US Market News
2週前
Protagonist Therapeutics to Present Phase 3 VERIFY and Long-Term Rusfertide Data at the 2026 European Hematology Association CongressJune 1, 2026 7:05 AM
ACCESS NewswireNEWARK, CA / ACCESS Newswire / June 1, 2026 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced that four abstracts highlighting rusfertide in polycythemia vera (PV) will be presented at the 2026 European Hematology Association Congress (EHA2026 Congress), taking place June 11-14, 2026, in Stockholm, Sweden. The presentations include analyses from the randomized, controlled Phase 3 VERIFY study, as well as long-term results from the Phase 2 REVIVE and THRIVE open-label extension studies.The accepted abstracts provide additional perspective on the rusfertide clinical program in phlebotomy-dependent PV, including efficacy and safety outcomes across low-risk and high-risk patient subgroups, the effect of rusfertide on cytoreductive therapy use, long-term thromboembolic and disease progression events, and patient-reported symptom and fatigue measures.EHA2026 Presentations:Benefit of Rusfertide Maintained in Patients with Low-Risk or High-Risk Polycythemia Vera: Efficacy and Safety Subgroup Analysis from the Randomized Controlled Phase 3 VERIFY Study
Presenting Author: Valentin Garcia Gutierrez
Session Date & Time: Poster Session 1, Friday, June 12, 18:45-19:45 CEST
Poster Number: PF892Effect of Rusfertide on Cytoreductive Therapy Use in Patients with Phlebotomy Dependent Polycythemia Vera: Post Hoc Analysis from the Randomized Controlled Phase 3 VERIFY Study
Presenting Author: Francesca Palandri
Session Date & Time: Poster Session 1, Friday, June 12, 18:45-19:45 CEST
Poster Number: PF891Thromboembolic and Progression Events in Phlebotomy-Dependent Patients with Polycythemia Vera: Long-Term Results from the Phase 2 REVIVE and THRIVE Open-Label Extension Rusfertide Studies
Presenting Author: Naveen Pemmaraju
Session Date & Time: Poster Session 1, Friday, June 12, 18:45-19:45 CEST
Poster Number: PF890Impact of Rusfertide on Polycythemia Vera-Related Symptoms and Patient-Reported Outcome-Related Items in the Randomized, Double-Blind Phase 3 VERIFY Study
Presenting Author: Alessandro Lucchesi
Session Date & Time: Poster Session 1, Friday, June 12, 18:45-19:45 CEST
Poster Number: PF898About ProtagonistProtagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. The Company's proprietary peptide technology platform enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE™ (icotrokinra) is approved in the U.S. for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor (IL-23R) licensed to Janssen Biotech, Inc., a Johnson & Johnson company. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization. An NDA for rusfertide, a first-in-class hepcidin mimetic peptide that is being co-developed with Takeda Pharmaceuticals pursuant to a worldwide license and collaboration agreement entered in 2024, is under priority review with the FDA. Protagonist holds an option to co-commercialize rusfertide in the U.S. through a 50/50 profit and loss share structure or can opt-out of this structure. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com.Investor Relations Contact
Corey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com
+1 212 915 2577Media Relations Contact
Virginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061 ext 1SOURCE: Protagonist TherapeuticsView the original press release on ACCESS NewswireOriginal: Protagonist Therapeutics to Present Phase 3 VERIFY and Long-Term Rusfertide Data at the 2026 European Hematology Association Congress
US Market News
1月前
Protagonist Reports First Quarter 2026 Financial Results and Provides Corporate UpdateMay 5, 2026 4:05 PM
ACCESS NewswireICOTYDE™ (icotrokinra) approved by FDA in March for moderate-to-severe plaque psoriasis, triggering a $50 million milestone payment; Protagonist receives tiered royalties of 6% to 10% and is eligible for up to $580 million in future milestone paymentsRusfertide NDA accepted and granted Priority Review by FDA, with a Prescription Drug User Fee Act target action date in the third quarter of 2026Protagonist exercised its rusfertide opt-out right under the Takeda collaboration on April 28, triggering a $200 million opt-out fee payable to the Company; eligible for additional $200 million opt-out and $75 million milestone payments upon NDA approval, sales milestones of up to $775 million and worldwide royalties ranging from 14% to 29%PN-881 (oral IL-17 antagonist peptide) Phase 1 study completion by mid-2026 and Phase 2 initiation anticipated by year-end; PN-477sc and PN-477o (sc and oral triple GLP/GIP/GICG agonist) Phase 1 initiation expected in mid-2026 and Q1 2027, respectivelyCash, cash equivalents and marketable securities of $620 million as of March 31, 2026, anticipated to provide cash runway through at least 2028NEWARK, CA / ACCESS Newswire / May 5, 2026 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update."The first quarter of 2026 marked a series of landmark achievements for Protagonist, highlighted by the U.S. approval of ICOTYDE, FDA granting Priority Review for rusfertide, and advancement of our highly differentiated and fully-owned peptides PN-881 and PN-477," said Dinesh V. Patel, Ph.D., the Company's President and Chief Executive Officer. "These accomplishments, together with the additional financial resources afforded by our rusfertide opt-out election and future milestones and royalty payments from ICOTYDE and rusfertide, position Protagonist for meaningful near-, medium and long-term value creation through rapid progression of clinical stage assets and further expansion into new internal discovery programs. In addition, we look forward to implementing an efficient capital return strategy at the appropriate time."First Quarter 2026 Recent Developments and Upcoming MilestonesRusfertideOn March 2, Takeda and Protagonist announced that the U.S. FDA accepted the New Drug Application for rusfertide and granted Priority Review. The application is supported by data from the positive 32-week primary analysis and 52-week results from the Phase 3 global randomized VERIFY study, as well as four-year efficacy and safety data from the Phase 2 REVIVE study and long-term extension THRIVE study. The FDA set a PDUFA goal date in August 2026.On April 28, Protagonist announced that it exercised its right to opt out of the U.S. profit and loss sharing arrangement under the terms of its