Vanda Pharmaceuticals Inc (VNDA)

Vanda Pharmaceuticals Announces Participation at May 2026 Investor ConferencesMay 7, 2026 6:44 PM
PR Newswire (US) WASHINGTON, May 7, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate at the following upcoming investor conferences in May 2026: The Bank of America Securities Global Health Care Conference 2026 in Las Vegas, Nevada on Tuesday, May 12, 2026.The HCW 4th Annual BioConnect Investor Conference at Nasdaq in New York City on Tuesday, May 19, 2026. A fireside chat is scheduled for 2:00 p.m. Eastern Time.The B. Riley Securities 26th Annual Investor Conference in Marina Del Rey, California on Wednesday, May 20, 2026.The fireside chat given at the HCW 4th Annual BioConnect Investor Conference at Nasdaq may be accessed live on Vanda's corporate website, www.vandapharma.com. Investors should click on the Investors tab and follow the link under Recent Events. Investors are advised to go to the conference website at least 15 minutes early to register, download, and install any necessary software or presentations. A link to the archived conference will be available on Vanda's website for a period of approximately 30 days.About Vanda Pharmaceuticals Inc.Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.comJim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-participation-at-may-2026-investor-conferences-302766347.htmlSOURCE Vanda Pharmaceuticals Inc. Original: Vanda Pharmaceuticals Announces Participation at May 2026 Investor Conferences

Vanda Pharmaceuticals Announces U.S. Commercial Availability of NEREUS™ (tradipitant), the First New Pharmacologic Treatment for People with Motion Sickness in More Than 40 YearsMay 1, 2026 4:35 PM
PR Newswire (US)

Consumers can now order NEREUS™ directly at nereus.usWASHINGTON, May 1, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that NEREUS™ (tradipitant) is now commercially available across the United States for the prevention of vomiting induced by motion in adults, marking the first new prescription medicine approved for this condition in more than 40 years. An innovative direct-to-consumer order platform is now available through nereus.us.







Motion sickness affects an estimated 65 to 78 million Americans—roughly 25 to 30 percent of adults—during everyday travel by car, plane, or boat. For decades, patients have had no meaningful new treatment options. That changes today with NEREUS™, an oral neurokinin-1 (NK-1) receptor antagonist that offers a modern, targeted approach to a problem that has long lacked innovation."Today marks an important milestone for the tens of millions of Americans who experience motion sickness symptoms during common travel," said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of Vanda. "NEREUS™ is a selective, high-affinity antagonist of human substance P/neurokinin-1 (NK-1) receptors that can block the vomiting center of the brain. We are excited to make this innovative therapy available through both traditional pharmacy channels and our new direct-to-consumer platform at nereus.us, giving travelers, families, and anyone affected by motion sickness convenient access to a long-awaited solution."NEREUS™ is available now by prescription directly through nereus.us and retail pharmacies nationwide. Through the dedicated direct-to-consumer portal at nereus.us, patients with a valid prescription can access NEREUS™ at a cash-pay price of just $85 per dose, a meaningful discount from the standard list price of $255 per dose.Throughout history, motion sickness has repeatedly undermined military effectiveness and human exploration. During Napoleon's 1798 Egyptian campaign, soldiers in his newly formed camel corps—known as the "ships of the desert"—suffered debilitating nausea and vomiting from the animals' swaying gait, rendering many unfit for battle and even affecting Napoleon himself. On D-Day in 1944, thousands of Allied paratroopers endured violent air sickness during turbulent flights over the English Channel before they even reached Normandy. In the space age, nearly 70 percent of astronauts have faced space adaptation syndrome, a form of motion sickness that has challenged every major space program since the 1960s. For more than four decades, no new pharmacologic treatment emerged to address this ancient affliction—until today.Motion sickness may occur when the brain receives conflicting signals from the eyes, inner ear, and body while on motion. This sensory mismatch is believed to trigger the release of substance P, which activates NK-1 receptors in the central nervous system and ultimately leads to nausea and vomiting. NEREUS™ works by blocking these receptors, interrupting the vomiting pathway.The U.S. Food and Drug Administration approved NEREUS™ on December 30, 2025, following two pivotal Phase 3 clinical trials—Motion Syros and Motion Serifos—conducted under real-world conditions on the open sea. Both studies demonstrated that NEREUS™ significantly prevented vomiting compared to placebo, confirming the drug's effectiveness in actual sea travel conditions. It is the first new prescription option for people with history of motion sickness in over 40 years. It employs a novel mechanism as a selective, high-affinity antagonist of human substance P/NK-1 receptors. It offers simple dosing with just one or two capsules a day taken approximately an hour before travel.The commercial availability of NEREUS™ marks a historic milestone in addressing this highly prevalent physiological reaction to motion that has plagued humans for millennia.Visit nereus.us to access the direct-to-consumer portal and learn more about NEREUS™.About Vanda PharmaceuticalsVanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.About NEREUS™Indication and Important Safety Information for NEREUS™ (tradipitant) capsules.INDICATIONNEREUS™ (NEER-ee-us) [tradipitant] is a prescription medication used for the prevention of vomiting induced by motion in adults.IMPORTANT SAFETY INFORMATIONNEREUS™ may impair abilities required for driving a motor vehicle or operating heavy machinery. Combining NEREUS™ with sedatives or medications that increase NEREUS™ levels may increase this effect. If use together cannot be avoided, your doctor may warn against driving or operating heavy machinery.The most common side effects associated with NEREUS™ include drowsiness, headache, and fatigue.Tell your healthcare provider about all of the medicines you're taking. Strong CYP3A4 inhibitors may increase NEREUS™ levels and the risk of side effects.Tell your healthcare provider about all of your health conditions, including if you have liver or kidney problems, or if you are pregnant, planning to become pregnant, or breastfeeding. There are limited data on NEREUS™ use in pregnant women.Monitor breastfed infants for drowsiness.The safety and effectiveness of NEREUS™ for the prevention of vomiting induced by motion in children have not been established.NEREUS™ is not recommended in patients with liver problems or severe kidney problems.Consumer Important Safety InformationYou are encouraged to report side effects of prescription drugs to the FDA. To report side effects, contact Vanda Pharmaceuticals Inc. at 1-844-GO-VANDA (1-844-468-2632) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.For more information, ask your healthcare provider or call 1-844-468-2632.This information does not take the place of talking with your healthcare provider for medical advice about your condition or treatment.Download the full US Prescribing Information at nereus.us.NEREUS™ (tradipitant) is a neurokinin-1 receptor antagonist FDA approved for the acute prevention of vomiting induced by motion in adults, and is currently in clinical development for a variety of other indications, including gastroparesis and the prevention of nausea and vomiting induced by GLP-1 receptor agonists. For full Prescribing Information and other resources, please visit nereus.us.CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSVarious statements in this press release, including, but not limited to statements regarding the prevalence of motion sickness; the potential causes of motion sickness and the ways in which it may be triggered; and Vanda's further clinical development plans for NEREUS™ for various indications, including gastroparesis and vomiting induced by GLP-1 receptor agonists are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the accuracy of the estimates of the prevalence of motion sickness; Vanda's assumptions regarding the causes of motion sickness and the ways in which it may be triggered; and Vanda's ability to continue to advance tradipitant in gastroparesis and the prevention of nausea and vomiting induced by GLP-1 receptor agonists. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized, or even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.Corporate Contact:Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.comJim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com



