosciences Presents First Expert Consensus Recommendations for Tardive Dyskinesia in Long-Term Care Settings

Neurocrine Biosciences Appoints Andrew Ratz, Ph.D., as Chief Technical Operations OfficerMarch 17, 2026 4:05 PM
PR Newswire (US)

SAN DIEGO, March 17, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the promotion of Andrew Ratz, Ph.D., to the executive management team as the Chief Technical Operations Officer. In his new role, Dr. Ratz will lead the company's global technical development, manufacturing, and supply chain functions, supporting Neurocrine's expansion beyond small molecules into biologics and device-based therapies.







Dr. Ratz – who joined Neurocrine in January 2025 as Senior Vice President of Drug Development, Delivery and Device – previously spent nearly 30 years as an executive at Eli Lilly and Company. He had broad responsibility across Lilly's drug and device development and the delivery of innovative solutions spanning preclinical development through global manufacturing. Dr. Ratz contributed to the successful development and registration of more than 25 medicines across multiple therapeutic areas and drug modalities, supporting both biologic and small molecule portfolios."Since joining Neurocrine, Andy has brought visionary leadership and strategic focus to our R&D organization," said Kyle W. Gano, Ph.D., Chief Executive Officer, Neurocrine Biosciences. "His skills and experience will help guide the company as we advance the next generation of treatments for patients with significant unmet needs.""My career has been shaped by a focus on turning scientific innovation into real benefits for patients," Dr. Ratz said. "As a member of Neurocrine's leadership team, I look forward to helping build momentum around our efforts to develop therapies that can meaningfully improve patients' lives."Dr. Ratz received a Bachelor of Science degree in Chemistry from Indiana University and earned his Ph.D. in Chemistry from Harvard University.About Neurocrine Biosciences, Inc. 
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)The NEUROCRINE BIOSCIENCES logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, INGREZZA and CRENESSITY are registered trademarks of Neurocrine Biosciences, Inc.Forward-Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the Company's ability to execute its global technical development, manufacturing and supply chain strategies; the contributions Dr. Ratz may make in his role with the Company; and the value that the Company's products and/or product candidates may provide to patients. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: challenges that the Company may encounter in implementing the leadership transition; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, risks and uncertainties associated with the commercialization of INGREZZA and CRENESSITY; risks related to the development of our product candidates; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with government and third-party regulatory and/or policy efforts which may, among other things, impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products; risks associated with competition from other therapies or products, including potential generic entrants for our products; risks associated with our ability to manage the growth of our organization; and other risks described in our periodic reports filed with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2025. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than as required by law. © 2026 Neurocrine Biosciences, Inc. All Rights Reserved.










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Original: Neurocrine Biosciences Appoints Andrew Ratz, Ph.D., as Chief Technical Operations Officer

Neurocrine Biosciences Initiates Phase 2 Clinical Study Evaluating NBI-1065890 in Adults with Tardive DyskinesiaJanuary 26, 2026 1:30 PM
PR Newswire (US)

SAN DIEGO, Jan. 26, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of its Phase 2 clinical study of investigational compound NBI-1065890 in adults with tardive dyskinesia (TD). NBI-1065890 is a next-generation, selective inhibitor of the vesicular monoamine transporter 2 (VMAT2). Building on nearly 20 years of deep scientific expertise and experience in VMAT2 inhibition, Neurocrine designed NBI-1065890 to potentially deliver a differentiated profile, including the possibility of longer-acting options for the treatment of TD.







"NBI-'890 is an internally discovered molecule with distinct physical and chemical properties that may allow it to benefit a broader range of patients with tardive dyskinesia," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "Advancing this program to a Phase 2 clinical study is key to our strategy to define the future of VMAT2 biology and deliver lasting impact for patients."This Phase 2, randomized, double-blind, placebo-controlled study will enroll approximately 100 adult subjects with TD and will assess the efficacy, safety, and tolerability of NBI-1065890 compared with placebo. The primary efficacy endpoint is change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score (sum of Items 1–7) at Week 8.Neurocrine successfully developed and received U.S. Food and Drug Administration approval in 2017 for valbenazine, a selective VMAT2 inhibitor, for use as the first drug ever developed for the treatment of tardive dyskinesia. In 2023, the company received FDA approval for valbenazine as a treatment for chorea associated with Huntington's disease. For more information about the Phase 2 study (NBI-1065890-TD2033), visit ClinicalTrials.gov. About Tardive Dyskinesia
Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be mild to severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S. About NBI-1065890
NBI-1065890, discovered and developed internally at Neurocrine, is a potent, selective and orally bioavailable inhibitor of vesicular monoamine transporter 2 (VMAT2) in clinical development for the treatment of tardive dyskinesia (TD). Inhibition of VMAT2 is expected to provide therapeutic benefit in TD, other hyperkinetic movement disorders, and potentially other CNS disorders where dopaminergic signaling is dysregulated.About Neurocrine Biosciences, Inc.  
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on?LinkedIn, X,?Facebook and YouTube.?(*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES logo, NEUROCRINE and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc.Forward-Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the efficacy and therapeutic potential of NBI-1065890. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended September 30, 2025. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.© 2026 Neurocrine Biosciences, Inc. All Rights Reserved. 