collaboration agreement with Takeda for rusfertide. The opt-out election triggers a $200 million payment to Protagonist, with an additional $200 opt-out fee and a separate $75 million milestone for FDA approval of rusfertide. The opt-out election also increases downstream economics payable to Protagonist, including up to $775 million in sales milestone payments and tiered worldwide royalties ranging from 14% to 29%. At $1.5 billion in annual net sales, the weighted-average royalty rate is approximately 21%, with the 29% tier applying to annual sales above $1.5 billion.ICOTYDE™ (icotrokina)On March 18, Protagonist announced that Johnson & Johnson received U.S. Food and Drug Administration approval for ICOTYDE for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. The FDA approval triggered a $50 million milestone payment to Protagonist in the first quarter of 2026. Under the collaboration, Protagonist remains eligible to receive up to $580 million in potential additional regulatory and sales milestone payments, as well as tiered royalties ranging from 6% to 10% on global net sales with an approximate 7.25% weighted-average royalty rate at $4 billion in annual net sales and a 10% tier applying to the incremental annual sales above $4 billion. ICOTYDE is the first and only FDA-approved targeted oral peptide for moderate-to-severe plaque psoriasisOn March 28, Protagonist announced presentation of new one-year Phase 3 ICOTYDE results at the 2026 American Academy of Dermatology Annual Meeting. Data from the Phase 3 ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD studies further supported the potential of ICOTYDE as a differentiated oral therapy for patients with moderate-to-severe plaque psoriasis, demonstrating durable efficacy and a favorable safety profile in a once-daily pill.Wholly-Owned Clinical and Discovery ProgramsPN-881 (oral IL-17 antagonist peptide): The Company expects completion of Phase 1 study by mid-2026 and initiation of a Phase 2 study by end of 2026.PN-477 (triple-G GLP/GIP/GCG agonist peptide): Phase 1 initiation of PN-477sc and PN-477o anticipated in mid-2026 and Q1 2027, respectively.PN-458 (dual GLP/GIP agonist peptide): IND-enabling studies in progress with PN-458sc and PN-458oPN-8047 (oral small molecule hepcidin functional mimetic): IND-enabling studies in progressDiscovery: Oral IL-4Ra antagonist and amylin oral mono/poly agonists are high-priority discovery programs.First Quarter 2026 Financial ResultsCash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2026, were $620.3 million as compared to $646.0 million as of December 31, 2025. Three Months Ended March 31, (in thousands, except per share amounts) 2026 2025 (Unaudited) License and collaboration revenue $56,368 $28,321 Research and development expense $46,739 $35,893 General and administrative expense $13,277 $11,738 Income tax benefit $1,502 $- Net income (loss) $3,783 $(11,655)Basic earnings (loss) per share $0.06 $(0.19) Diluted earnings (loss) per share $0.05 $(0.19) License and Collaboration Revenue: License and collaboration revenue of $56.4 million for the period ended March 31, 2026 consisted of (i) a $50.0 million milestone earned from JNJ in Q1 26 upon FDA approval of ICOTYDE, (ii) $3.3 million allocated to development services provided by us under the Takeda agreement during the period and (iii) $3.1 million cost reimbursement from Takeda for rusfertide clinical trial supplies. License and collaboration revenue of $28.3 million for the period ended March 31, 2025 consisted of (i) $22.8 million related to proportional recognition of a $25.0 million milestone earned in Q1 2025, and (ii) $5.5 million allocated to development services provided by us under the agreement during the period.Research and Development ("R&D") Expense: The increase in R&D expense from the prior year period was primarily due to increases related to our Phase 1 study for PN-881 and pre-clinical and drug discovery research expenses, including our obesity product candidates, partially offset by a decrease in rusfertide expenses related to the Phase 3 VERIFY clinical trial.General and Administrative ("G&A") Expense: The increase in G&A expense from the prior year period was primarily due to an increase in personnel-related expenses, including wages and benefits and stock-based compensation.Income Tax Benefit: Income tax benefit was $1.5 million for the period ended March 31, 2026 and included a discrete credit for stock-based compensation expense specific to the current quarter.Net Income (Loss): Net income was $3.8 million, or $0.06 per basic share and $0.05 per diluted share, for the first quarter of 2026 as compared to net loss of $11.7 million, or $0.19 per basic and diluted share, for the first quarter of 2025.About Protagonist
Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company with a proprietary technology platform that enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE™ (icotrokinra), licensed to Johnson & Johnson company Janssen Biotech, Inc., is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor. ICOTYDE was launched in the U.S. in March 2026, is approved for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age or older and is in Phase 3 development for psoriatic arthritis, ulcerative colitis and Crohn's disease. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization. Protagonist also discovered and led development through Phase 3 of rusfertide, a first-in-class hepcidin mimetic peptide licensed to Takeda Pharmaceuticals. An NDA for rusfertide for the treatment polycythemia vera is under priority review with the FDA. The Company also has a number of clinical and preclinical programs addressing clinically and commercially validated targets, including an oral IL-17 antagonist peptide, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com.Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding potential revenue from the Company's collaborations with Johnson & Johnson and Takeda, timing of regulatory actions and clinical trial completion, and advancement of the Company's discovery and clinical pipeline. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone and royalty payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.Investor Relations Contact
Corey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com
+1 212 915 2577Media Relations Contact
Virginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061 ext 1PROTAGONIST THERAPEUTICS, INC.