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Original: Vanda Pharmaceuticals Announces U.S. Commercial Availability of NEREUS™ (tradipitant), the First New Pharmacologic Treatment for People with Motion Sickness in More Than 40 Years

Vanda Pharmaceuticals to Announce First Quarter 2026 Financial Results on May 6, 2026April 29, 2026 4:30 PM
PR Newswire (US)

Conference Call and Webcast to FollowWASHINGTON, April 29, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the first quarter 2026 on Wednesday, May 6, 2026, after the market closes.







Vanda will host a conference call at 4:30 PM ET on Wednesday, May 6, 2026, during which management will discuss the first quarter 2026 financial results and other corporate activities. To participate in the conference call, please dial 1-888-596-4144 (domestic) or 1-646-968-2525 (international) and use passcode 8051722.The conference call will be broadcast simultaneously and archived on Vanda's website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.A replay of the call will be available on Wednesday, May 6, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, May 13, 2026, at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 8051722.About Vanda Pharmaceuticals Inc.Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.comJim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-to-announce-first-quarter-2026-financial-results-on-may-6-2026-302757650.htmlSOURCE Vanda Pharmaceuticals Inc.

Original: Vanda Pharmaceuticals to Announce First Quarter 2026 Financial Results on May 6, 2026

"Generalized Pustular Psoriasis"?? That sounds super.

Vanda does such scary TV commercials. Can't wait to see the one for this!!

Vanda Pharmaceuticals announces the publication of "Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis" in NEJM EvidenceApril 28, 2026 7:12 PM
PR Newswire (US)

WASHINGTON, April 28, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of the original research article titled "Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis" in New England Journal of Medicine (NEJM) Evidence1.







The findings of this pivotal phase III study are included in the Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), submitted to the U.S. Food and Drug Administration (FDA) with a target action date of December 12, 2026.ReferencesSmieszek, S. et al. Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. NEJM Evidence 5, (2026). About ImsidolimabImsidolimab is a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling and is being developed for GPP, a rare orphan indication. Regulatory and patent exclusivity for imsidolimab is expected to extend into the late 2030s. Vanda holds an exclusive global license for the development and commercialization of imsidolimab from AnaptysBio (Nasdaq: ANAB).About Vanda PharmaceuticalsVanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSVarious statements in this press release, including, but not limited to statements regarding the anticipated timing of the completion of the FDA's review of the imsidolimab BLA; Vanda's plans to seek FDA approval of imsidolimab for the treatment of GPP; and the potential to extend regulatory and patent exclusivity for imsidolimab into the late 2030s, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the FDA's ability to complete its review of, and reach a decision with respect to, the imsidolimab BLA by December 12, 2026; Vanda's ability to obtain FDA approval of imsidolimab for the treatment of GPP; and Vanda's ability to satisfy the conditions necessary to extend regulatory and patent exclusivity for imsidolimab into the late 2030s. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized, or even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.comJim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-the-publication-of-efficacy-and-safety-of-imsidolimab-for-generalized-pustular-psoriasis-in-nejm-evidence-302756392.htmlSOURCE Vanda Pharmaceuticals Inc.

Original: Vanda Pharmaceuticals announces the publication of "Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis" in NEJM Evidence

Vanda Pharmaceuticals Appoints Dr. Charles Duncan to its Board of DirectorsApril 22, 2026 5:13 PM
PR Newswire (US)

WASHINGTON, April 22, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the appointment of Charles Duncan, Ph.D. to its Board of Directors effective April 22, 2026. Following Dr. Duncan's appointment, Vanda's Board of Directors is now comprised of seven directors, six of whom are independent.