View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-initiates-phase-2-clinical-study-evaluating-nbi-1065890-in-adults-with-tardive-dyskinesia-302669338.htmlSOURCE Neurocrine Biosciences, Inc.

Original: Neurocrine Biosciences Initiates Phase 2 Clinical Study Evaluating NBI-1065890 in Adults with Tardive Dyskinesia

🌿 Epilepsy: Cannabis vs. Synthetic Seizure Drugs
Medical cannabis: CBD oils and extracts are marketed as plant-based, holistic options. Families often see them as “natural relief” without the chemical baggage of traditional drugs.

Biotech/Pharma: Companies develop lab-engineered anti-seizure medications, often with complex side-effect profiles. Some pharma firms are even creating synthetic cannabinoids to patent and control.

The clash: Cannabis appeals to patients seeking authenticity and fewer side effects, while pharma emphasizes precision dosing and regulatory approval. $NBIX

$NBIX $MJNA on Epilepsy . https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176819269

NBIX 10 Q due Thursday

NBIX under $200

NBIX new 52=week high

NBIX over $30

NBIX new 52 hi

NBIX new 52 week high

NBIX new 52=week high

NBIX new 52 week high

NBIX new 52 week high

NBIX new 52 week high

https://finance.yahoo.com/m/ac97a7cc-59a6-39e8-8438-16d26de87a27/voyager%2C-neurocrine-sign-new.html

$NBIX short squeeze all day Neurocrine Biosciences Inc Nasdaq Nbix Short Squeeze

Recommended by Motley Fool

On watch list

News: $NBIX Neurocrine Biosciences and Voyager Therapeutics Announce Phase I Results for VY-AADC in Patients with Parkinson's Disease at the American Academy of Neurology Annual Meeting

SAN DIEGO and CAMBRIDGE, Mass. , May 5, 2019 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) and Voyager Therapeutics, Inc. (NASDAQ: VYGR) today announced Phase I trial results for VY-AADC from eight patients with Parkinson's disease who participated in the open-label t...

Read the whole news https://marketwirenews.com/news-releases/neurocrine-biosciences-and-voyager-therapeutics-announce-phase-i-results-for-vy-aadc-in-patients-with-parkinson-s-disease-at-the-american-academy-of-neurology-annual-meeting-8117554.html

News: $NBIX Neurocrine Biosciences Presents Phase III Data Analysis Demonstrating that Opicapone Added to Levodopa Resulted in a Significant and Sustained Increase in ON Time without Troublesome Dyskinesia in Parkinson's Disease Patients with Motor Fluctuations

SAN DIEGO , May 5, 2019 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced the presentation of a data analysis from two Phase III studies of opicapone, a novel, once-daily, oral, selective, peripherally-acting catechol-O-methyltransferase (COMT) inhibitor for...

Got this from https://marketwirenews.com/news-releases/neurocrine-biosciences-presents-phase-iii-data-analysis-demonstrating-that-opicapone-added-to-levodopa-resulted-in-a-significant-and-sustained-increase-in-on-time-without-troublesome-dyskinesia-in-parkinson-s-disease-patients-with-motor-flu-8117550.html

Why These 2 Biotech Stocks Might Be Next On The Takeover List

Acadia Pharmaceuticals (ACAD) and Neurocrine Biosciences (NBIX) stand out as potential takeover candidates among biotech stocks, an analyst said Friday.

,,,,,,,YOU PREDICT WRONG

Nice action lately??

107.20 is consensus target price and has the top banks maintaining NBIX is a buy rating. Tipranks.com also will show you this.

Based on??

I predict $NBIX will be $117.43 (or more) in 1 year, approximately.

Hi guys!
Any forecasts on price targets? I'm contemplating starting a position but not sure if it's too late. And given the stock jump, has there been a secondary offering?

Thx

NBIX buy 50.20

price crossed above a doji or spinning top









normal chart




log chart

NBIX bullish 52.71

recent gap up is FDA approval for Ingrezza drug product









normal chart




log chart

Nice win here!! Great news, should continue higher in the days to come, upgrades, ect.

$52.28 NHOD!!


THEY WERE TRYING TO FEND OFF 2.13 BREAK


HAHA


NBIX SHORTS GETTIN SPANKED

Ya, that big buy at $49 was a buy signal to me. Was $55 ish before without the news.

HIT $51.99 SO FAR

NBIX