Consolidated Statements of Operations
(Amounts in thousands except share and per share data) Three Months Ended March 31, 2026 2025 License and collaboration revenue $56,368 $28,321 Operating expense: Research and development (1) 46,739 35,893 General and administrative (1) 13,277 11,738 Total operating expense 60,016 47,631 Loss from operations (3,648) (19,310)Interest income 5,876 7,573 Other income, net 53 82 Income (loss) before income tax benefit 2,281 (11,655)Income tax benefit 1,502 - Net income (loss) $3,783 $(11,655)Net income (loss) per share, basic $0.06 $(0.19)Net income (loss) per share, diluted $0.05 $(0.19)Weighted-average shares used to compute net income (loss) per share, basic 65,087,847 62,963,806 Weighted-average shares used to compute net income (loss) per share, diluted 70,492,618 62,963,806 (1) Amount includes non-cash stock-based compensation expense.Stock-based Compensation
(In thousands) Three Months Ended March 31, 2026 2025 Research and development $7,769 $7,991 General and administrative 6,750 5,811 Total stock-based compensation expense $14,519 $13,802 PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
(In thousands) March 31, December 31, 2026 2025 Cash, cash equivalents and marketable securities$ 620,334 $646,002 Working capital 578,906 532,133 Total assets 697,459 668,188 Deferred revenue 6,282 9,550 Accumulated deficit (466,888) (470,671)Total stockholders' equity 655,473 614,707 SOURCE: Protagonist TherapeuticsView the original press release on ACCESS NewswireOriginal: Protagonist Reports First Quarter 2026 Financial Results and Provides Corporate Update
US Market News
2月前
Protagonist Exercises Rusfertide U.S. Opt-Out Right Under Takeda CollaborationApril 28, 2026 9:05 AM
ACCESS NewswireOpt-out election makes Protagonist eligible for $200 million upon exercise and an additional $200 million upon FDA approval of rusfertide for polycythemia veraApproval would also trigger a $75 million milestone payment, bringing total potential cash tied to the opt-out election and approval to $475 millionProtagonist becomes eligible for up to $975 million in milestone payments and tiered royalties ranging from 14% to 29% on worldwide net salesNEWARK, CA / ACCESS Newswire / April 28, 2026 / Protagonist Therapeutics, Inc. (Nasdaq:PTGX) ("Protagonist" or the "Company") today announced that it has exercised its right to opt out of the 50:50 U.S. profit and loss sharing arrangement under its worldwide license and collaboration agreement with Takeda for rusfertide, an investigational first-in-class hepcidin mimetic peptide under U.S. Food and Drug Administration (FDA) Priority Review for the treatment of adults with polycythemia vera (PV).By exercising its opt-out right during the contractual opt-out period, Protagonist becomes eligible to receive up to $400 million in opt-out payments, consisting of $200 million payable upon the opt-out election and a further $200 million payable upon FDA approval of rusfertide for the treatment of adults with PV. In addition, U.S. approval of rusfertide would trigger a $75 million milestone payment, bringing total potential cash payable in connection with the opt-out election and U.S. approval to $475 million.As a result of the opt-out election, Takeda now holds exclusive development and commercialization rights to rusfertide in the United States, in addition to its existing exclusive ex-U.S. rights. Under the opt-out structure, Protagonist becomes eligible to receive up to $975 million in milestone payments and tiered royalties on worldwide net sales ranging from 14% to 29%, corresponding to a weighted-average royalty rate of approximately 21% at $1.5 billion in annual net sales, with the top royalty tier of 29% applying to annual net sales above $1.5 billion."Exercising our opt-out right reflects our conviction in rusfertide and secures what we believe is the most attractive risk-adjusted value outcome for Protagonist and its shareholders as the hepcidin mimetic peptide approaches a potential approval," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist Therapeutics. "This election provides meaningful near-term non-dilutive cash, materially enhances our long-term economic participation through milestones and worldwide royalties, and further strengthens our ability to invest in our broader pipeline and return value to shareholders. We value our partnership with Takeda and believe they are exceptionally well-positioned to maximize the global opportunity for rusfertide."Rusfertide is under FDA Priority Review for the treatment of adults with PV, with a Prescription Drug User Fee Act (PDUFA) target action date in the third quarter of 2026. Under the parties' January 2024 collaboration agreement, Protagonist received a $300 million upfront payment and retained the right to elect either a 50:50 U.S. profit and loss share or an opt-out structure featuring enhanced payments, milestones, and worldwide royalties.About Rusfertide
Rusfertide is a first-in-class investigational subcutaneous treatment that mimics the action of hepcidin, a natural hormone that regulates iron homeostasis and red blood cell production. By targeting the underlying mechanism of iron dysregulation in polycythemia vera, rusfertide aims to reduce excess red blood cell production and help patients achieve sustained hematocrit control. The molecule demonstrated rapid, stable, and durable control of hematocrit in Phase 2 & 3 studies as part of the clinical development program for PV. Rusfertide was discovered and developed using Protagonist Therapeutics' proprietary peptide technology platform. Rusfertide was previously being co-developed in PV. As a result of the opt-out election, Takeda now holds exclusive development and commercialization rights to rusfertide in the United States, in addition to its existing exclusive ex-U.S. rights. The program has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, underscoring its potential to address significant unmet needs in a chronic hematologic disease with limited modern therapeutic innovation.About Polycythemia Vera (PV)