Dr. Duncan is a highly experienced and respected leader in the life sciences and biotechnology sector," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "We are excited to welcome him to our strong and independent Board of Directors, where his deep industry expertise will complement our strengths as we advance our innovative pipeline in the service of patient needs."Dr. Duncan currently serves as the President of Sulci Advisors, LLC, a business advisory firm focused on the life sciences sector, a position he has held since founding the firm in September 2025. Prior to founding Sulci Advisors, LLC, Dr. Duncan spent nearly three decades as a sell-side biotechnology equity research analyst. From July 2018 until his retirement in June 2025, Dr. Duncan served as Managing Director and Senior Biotechnology Analyst at Cantor Fitzgerald & Co., where he initiated or assumed coverage on more than 70 companies, with a particular focus on neurology, psychiatry and platform-enabled therapeutics. From December 2012 to June 2018, Dr. Duncan served as Managing Director and Senior Biotechnology Analyst at Piper Jaffray & Co., where he initiated or assumed coverage on more than 40 companies and was recognized by Thomson Reuters StarMine for stock picking and earnings estimates. From September 2002 to December 2012, Dr. Duncan served as Managing Director, Supervisory and Senior Biotechnology Analyst at JMP Securities, LLC, where he was a founding healthcare partner and launched the firm's biotechnology research franchise.Earlier in his career, Dr. Duncan held biotechnology equity research positions at Dresdner Kleinwort Wasserstein Securities, Inc., Prudential Securities, Inc., Tucker Anthony Cleary Gull, Inc. and Chatfield Dean & Co., Inc., and previously served as a founder and board member of InfusionVision MEDical, Inc., a private venture capital-backed medical device company.Dr. Duncan received his Ph.D. in Pharmaceutical Sciences, with a concentration in Neuropharmacology, from the University of Colorado-Boulder and his B.S. in Zoology from the University of Wisconsin-Madison.Dr. Duncan joins the Vanda Pharmaceuticals board with broad industry perspectives and well-established experience translating clinical data and development plans for value creation to a diverse range of biotech stakeholders. "I am enthusiastic to join the Vanda board, especially at this potentially transformational period in the company's evolution," said Dr. Duncan. "Having covered a large number of Neuro-Innovator companies during my sell-side career, I see Vanda having a long history of innovation within CNS disorders, and it has served well patients in need. That said, with recent approvals of NEREUS™ and BYSANTI™, previous label expansion for Fanapt® and a growing pipeline to deliver impactful data over the next ~12 months, I believe Vanda has entered a new era of growth. I look forward to productive board service as management strives to create value broadly for stakeholders, including patients, payors, and shareholders."About Vanda Pharmaceuticals Inc.Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSVarious statements in this press release, including, without limitation, statements regarding Dr. Duncan's ability to assist Vanda in advancing its product pipeline in the service of patient needs, the delivery of impactful data over the next 12 months, Vanda's growth and the creation of value for stakeholders are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's assumptions regarding its ability to complete the clinical development and obtain regulatory approval for the products in its pipeline, the success of Vanda's clinical trials over the next 12 months and Vanda's ability to report positive results from the trials during such period, Vanda's ability to continue to grow its pipeline and portfolio of products and management's ability to create value for patients, payors and shareholders. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.comJim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-appoints-dr-charles-duncan-to-its-board-of-directors-302750882.htmlSOURCE Vanda Pharmaceuticals Inc.

Original: Vanda Pharmaceuticals Appoints Dr. Charles Duncan to its Board of Directors

Vanda Pharmaceuticals Calls on FDA to Withdraw Proposal from FY 2027 Legislative Agenda That Would Extend Drug Review TimelinesApril 9, 2026 11:02 AM
PR Newswire (US)

WASHINGTON, April 9, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today highlighted a legislative proposal contained in the FDA's FY 2027 Congressional Budget Justification.







The proposal would eliminate the simple statutory requirement that the FDA must review a new drug application (NDA) within 180 days of filing.In plain terms, this change would extend statutory review timelines rather than shorten them. It would replace the 180-day legal requirement with the longer Prescription Drug User Fee Act (PDUFA) and Generic Drug User Fee Amendments (GDUFA) performance goals. Under those goals, the FDA takes up to two months simply to decide whether to "file" the application. Only after that does the official review clock begin, resulting in typical total review times of 10 to 12 months from submission to decision.The proposal would also replace the formal evidentiary hearing process required by current law with a weaker, internal streamlined appeal. The FDA has avoided providing the statutorily mandated opportunity for a formal evidentiary hearing on drug non-approvals for over 40 years, until Vanda's successful litigation forced the agency to grant the first such hearing in more than four decades."The FDA's current practice of exceeding the 180-day statutory timeline by issuing Complete Response Letters and operating under longer PDUFA timelines has already been ruled by federal courts to violate the law," said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda Pharmaceuticals.  "Instead of complying with the law as written, this proposal asks Congress to change the law so the slower system becomes legal. This is especially concerning because Commissioner Makary said just days ago that the current two-month filing review is too long and should take just days—yet this proposal seeks to codify that very delay into law. At the same time, the FDA seeks to replace the formal hearing process with a streamlined internal appeal, despite the U.S. Court of Appeals for the D.C. Circuit having ruled only months ago that the FDA unlawfully denied Vanda a proper hearing in the HETLIOZ® jet-lag case, and after the agency was compelled to grant Vanda the first formal drug approval hearing statutorily required but effectively avoided by the FDA for more than forty years."Vanda supports genuine efforts to cut red tape and improve efficiency. However, this proposal does the opposite: it entrenches longer review times, reduces transparency for patients, and protects bureaucratic inertia instead of innovation. American patients would wait longer for needed medicines, while small innovators like Vanda would face greater financial risk and uncertainty.Vanda calls on FDA Commissioner Dr. Marty Makary to withdraw this provision from the FY 2027 legislative agenda and urges Congress to reject the proposal.About Vanda Pharmaceuticals Inc.Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.Corporate Contact:Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.comJim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.comFollow us on X @vandapharma



View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-calls-on-fda-to-withdraw-proposal-from-fy-2027-legislative-agenda-that-would-extend-drug-review-timelines-302738440.htmlSOURCE Vanda Pharmaceuticals Inc.

Original: Vanda Pharmaceuticals Calls on FDA to Withdraw Proposal from FY 2027 Legislative Agenda That Would Extend Drug Review Timelines

As some of you may know, Vanda makes some rather unusual commercials for its products. I cannot WAIT till we get to see what it comes up with for this vomit-stopper for patients taking GLP-1s!!

Vanda Pharmaceuticals Announces Initiation of The Thetis Study, a Clinical Trial of NEREUS™ for the Prevention of Vomiting Induced by GLP-1 Receptor AgonistsApril 8, 2026 4:44 PM
PR Newswire (US)

WASHINGTON, April 8, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the initiation of Thetis, a clinical trial evaluating NEREUS™ (tradipitant) for the prevention of vomiting in patients receiving glucagon-like peptide-1 (GLP-1) receptor agonist therapies. NEREUS™ was recently approved for the prevention of vomiting induced by motion.1







GLP-1 receptor agonists, including semaglutide and tirzepatide, have transformed the treatment of type 2 diabetes and obesity. However, gastrointestinal side effects, particularly nausea and vomiting, remain a significant challenge for many patients and are a leading cause of treatment discontinuation or dose reduction. Recent studies and approvals in the GLP-1 space further underscore this. Last month, a "high dose" of Wegovy was approved by the U.S. Food and Drug Administration (FDA) on the basis of providing additional weight-loss benefits, yet it comes with the tradeoff that the top two reported adverse effects of nausea and vomiting for this high dose are of increased frequency compared to the previously approved Wegovy maximum dose.2"GLP-1 receptor agonists offer significant benefits, but vomiting and nausea can severely impact patient adherence and quality of life," said Mihael H. Polymeropoulos, M.D., President CEO and Chairman of the Board of Vanda Pharmaceuticals. "NEREUS™ has demonstrated potent antiemetic effects in prior clinical studies. We are excited to advance this program, which has the potential to improve tolerability and allow more patients to fully benefit from these important therapies."The Thetis study is a multicenter, randomized, double-blind, placebo-controlled trial that will evaluate the efficacy and safety of oral tradipitant in patients initiated at a high dose of a GLP-1 receptor agonist. The primary endpoint is the proportion of patients free from vomiting episodes during the treatment period.The Phase 2 study, as previously announced in Vanda's press release dated November 15, 2025, was similar in design where patients were pre-treated with either tradipitant or placebo before administering a 1 mg injection of Wegovy®, a dose that normally takes 9 weeks of titration to reach. The phase 2 study succeeded and met its primary endpoint, with only 29.3% of tradipitant-treated participants (17/58) experiencing vomiting compared to 58.6% on placebo (34/58) (p=0.0016), representing a 50% relative reduction. The study also met the key secondary endpoint of the proportion of participants with vomiting and significant nausea at 22.4% in the tradipitant group (13/58) versus 48.3% on placebo (28/58) (p=0.0039).3Vanda expects topline results from the Thetis study by Q4 2026. Following completion of the Thetis study, additional study data may be required prior to approval of a New Drug Application (NDA).ReferencesSee full U.S. NEREUS Prescribing Information, available at: www.nereus.us.See full U.S. Wegovy Prescribing Information, available at: https://www.novo-pi.com/wegovy.pdf.See Vanda Pharmaceuticals Reports Positive Results for Tradipitant in Preventing GLP-1 Induced Nausea and Vomiting, available at: https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-positive-results-for-tradipitant-in-preventing-glp-1-induced-nausea-and-vomiting-302617739.html.About NEREUS™ NEREUS™ (tradipitant) is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company. NEREUS™ is approved for the acute prevention of vomiting induced by motion in adults, and is currently in clinical development for a variety of indications, including gastroparesis and the prevention of nausea and vomiting induced by GLP-1 receptor agonists. Full NEREUS™ Prescribing Information can be found at: https://www.nereus.us.About Vanda Pharmaceuticals Inc.Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSVarious statements in this press release, including, but not limited to, statements regarding the design, objectives and potential outcomes of the Thetis clinical trial; the potential benefits, effectiveness and safety of NEREUS™ (tradipitant) for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies; the significance of results from prior clinical studies; the expected timing of topline results from the Thetis study; and the risk that additional study data may be required prior to approval of an NDA, are "forward-looking statements" within the meaning of the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based on current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, risks inherent in clinical development, including the risk that the Thetis trial may not demonstrate efficacy or safety consistent with prior studies, may not meet its primary or secondary endpoints, or may experience delays; variability in patient response to therapy; regulatory considerations affecting the development of NEREUS™ for additional indications; and the risk that additional study data may be required prior to approval of an NDA. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the risks and uncertainties described in the sections titled "Cautionary Note Regarding Forward-Looking Statements," "Risk Factors," and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.All forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth herein. Vanda cautions investors not to place undue reliance on forward-looking statements. The information contained in this press release is provided as of the date hereof, and Vanda undertakes no obligation, and expressly disclaims any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.Corporate Contact:Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.comJim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.comFollow us on X @vandapharma



View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-initiation-of-the-thetis-study-a-clinical-trial-of-nereus-for-the-prevention-of-vomiting-induced-by-glp-1-receptor-agonists-302737472.htmlSOURCE Vanda Pharmaceuticals Inc.

Original: Vanda Pharmaceuticals Announces Initiation of The Thetis Study, a Clinical Trial of NEREUS™ for the Prevention of Vomiting Induced by GLP-1 Receptor Agonists

Vanda Pharmaceuticals Calls for Stronger FDA Action to Accelerate Shift from Animal Testing to Human-Relevant MethodsMarch 19, 2026 4:34 PM
PR Newswire (US)

WASHINGTON, March 19, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), a leader in innovative drug development and a vocal advocate for reducing unnecessary animal testing, today voiced serious concerns over the U.S. Food and Drug Administration (FDA)'s new draft guidance, "General Considerations for the Use of New Approach Methodologies in Drug Development," released March 18, 2026, by the Center for Drug Evaluation and Research (CDER).