Polycythemia vera (PV) is characterized by the overproduction of red blood cells (erythrocytosis), which increases blood viscosity, or thickness, that can result in life-threatening thrombotic events such as stroke, deep vein thrombosis, and pulmonary embolism. Hematocrit (HCT) is the ratio of red blood cells to the total amount of blood in the body. Achieving and maintaining controlled HCT levels of
US Market News
3月前
Protagonist Announces Presentation of One-Year Phase 3 Data for ICOTYDE(TM) in Moderate-to-Severe Plaque Psoriasis at the 2026 American Academy of Dermatology (AAD) Annual MeetingMarch 28, 2026 10:05 AM
ACCESS NewswireOne-year Phase 3 data for ICOTYDE to be presented at AAD 2026 demonstrate lasting skin clearance and a favorable safety profile in a once daily pill for moderate-to-severe plaque psoriasisResults further support the differentiated profile of ICOTYDE, the first and only IL-23 receptor targeted oral peptideNEWARK, CA / ACCESS Newswire / March 28, 2026 / Protagonist Therapeutics, Inc. (Nasdaq:PTGX) ("Protagonist" or "the Company") today announced new one-year Phase 3 results for ICOTYDE™ (icotrokinra) were presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting. Data from the Phase 3 ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD studies further support the potential of ICOTYDE as a differentiated oral therapy for patients with moderate-to-severe plaque psoriasis."The one-year Phase 3 results presented at AAD reinforce our belief that ICOTYDE by virtue of having IL-23 antagonist efficacy, a favorable safety profile and the convenience of a once-daily oral pill option, has the potential to meaningfully expand treatment options for people living with moderate-to-severe plaque psoriasis," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist Therapeutics. "These findings highlight the power of Protagonist's peptide discovery platform and our ability to create highly differentiated oral medicines against clinically validated biological pathways."ICOTYDE is the first and only targeted oral peptide designed to precisely block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque PsO.ICOTYDE was developed using Protagonist's proprietary peptide technology platform. The Company continues to invest in its discovery engine and development pipeline, with multiple programs moving towards proof-of-concept trials designed to produce therapeutics with clinically relevant competitive differentiation.Under the license and collaboration agreement established in 2017 between Protagonist and Janssen Biotech, Inc., a Johnson & Johnson company, Johnson & Johnson is responsible for all commercial activities for ICOTYDE. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization.ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2ICOTYDE demonstrated durable rates of complete skin clearance through Week 52 with no new safety signals identified. Rates of PASI 100 increased from Week 24 to Week 52 in the ICOTYDE treatment arms, and patients who switched from placebo to ICOTYDE at Week 16 achieved similar rates of complete skin clearance by Week 52 as those treated with ICOTYDE continuously for 52 weeks. The ICOTYDE adverse event profile through Week 52 was consistent with that observed through Weeks 16 and 24, and no new safety signal was identified through Week 52. ICOTYDE overall adverse event and infection rates were lower than deucravacitinib through Week 24.ICONIC-LEADICOTYDE also demonstrated sustained efficacy and a favorable safety profile in adolescents through Week 52. Nearly 60% of adolescents treated with ICOTYDE achieved completely clear skin at one year, and 86% achieved PASI 90, with 92% maintaining that response from Week 24 to Week 52. No new safety signals were identified over one year of treatment.The pivotal ICONIC Phase 3 clinical development program includes five studies in plaque psoriasis: ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, ICONIC-ADVANCE 2, and ICONIC-ASCEND. Additional studies are also underway in psoriatic arthritis, ulcerative colitis, and Crohn's disease.Under Protagonist's collaboration agreement with Johnson & Johnson, the Company is eligible to receive tiered royalties on net sales of ICOTYDE and additional future milestone payments. Protagonist believes the continued advancement of ICOTYDE highlights the strength of its oral peptide platform and its strategy of creating potentially best-in-class medicines through internal innovation and strategic partnerships.About ICOTYDE™ (icotrokinra)ICOTYDE (icotrokinra) is the first and only targeted oral peptide designed to precisely block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque PsO. ICOTYDE binds to the IL-23 receptor with high affinity and demonstrated potent inhibition of IL-23 signaling in human T cells. Clinical significance of these findings are unknown.ICOTYDE is currently approved in the U.S. for the treatment of adults, and pediatric patients 12 years of age and older who weigh at least 40 kg, with moderate-to-severe plaque PsO who are candidates for systemic therapy or phototherapy. Patients on ICOTYDE take one pill, once a day with water upon waking, 30 minutes prior to eating food.ICOTYDE is also currently in Phase 3 studies for active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease.ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists and is being developed and commercialized by Johnson & Johnson. The approval of ICOTYDE triggers a $50 million milestone payment to Protagonist. Protagonist is also eligible for 6 - 10% upward tiering royalties on worldwide net sales, as well as additional regulatory and sales milestone payments of up to $580 million.About Plaque Psoriasis