The FDA's draft guidance aims to support the use of New Approach Methodologies (NAMs)—advanced non-animal tools like in vitro assays, organ-on-chip systems, computational models, and human cell-based platforms—to modernize nonclinical testing and move away from traditional animal models. While Vanda welcomes the FDA's stated commitment to improving human predictivity and ethical standards in drug development, the current draft falls short of delivering the bold, practical reform needed to make this transition a reality.Vanda has a proven track record of pushing for science-driven change, including legal efforts to challenge FDA requirements for prolonged animal studies—such as nine-month dog toxicity tests—that lack strong scientific justification. These efforts highlight the ethical imperative to minimize animal suffering, particularly in dogs, while advancing more predictive human-relevant methods."While we applaud the FDA's direction toward human-centric science, the draft guidance must strike a better balance between regulatory caution and the much-needed scientific reform that modern tools demand," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda Pharmaceuticals. "Patients deserve faster access to safer drugs, and ethical progress requires us to prioritize methods that better reflect human biology without unnecessary reliance on animals."Key shortcomings in the draft include:Not a single concrete example of any NAM that the FDA currently accepts today to fully replace a required animal test—despite mentioning general categories like in vitro assays for skin sensitization or eye irritation, the document provides zero specific, real-world illustrations, zero named assays or models with acceptance details, zero case studies of waived animal studies, and zero performance benchmarks from actual regulatory submissions or approvals.Limited scientific references and practical examples of validated NAMs, leaving developers without clear benchmarks for success.Insufficient transparency in authorship and limited citations, falling below the standards expected in credible scientific discourse.Vague validation requirements that lack streamlined approval pathways or concrete criteria, potentially creating uncertainty and slowing adoption of innovative tools.FDA leadership has repeatedly emphasized the limitations of animal studies in predicting human outcomes. Vanda urges the Agency to fully embrace this perspective by ensuring the final guidance removes barriers rather than introducing new ones.To help realize the promise of NAMs and accelerate safer, faster drug development, Vanda calls on the FDA to:Withdraw the current draft and substantially revise it with stronger scientific grounding.Incorporate robust citations to validated NAMs, peer-reviewed studies, and specific, concrete examples of NAMs that have been accepted to replace animal tests, including details on endpoints, performance data, and submission outcomes.Provide clear, expedited pathways for regulatory acceptance that prioritize human relevance and evidence-based confidence over outdated precedents.Actively collaborate with industry innovators, scientists, and animal welfare groups during the comment period to refine the guidance.Vanda stands ready to partner with the FDA, HHS, and stakeholders across the ecosystem to advance regulatory policies that harness cutting-edge science, protect patient safety, reduce animal suffering—including in dogs—and align with both ethical and scientific imperatives.About Vanda PharmaceuticalsVanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSVarious statements in this press release, including, but not limited to, statements regarding future regulatory developments and changes to current policies and practices regarding animal testing, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, future FDA or HHS policymaking. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized, or even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.comJim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-calls-for-stronger-fda-action-to-accelerate-shift-from-animal-testing-to-human-relevant-methods-302719227.htmlSOURCE Vanda Pharmaceuticals Inc.

Original: Vanda Pharmaceuticals Calls for Stronger FDA Action to Accelerate Shift from Animal Testing to Human-Relevant Methods

Vanda Pharmaceuticals Announces Participation in the 2026 Citizens Life Sciences ConferenceFebruary 26, 2026 4:35 PM
PR Newswire (US)

WASHINGTON, Feb. 26, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the 2026 Citizens Life Sciences Conference in Miami on Wednesday, March 11, 2026. A corporate presentation is scheduled for 2:15 p.m. Eastern Time.







The corporate presentation given at the Citizens Life Sciences Conference may be accessed live on Vanda's corporate website, www.vandapharma.com. Investors should click on the Investors tab and follow the link under Recent Events. Investors are advised to go to the conference website at least 15 minutes early to register, download, and install any necessary software or presentations. A link to the archived conference will be available on Vanda's website for a period of approximately 30 days.About Vanda Pharmaceuticals Inc.Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.comJim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com 



View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-participation-in-the-2026-citizens-life-sciences-conference-302699013.htmlSOURCE Vanda Pharmaceuticals Inc.

Original: Vanda Pharmaceuticals Announces Participation in the 2026 Citizens Life Sciences Conference

Vanda Pharmaceuticals Announces FDA Acceptance of Biologics License Application Filing for Imsidolimab for the Treatment of Generalized Pustular PsoriasisFebruary 25, 2026 7:18 AM
PR Newswire (US)

WASHINGTON, Feb. 25, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), with a target action date of December 12, 2026.







GPP is a rare, chronic, life-threatening autoinflammatory skin disorder characterized by sudden flares of widespread pustules, erythema, and systemic symptoms such as fever and fatigue. The pathogenesis of GPP is increasingly understood through its genetic characterization (OMIM #614204), and its molecular etiology is mainly attributed to excessive activity of the interleukin-36 (IL-36) pathway.1 The majority of GPP cases for which a causal single gene defect has been identified are caused by various consequential genetic variants in the IL36RN gene, encoding the IL-36 receptor antagonist (IL-36Ra).2,3,4Imsidolimab is a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling and is believed to achieve its therapeutic effects in GPP where IL-36 signaling is unbalanced. If approved, imsidolimab could address a significant unmet medical need in this rare and life-threatening disorder with potential benefits over currently existing treatments.Imsidolimab was studied in global clinical studies conducted in the United States, France, Spain, Poland, Turkey, Malaysia, Thailand, Georgia, Tunisia, Taiwan, and Morocco. In the pivotal efficacy studies GEMINI-1 and GEMINI-2, a single intravenous dose of imsidolimab led to rapid disease clearance, with 53% of patients achieving clear or almost clear skin (GPPPGA 0/1) at Week 4 compared to 13% on placebo. Efficacy was maintained throughout an approximately 2-year maintenance period with monthly doses, and no flares occurred in the active treatment arm. Imsidolimab exhibited a favorable safety profile and demonstrated a low incidence of anti-drug antibodies, which can be a significant advantage over existing treatments. GPP is a rare disorder with prevalence estimates varying widely by region, ranging from approximately 2 to 124 cases per million worldwide (lower in Europe and higher in parts of Asia).5,6"The acceptance of the BLA filing for imsidolimab marks a critical milestone in our efforts to bring this innovative therapy to patients suffering from GPP," said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda Pharmaceuticals. "Imsidolimab builds on our growing expertise in rare orphan disorders and our anti-inflammatory portfolio. Imsidolimab represents a precision medicine approach targeting a disorder with a known genetic cause using a fully humanized monoclonal antibody against the IL-36 receptor. We look forward to potential FDA approval and leveraging our commercial infrastructure to address this debilitating condition."Vanda celebrates this significant milestone for imsidolimab's acceptance for review by the FDA during Rare Disease Week on Capitol Hill (February 24–26, 2026), as advocates unite to promote innovation and access to treatments for rare orphan diseases like generalized pustular psoriasis.If imsidolimab is approved, it will be the third new drug product approved for Vanda in the past 12 months, following NEREUS™ (tradipitant) and BYSANTI™ (milsaperidone).ReferencesOnline Mendelian Inheritance in Man, OMIM®. Johns Hopkins University, Baltimore, MD. MIM Number: 614204: 12/16/2020. Available at: https://omim.org/Marrakchi, S. et al. Interleukin-36–Receptor Antagonist Deficiency and Generalized Pustular Psoriasis. New England Journal of Medicine 365, 620–628 (2011).Sugiura, K. et al. The Majority of Generalized Pustular Psoriasis without Psoriasis Vulgaris Is Caused by Deficiency of Interleukin-36 Receptor Antagonist. Journal of Investigative Dermatology 133, 2514–2521 (2013).Johnston, A. et al. IL-1 and IL-36 are dominant cytokines in generalized pustular psoriasis. Journal of Allergy and Clinical Immunology 140(1), 109–120 (2017).Sachen, K. L. et al. Role of IL-36 cytokines in psoriasis and other inflammatory skin conditions. Cytokine 156, 155897 (2022).Prinz, J. C. et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. Journal of the European Academy of Dermatology and Venereology 37, 256–273 (2022).About ImsidolimabImsidolimab is a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling and is being developed for GPP, a rare orphan indication. Regulatory and patent exclusivity for imsidolimab is expected to extend into the late 2030s. Vanda holds an exclusive global license for the development and commercialization of imsidolimab from AnaptysBio (Nasdaq: ANAB).About Vanda PharmaceuticalsVanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSVarious statements in this press release, including, but not limited to statements regarding the anticipated timing of the completion of the FDA's review of the imsidolimab BLA; imsidolimab's mechanism of action; the potential for imsidolimab to address a significant unmet medical need; the prevalence of GPP; potential FDA approval  of imsidolimab; Vanda's plans to leverage its commercial infrastructure to address GPP; and the potential to extend regulatory and patent exclusivity for imsidolimab into the late 2030s, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the FDA's ability to complete its review of, and reach a decision with respect to, the imsidolimab BLA by December 12, 2026; Vanda's assumptions regarding how imsidolimab achieves its therapeutic effect; Vanda's ability to obtain FDA approval of imsidolimab for the treatment of GPP; Vanda's ability to successfully execute the commercial launch of imsidolimab and to leverage its commercial infrastructure to reach patients with GPP; the ability of imsidolimab to safely and effectively treat GPP; the accuracy of the estimates of the prevalence of GPP; and Vanda's ability to satisfy the conditions necessary to extend regulatory and patent exclusivity for imsidolimab into the late 2030s. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized, or even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.comJim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-fda-acceptance-of-biologics-license-application-filing-for-imsidolimab-for-the-treatment-of-generalized-pustular-psoriasis-302696991.htmlSOURCE Vanda Pharmaceuticals Inc.

Original: Vanda Pharmaceuticals Announces FDA Acceptance of Biologics License Application Filing for Imsidolimab for the Treatment of Generalized Pustular Psoriasis

Vanda Pharmaceuticals Shares Surge Premarket Following FDA Approval of BysantiFebruary 23, 2026 10:31 AM
IH Market News
Shares of Vanda Pharmaceuticals (NASDAQ:VNDA) surged about 33% to $7.68 in premarket trading Monday after the company announced late Friday that the U.S. Food and Drug Administration had approved its drug Bysanti, sparking strong after-hours gains.The sharp move shifted investor focus to whether the rally can hold through regular trading, particularly after the stock had fallen 5.5% during Friday’s session before the approval news was released.Market participants are now closely watching Vanda’s next steps following the regulatory decision, as the company transitions from awaiting clinical milestones to preparing for commercialization. Key questions include how quickly prescriptions ramp up after launch and whether the price jump reflects sustained investor confidence or short-covering activity.Vanda said Friday that its antipsychotic treatment Bysanti received FDA approval for the treatment of schizophrenia and acute bipolar I disorder. The therapy targets dopamine and serotonin receptors, which play central roles in regulating mood and behavior.Vanda Chief Executive Officer Mihael H. Polymeropoulos described the approval of BYSANTI as “a significant step forward,” adding that it provides a “reliable new treatment” supported by the company’s clinical research. The company plans to begin commercial rollout in the third quarter of 2026.Bysanti, also known as milsaperidone, is bioequivalent to iloperidone across the full therapeutic dosing range, according to Vanda. The company already markets iloperidone under the Fanapt brand, a connection that could simplify commercialization but may also raise questions about product differentiation.Ahead of the decision, Jefferies analyst Andrew Tsai noted that Bysanti is “essentially more or less the same drug” as Fanapt, with similar efficacy and safety characteristics. He also highlighted the possibility that generic versions of Fanapt could enter the market as early as late 2027 or 2028, potentially pressuring pricing and demand.Vanda Pharmaceuticals stock price

Original: Vanda Pharmaceuticals Shares Surge Premarket Following FDA Approval of Bysanti

VNDA.......................https://stockcharts.com/sc3/ui/?s=VNDA&p=w&b=5&g=0&id=p86431144783

Vanda Pharmaceuticals Announces FDA Approval of BYSANTI™ (milsaperidone) for the treatment of Bipolar I Disorder and Schizophrenia - A New Chemical Entity Opening New Horizons in Psychiatric InnovationFebruary 20, 2026 5:59 PM
PR Newswire (US)

WASHINGTON, Feb. 20, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved BYSANTI™ (milsaperidone) tablets, a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults.