Plaque psoriasis (PsO) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful. It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease. Nearly one-quarter of all people with plaque PsO have cases that are considered moderate-to-severe. On Caucasian skin, plaques typically appear as raised, red patches covered with a silvery white buildup of dead skin cells or scale. On skin of color, the plaques may appear darker and thicker, and more of a purple, gray, or dark brown color. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso. Living with plaque PsO can be a challenge and impact life beyond a person's physical health, including emotional health, relationships, and handling the stressors of life. Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life.About ProtagonistProtagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. The Company's proprietary peptide technology platform enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE™ (icotrokinra) is approved in the U.S. for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor (IL-23R) licensed to Janssen Biotech, Inc., a Johnson & Johnson company. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization. An NDA for rusfertide, a first-in-class hepcidin mimetic peptide that is being co-developed with Takeda Pharmaceuticals pursuant to a worldwide license and collaboration agreement entered in 2024, is under priority review with the FDA. Protagonist holds an option to co-commercialize rusfertide in the U.S. through a 50/50 profit and loss share structure or can opt-out of this structure. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com.Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of ICOTYDE and potential revenue from the Company's collaboration with Johnson & Johnson. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.Investor Relations ContactCorey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com
+1 212 915 2577Media Relations ContactVirginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061 ext 1ICOTYDE™ INDICATION AND IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ICOTYDE?Infections. Medicines that interact with the immune system, such as ICOTYDE, may lower your ability to fight infections and may increase your risk of infections. Your healthcare provider may check you for infections and tuberculosis (TB) before starting treatment and may treat you for TB before you begin treatment with ICOTYDE if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with ICOTYDE.Tell your healthcare provider right away if you have any infection or have symptoms of an infection, including: fever, sweat, or chillscoughshortness of breathblood in your mucus (phlegm)muscle acheswarm, red, or painful skin or sores on your body different from your psoriasisweight lossdiarrhea or stomach painburning when you urinate or urinating more often than normalBefore taking ICOTYDE, tell your healthcare provider about all of your medical conditions, including if you:have an infection that does not go away or that keeps coming back.have tuberculosis (TB) or have been in close contact with someone with TB.have recently received or are scheduled to receive an immunization (vaccine). Avoid receiving live vaccines during treatment with ICOTYDE.have kidney problems.are pregnant or plan to become pregnant. It is not known if ICOTYDE can harm your unborn baby.Pregnancy Safety Study. There is a pregnancy safety study for women who take ICOTYDE during pregnancy. The purpose of this study is to collect information about the health of you and your baby. If you are pregnant or become pregnant during treatment with ICOTYDE, you can report your pregnancy by calling 1-800-526-7736 or visiting www.ICOTYDE.com.are breastfeeding or plan to breastfeed. It is not known if ICOTYDE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ICOTYDE.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.What are the possible side effects of ICOTYDE?ICOTYDE may cause serious side effects. See "What is the most important information I should know about ICOTYDE?"The most common side effects of ICOTYDE include:headachenauseacoughfungal infectiontirednessThese are not all the possible side effects of ICOTYDE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.How should I take ICOTYDE?Take ICOTYDE exactly as your healthcare provider tells you to take it.Take ICOTYDE 1 time a day when you wake up on an empty stomach with water. Wait at least 30 minutes after taking ICOTYDE before eating food.If you have difficulty swallowing tablets, ICOTYDE can be dispersed in water. For more information, please read the Medication Guide.If you miss a dose of ICOTYDE, take the dose as soon as you remember and go back to your regular schedule the next day.Please read the full Prescribing Information, including Medication Guide, for ICOTYDE and discuss any questions that you have with your doctor.SOURCE: Protagonist TherapeuticsView the original press release on ACCESS NewswireOriginal: Protagonist Announces Presentation of One-Year Phase 3 Data for ICOTYDE(TM) in Moderate-to-Severe Plaque Psoriasis at the 2026 American Academy of Dermatology (AAD) Annual Meeting
US Market News
3月前
Protagonist Therapeutics Announces U.S. FDA Approval of ICOTYDE(TM) (icotrokinra) for the Treatment of Moderate to Severe Plaque PsoriasisMarch 18, 2026 8:05 AM