BYSANTI™ is a new chemical entity (NCE) that belongs in the class of atypical antipsychotics. In clinical studies BYSANTI™ demonstrated bioequivalence to iloperidone across the therapeutic dosing spectrum enabling it to leverage well-established knowledge of efficacy and safety derived from a rich clinical development program and more than 100,000 patient-years of real-world experience with Fanapt® (iloperidone). As such BYSANTI™ represents a novel therapeutic option with a trusted safety profile in the treatment of these serious psychiatric conditions."The BYSANTI™ approval marks a significant step forward, offering patients and providers a reliable new treatment grounded in extensive clinical heritage," said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda Pharmaceuticals. "BYSANTI™ exemplifies a new era of accelerated innovation in drug development that can transform how we address unmet needs in behavioral health."BYSANTI™ is currently being tested as a once-daily adjunctive treatment in treatment-resistant major depressive disorder in an ongoing clinical study expected to complete by the end of this year.BYSANTI™ (milsaperidone), a new chemical entity, rapidly interconverts to iloperidone, providing dual active molecules that work in tandem by antagonizing dopamine D2, serotonin 5-HT2A, and alpha1-adrenergic receptors to modulate key pathways in these disorders. Its safety profile aligns closely with that established for iloperidone.BYSANTI™'s unique in-class receptor binding profile, featuring strong alpha-adrenergic binding in excess of dopamine and serotonin receptor binding, makes it suitable for further investigation in conditions that include symptoms of hostility, agitation, and hyperarousal.Vanda anticipates commercial availability of BYSANTI™ in Q3 of 2026. BYSANTI™ marketing exclusivity is expected to be protected by regulatory data exclusivity and issued US patents, with the latest expiring in 2044, providing a robust foundation for long-term innovation and patient benefit.BYSANTI™ is the second new drug approval for Vanda in less than 2 months following the approval of NEREUS™ in December of 2025.About BYSANTI™To access the full Prescribing Information, including BOXED WARNING, visit www.bysanti.com.About Bipolar I Disorder and SchizophreniaBipolar I disorder impacts a significant portion of the roughly 10 million Americans with bipolar disorder, characterized by manic or mixed episodes that require effective symptom management to enhance outcomes.1 Schizophrenia affects approximately 1% of the U.S. adult population (about 2.8 million people), often causing substantial functional impairment, frequent hospitalizations, and diminished quality of life.2345ReferencesHarvard Medical School, 2007. National Comorbidity Survey (NSC). (2017, August 21). Potkin SG, et al. Efficacy of iloperidone in the treatment of schizophrenia: initial phase 3 studies. J Clin Psychopharmacol. 2008;28(2 Suppl 1):S4-S11. doi:10.1097/JCP.0b013e3181692787.  Cutler AJ, et al. Four-week, double-blind, placebo- and ziprasidone-controlled trial of iloperidone in patients with acute exacerbations of schizophrenia. J Clin Psychopharmacol. 2008;28(2 Suppl 1):S20-S28. doi:10.1097/JCP.0b013e318169278d.  Weiden PJ, et al. A Randomized Trial of Iloperidone for Prevention of Relapse in Schizophrenia: The REPRIEVE Study. J Clin Psychopharmacol. 2016;36(4):302-308. doi:10.1097/JCP.0000000000000516. (PMC4982888). Torres R, et al. Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2024;85(1):23m14966. doi:10.4088/JCP.23m14966. INDICATION AND IMPORTANT SAFETY INFORMATIONBYSANTI™ (milsaperidone) is an atypical antipsychotic indicated for the treatment of schizophrenia in adults and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS:Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. BYSANTI™ is not approved for use in patients with dementia-related psychosis.CONTRAINDICATIONSKnown hypersensitivity to milsaperidone or the inactive ingredients in BYSANTI™.WARNINGS AND PRECAUTIONSCerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack).QTc Interval Prolongation: may be associated with torsade de pointes and sudden death. Avoid concomitant use of BYSANTI™ with other drugs that prolong the QTc interval, and in patients with a significant risk of developing torsade de pointes; consider decreasing the BYSANTI™ dosage when prescribing BYSANTI™ with other drugs that inhibit milsaperidone metabolism or in CYP2D6 poor metabolizers. Monitor serum potassium and magnesium at baseline and during treatment in patients at risk for significant electrolyte disturbances.Neuroleptic Malignant Syndrome (NMS): If NMS is suspected, immediately discontinue BYSANTI™ and provide intensive symptomatic treatment and close monitoring.Tardive Dyskinesia: Discontinue if clinically appropriate.Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain.Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure in patients who are vulnerable to hypotension, and in those with known cardiovascular or cerebrovascular disease.Seizures: Use cautiously in patients with a history of seizures or with conditions that lower seizure threshold.Leukopenia, Neutropenia, and Agranulocytosis: Patients with a pre-existing low white blood cell count (WBC) or absolute neutrophil count or a history of drug induced leukopenia or neutropenia should have frequent monitoring of their complete blood count during the first few months of BYSANTI™ therapy and should discontinue BYSANTI™ at the first sign of a decline in WBC in the absence of other causative factors. Discontinue BYSANTI™ in patients with absolute ANC

Vanda Pharmaceuticals to Announce Fourth Quarter and Full Year 2025 Financial Results on February 11, 2026February 4, 2026 6:01 PM
PR Newswire (US)

Conference Call and Webcast to FollowWASHINGTON, Feb. 4, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the fourth quarter and full year 2025 on Wednesday, February 11, 2026, after the market closes.







Vanda will host a conference call at 4:30 PM ET on Wednesday, February 11, 2026, during which management will discuss the fourth quarter and full year 2025 financial results and other corporate activities. To participate in the conference call, please dial 1-888-596-4144 (domestic) or 1-646-968-2525 (international) and use passcode 8728050.The conference call will be broadcast simultaneously and archived on Vanda's website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.A replay of the call will be available on Wednesday, February 11, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, February 18, 2026, at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 8728050.About Vanda Pharmaceuticals Inc.Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer 
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com 



View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-to-announce-fourth-quarter-and-full-year-2025-financial-results-on-february-11-2026-302679562.htmlSOURCE Vanda Pharmaceuticals Inc.

Original: Vanda Pharmaceuticals to Announce Fourth Quarter and Full Year 2025 Financial Results on February 11, 2026

Nereus approved in December. Hetlioz is up for review next Wednesdya, and Bysanti in February. Really hope they make a triple.

VNDA,8.45,up 20%,fda approval of motion sickness drug,first in 40 years!
Co announced that the FDA has approved NEREUS, an oral neurokinin-1 receptor antagonist, for the prevention of vomiting induced by motion. This approval marks the first new pharmacologic treatment in motion sickness in over four decades, representing a significant advancement in the understanding and management of this debilitating physiologic response that affects a substantial portion of the population and has long been recognized as a factor affecting military operational readiness.

im a buyer at 5.07.nice triangle has formed. low float. plenty of cash on balance sheet. book value 9.20/sh

WOW talk about being lucky. Bought calls Friday for 2025 just in case something happens in 2024. Up 20% pre-market with an 8 all cash offer on the table.

VNDA under $7

Watching this closely

VNDA under $10

Early Barchart 100
https://www.barchart.com/stocks/performance/percent-change/advances?timeFrame=today&viewName=main&screener=overall&orderBy=percentChange&orderDir=desc

Over $6

Vanda acquired U.S. and Canadian rights to PONVORY® from a Johnson & Johnson Company on December 7, 2023. PONVORY® is approved by the U.S. Food and Drug Administration (FDA) and Health Canada to treat adults with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease (RMS).

In anticipation of the commercial launch of PONVORY® for RMS in the third quarter of 2024, Vanda is initiating a host of commercial activities including the creation of a specialty sales force, a prescriber awareness program and a comprehensive marketing program.

Gonna be a winner. Patience

Over 5$!

VNDA under $5

Let er rip $$$$$$$$

Agreed. This could double quickly

got this today...
very good trades.

This little gem could run up fast, they obviously have their science going in the right direction as the offers are there just not the price, could be a 10.00 offer in the works

Shares Outstanding 57,537,499 shares
Insider Shares 7,908,897 shares
Insider Ownership 13.75 %
Total Insiders 34

"The dividend distribution of rights will be payable to stockholders of record as of the close of business on April 29, 2024."

A shareholder may also receive distributions such as additional stock or stock rights in the distributing corporation; such distributions may or may not qualify as dividends.

A shareholder may also receive distributions such as additional stock or stock rights in the distributing corporation; such distributions may or may not qualify as dividends. You should receive a Form 1099-DIV, Dividends and Distributions from each payer for distributions of at least $10.

Guess we'll have to wait on the promised 8K.

Additional details of the Rights Plan will be contained in a Form 8-K to be filed by the Company with the U.S. Securities and Exchange Commission (the "SEC"). The filing will be available on the SEC's website at www.sec.gov.

Minimum 8$ imo

Vanda Pharmaceuticals rejects takeover proposal from Future Pak
REUTERS
1 mins ago
April 17 (Reuters) - Vanda Pharmaceuticals Inc (VNDA.NaE) on Wednesday said it is rejecting a takeover proposal from Future Pak, a privately-held contract manufacturer and packager of pharmaceuticals, as it significantly undervalues the company.

(Reporting by Sriparna Roy in Bengaluru; Editing by Tasim Zahid)

Early Barchart 100
https://www.barchart.com/stocks/performance/percent-change/advances?orderBy=percentChange&orderDir=desc

Probably...but I took it at 5.49

Will it grow legs after 9:30

VNDA Vol picking up..

$5.49 +$1.44 (+35.56%)

Volume 3,354,569

90 DAV... 2M

VNDA Here we go
$5.3781 +$1.3281 (32.79%)

Bid ARCX
5.36 x 10
Ask XNMS
5.38 x 11
Volume
2,971,106

VNDA Vol is good. Already @ 90 DAV
Volume 2,056,421
10/90-day avg. volume
7M / 2M

VNDA Good post, Laster.
https://www.futurepak.com/

The major question is who is Future Pak really?
Is this a legit offer?
Either way, company is extremely undervalued with no debt (I believe) and lots of cash.
Large short position. Lots of selling PM at $5.
Market does not seem to believe this offer. Sorry.

VNDA Float 52.05M

Shares Short (3/28/2024) 2.49M
Short Ratio (3/28/2024) 2.78
Short % of Float (3/28/2024) 5.45%

VNDA
Bid EDGX
4.85 x 3
Ask EDGX
4.88 x 3

Volume
1,790,654
Avg Vol (10 day) 6.63M

Vanda Pharmaceuticals
Closed .01 (-0.25%)

Pre-market
$5.15 +1.10 (+27.16%)
As of Apr-17-2024 7:23:52 AM ET
Bid x size $5.14 x 1
Ask x size $5.16 x 3

VNDA In 5.12. Let's see, said the blind man.

Vanda Pharmaceuticals jumps 38% on Future Pak's latest buy offer
Apr. 17, 2024 6:41 AM ETVanda Pharmaceuticals Inc. (VNDA) Stock