ACCESS NewswireICOTYDE is the first and only IL-23R targeted oral peptide that delivers complete skin clearance and a favorable safety profile in a once-daily pillApproval supported by four phase 3 studies that met all primary endpoints and demonstrated a favorable safety profile in 2,500 patients$50 million milestone payment triggered by FDA approval; Protagonist is eligible to receive 6 - 10% royalties on sales and up to $580 million in future milestone paymentsWebcast and conference call to be held at 8:30 am ET on March 18NEWARK, CA / ACCESS Newswire / March 18, 2026 / Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or "the Company") announced today that Johnson & Johnson received U.S. Food and Drug Administration (FDA) approval for ICOTYDE™ (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only targeted oral peptide that precisely blocks the IL-23 receptor.ICOTYDE will be commercialized by Johnson & Johnson under the license and collaboration agreement established in 2017 between Protagonist and Janssen Biotech, Inc., a Johnson & Johnson company. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization.FDA approval of ICOTYDE triggers a $50 million milestone payment to Protagonist. Protagonist is eligible to receive up to $580 million in potential additional regulatory and sales milestone payments, as well as tiered royalties ranging from 6% to 10% on global net sales, corresponding to 7.25% on a weighted-average basis at $4 billion in annual sales, with the top royalty tier of 10% applying to sales above $4 billion."ICOTYDE offers a novel plaque psoriasis treatment that combines the established efficacy and safety of IL-23 pathway blockade with the convenience of a once-daily oral pill. The FDA approval of ICOTYDE reflects a successful culmination of years of groundbreaking research and clinical development that began over 13 years ago in our laboratories and demonstrates the strength of our peptide technology platform to generate innovative therapies," said Dinesh V. Patel, PhD, President and Chief Executive Officer of Protagonist Therapeutics. "I am incredibly proud of our team's dedication and commitment to addressing unmet medical needs and making a meaningful difference in the lives of patients.""I would also like to congratulate Johnson & Johnson for maintaining a productive and seamless collaboration ongoing since 2017 as this novel medicine was advanced from discovery through development and finally to FDA approval," Patel continued. "We look forward to results from ongoing clinical studies evaluating ICOTYDE in additional IL-23-driven diseases, including psoriatic arthritis, ulcerative colitis, and Crohn's disease. With the pending FDA decision for rusfertide this year, and the financial resources for accelerating pipeline investment, we're confident this is the beginning of a multi-year product-driven growth cycle for Protagonist Therapeutics."ICOTYDE was developed using Protagonist's proprietary peptide technology platform. The Company continues to invest in its discovery engine and development pipeline, with multiple programs moving towards proof-of-concept trials designed to produce therapeutics with clinically relevant competitive differentiation.Clinical evidence summary
ICOTYDE met all primary endpoints and demonstrated a favorable safety profile across four Phase 3 studies including 2,500 patients. The approval is based on an unprecedented body of evidence from the ICONIC clinical development program, which simultaneously evaluated ICOTYDE in adults and adolescents, high impact sites such as scalp and genital PsO, and in duplicate head-to-head trials versus an active comparator. In the head-to-head studies, approximately 70% of patients achieved clear or almost clear skin (IGA 0/1) and 55% of patients achieved a Psoriasis Area and Severity Index (PASI)90 response at Week 16. Rates of adverse reactions for ICOTYDE treated patients were within 1.1% of placebo through Week 16 and no new safety signals were identified through Week 52.Additional studies underway in other disease areas include: ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424) in active psoriatic arthritis; ICONIC-UC (NCT071196748) in moderately to severely active ulcerative colitis; and ICONIC-CD (NCT7196722) in moderately to severely active Crohn's disease.Conference Call and Webcast Details
The dial-in numbers for Protagonist's investor update on March 18th at 8:30 am ET are:
US-based Investors: 1-877-407-0752
International Investors: 1-201-389-0912
Conference Call ID: 13759426The webcast link for the event can be found here:
https://viavid.webcasts.com/starthere.jsp?ei=1756753&tp_key=f99979a28eA replay will be available on the Company's Investor Relations Events and Presentations webpage following the event.Unmet need in moderate to severe plaque psoriasis
Psoriasis affects more than eight million Americans, impacting physical comfort and quality of life, especially when lesions are on visible or sensitive areas. For many with moderate to severe disease, targeted systemic treatments are key. This aligns with International Psoriasis Council guidance to transition to systemic therapy if two cycles of topical medications applied for four weeks fail to bring meaningful improvement.About ICOTYDE™ (icotrokinra)
ICOTYDE is the first and only targeted oral peptide designed to precisely block the IL-23 receptor, which underpins the inflammatory response in moderate to severe plaque PsO. ICOTYDE binds to the IL-23 receptor with high affinity and demonstrated potent inhibition of IL-23 signaling in human T cells. Clinical significance of these findings are unknown.ICOTYDE is currently approved in the U.S. for the treatment of adults, and pediatric patients 12 years of age and older who weigh at least 40 kg, with moderate to severe plaque PsO who are candidates for systemic therapy or phototherapy. Patients on ICOTYDE take one pill, once a day with water upon waking, 30 minutes prior to eating food.ICOTYDE is also currently in Phase 3 studies for active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease.FullICOTYDE™ prescribing information will be available on the ICOTYDE™ website.About Plaque Psoriasis
Plaque psoriasis (PsO) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful. It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease. Nearly one-quarter of all people with plaque PsO have cases that are considered moderate to severe. On Caucasian skin, plaques typically appear as raised, red patches covered with a silvery white buildup of dead skin cells or scale. On skin of color, the plaques may appear darker and thicker, and more of a purple, gray, or dark brown color. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso. Living with plaque PsO can be a challenge and impact life beyond a person's physical health, including emotional health, relationships, and handling the stressors of life. Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life.About Protagonist
Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. The Company's proprietary peptide technology platform enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE™ (icotrokinra) is approved in the U.S. for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor (IL-23R) licensed to Janssen Biotech, Inc.,a Johnson & Johnson company. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization. An NDA for rusfertide, a first-in-class hepcidin mimetic peptide that is being co-developed with Takeda Pharmaceuticals pursuant to a worldwide license and collaboration agreement entered in 2024, is under priority review with the FDA. Protagonist holds an option to co-commercialize rusfertide in the U.S. through a 50/50 profit and loss share structure or can opt-out of this structure. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com.Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of ICOTYDE and potential revenue from the Company's collaboration with Johnson & Johnson. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.Investor Relations Contact
Corey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com
+1 212 915 2577Media Relations Contact
Virginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061 ext 1SOURCE: Protagonist TherapeuticsView the original press release on ACCESS NewswireOriginal: Protagonist Therapeutics Announces U.S. FDA Approval of ICOTYDE(TM) (icotrokinra) for the Treatment of Moderate to Severe Plaque Psoriasis
US Market News
4月前
CORRECTION: Protagonist Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate UpdateFebruary 25, 2026 5:15 PM
ACCESS Newswire(This release updates the release that posted earlier on February 25, 2026 to update the sub headlines.)NDA for rusfertide submitted to the US Food and Drug Administration (FDA), with potential approval and launch this yearCompany expects to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda during a 90-day window expected to open in Q2U.S. regulatory decision for ICOTYDETM (icotrokinra) anticipated in 2026 with potential launch this yearPN-881 Phase 1 completion expected by mid-2026Pre-clinical pipeline expanded with novel wholly-owned candidates PN-477, an oral and s.c. triple GLP-GIP-GCG agonist and PN-458, an oral and s.c. dual GLP-GIP agonist, and PN-8047, an oral hepcidin functional mimeticCash, cash equivalents and marketable securities of $646 million as of December 31, 2025, anticipated to provide cash runway through at least end of 2028NEWARK, CA / ACCESS Newswire / February 25, 2026 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a corporate update."In 2025, Protagonist reached new heights with multiple successful Phase 3 outcomes and two NDA filings of our partnered assets, ICOTYDE and rusfertide," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "We see the next 12 to 24 months as a period of significant growth and value creation for Protagonist, driven by a combination of the anticipated regulatory and commercial milestones and royalties from ICOTYDE and rusfertide and the continued advancement of our robust R&D pipeline comprised of the oral IL-17 peptide antagonist, our obesity dual and triple agonists, and our oral hepcidin functional mimetic. We are well equipped to fund all our internal wholly owned programs to clinical proof-of-concept with the cash on hand and potential revenue from the partnered assets."Fourth Quarter 2025 Recent Developments and Upcoming MilestonesRusfertideUnder the terms of its License and Collaboration Agreement with Takeda Pharmaceuticals USA, Inc., Protagonist has the right to opt out of the 50:50 profit and loss sharing arrangement in the U.S. during the 90-day period beginning 120 days after filing of a New Drug Application with the FDA for Rusfertide for polycythemia vera. We currently expect to exercise that right in the second quarter of 2026.ICOTYDETM (Icotrokinra)A U.S. regulatory decision is anticipated in 2026, followed by commercial launch this year, if FDA approval is granted.Primary endpoint enrollment completion is expected in 2026 for:The Phase 3 ICONIC-ASCEND multicenter, randomized, double-blind, placebo-controlled, and ustekinumab active comparator-controlled study to evaluate the efficacy and safety of icotrokinra for the treatment of participants with moderate to severe plaque psoriasis (NCT06934226).The Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of icotrokinra for the treatment of biologic-naïve participants with active psoriatic arthritis (NCT06878404).Clinical ProgramsThe Company expects its Phase 1 study of PN-881 to be complete by mid-2026, informing subsequent clinical development plans.Discovery ProgramsRecently, Protagonist announced two new wholly owned development candidates:PN-458, a novel dual GLP-GIP agonist for obesity, andPN-8047, an oral hepcidin functional mimetic complementing rusfertide, an injectable hepcidin mimetic.Additionally, the Company added IL-4Ra and amylin as high-priority discovery programs to further expand and strengthen its pipeline.Fourth Quarter and Full Year 2025 Financial ResultsCash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and marketable securities as of December 31, 2025, were $646.0 million as compared to $559.2 million in the previous year. Revenue: License and collaboration revenue is derived from the Company's License and Collaboration Agreement with JNJ, (the "JNJ Agreement"), and its License and Collaboration Agreement with Takeda (the "Takeda Agreement").License and collaboration revenue decreased by $163.2 million from $170.6 million for the fourth quarter of 2024 to $7.4 million for the fourth quarter of 2025. License and collaboration revenue decreased by $388.4 million from $434.4 million for the full year 2024 to $46.0 million for the full year 2025. The decrease in revenue was primarily attributable to lower milestone and collaboration revenue, which is highly variable and dependent upon factors such as the timing of when regulatory and sales milestones are achieved, if at all, and the accounting for any upfront payments associated with any existing or new agreements.License and collaboration revenue of $7.4 million for the fourth quarter of 2025 was comprised of development services we provided during the period under the Takeda Agreement. License and collaboration revenue of $170.6 million for the fourth quarter of 2024 included (i) achievement of a non-refundable $165.0 milestone under the JNJ Agreement, and (ii) development services we provided during the period under the Takeda Agreement.License and collaboration revenue of $46.0 million for the full year 2025 was comprised of (i) proportional recognition of a $25.0 million milestone earned from Takeda in Q1 25, and (ii) development services we provided during the period under the Takeda agreement. License and collaboration revenue of $434.4 million for the full year 2024 included (i) $254.1 million of the $300.0 million initial transaction price for the Takeda Agreement allocated to the rusfertide license upon effectiveness of the agreement, (ii) achievement of a non-refundable $165.0 milestone under the JNJ Agreement earned in Q4 24, and (iii) development services we provided during the period under the Takeda Agreement.Research and Development Expenses: Increased by $11.5 million and $21.2 million for the fourth quarter and full year 2025, respectively, from the prior year periods. The increases were due primarily to increases in drug discovery and pre-clinical research expenses, including expenses related to our IL-17 product candidate PN-881 and our obesity product candidates.General and Administrative Expenses: Increased by $2.5 million for the three months ended December 31, 2025, from the prior year period primarily due to increases in professional services and personnel-related expenses. The increase of $1.4 million for the full year 2025 as compared to the prior year was primarily due to increases in professional services and personnel-related expenses, partially offset by $4.6 million in one-time advisory and legal fees in 2024 related to the Takeda Agreement.Net (Loss) Income: Net loss was $44.4 million, or $0.69 per basic share and diluted share, for the fourth quarter of 2025 as compared to net income of $131.7 million, or $2.11 per basic share and $1.98 per diluted share, for the fourth quarter of 2024. Net loss was $130.1 million, or $2.05 per basic share and diluted share, for the full year 2025, as compared to net income of $275.2 million, or $4.47 per basic share and $4.23 per diluted share, for the full year 2024.About Protagonist
Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with a New Drug Application (NDA) for ICOTYDETM (icotrokinra) under review at the FDA and an NDA for rusfertide submitted in December 2025. ICOTYDE is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R"), which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following ICOTYDE's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for the development of ICOTYDE through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in development for the rare blood disorder polycythemia vera. Rusfertide is being co-developed and may be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement under which the Company was primarily responsible for development through NDA filing. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets, including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com/.Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding potential timing of regulatory actions, clinical trial results, and potential revenue from the Company's collaborations with Takeda and Johnson & Johnson. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.Investor Relations ContactCorey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com
+1 212 915 2577Media Relations ContactVirginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061 ext 1PROTAGONIST THERAPEUTICS, INC.
Consolidated Statements of Operations
(Amounts in thousands except share and per share data) Three Months Ended Twelve Months Ended December 31, December 31, 2025 2024 2025 2024 License and collaboration revenue $7,437 $170,638 $46,016 $434,433 Operating expense: Research and development (1) 46,358 34,904 159,290 138,128 General and administrative (1) 11,434 8,954 44,853 43,462 Total operating expense 57,792 43,858 204,143 181,590 Loss (income) from operations (50,355) 126,780 (158,127) 252,843 Interest income 6,761 6,853 28,789 26,315 Other (expense) income, net (124) 31 27 250 (Loss) income before income tax expense (43,718) 133,664 (129,311) 279,408 Income tax expense 666 1,990 838 4,220 Net (loss) income $(44,384) $131,674 $(130,149) $275,188 Net (loss) income per share, basic $(0.69) $2.11 $(2.05) $4.47 Net (loss) income per share, diluted $(0.69) $1.98 $(2.05) $4.23 Weighted-average shares used to compute net (loss) income per share, basic 64,031,592 62,328,468 63,573,048 61,566,989 Weighted-average shares used to compute net (loss) income per share, diluted 64,031,592 66,406,817 63,573,048 65,077,722 (1) Amount includes non-cash stock-based compensation expense.Stock-based Compensation
(In thousands) Three Months Ended Twelve Months Ended December 31, December 31, 2025 2024 2025 2024 Research and development $6,121 $5,322 $26,422 $20,919 General and administrative 4,580 3,771 19,552 16,635 Total stock-based compensation expense $10,701 $9,093 $45,974 $37,554 PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
(In thousands) December 31, December 31, 2025 2024 Cash, cash equivalents and marketable securities $646,002 $559,165 Working capital 532,133 544,243 Total assets 668,188 744,725 Deferred revenue 9,550 30,567 Accumulated deficit (470,671) (340,522)Total stockholders' equity 614,707 675,295 SOURCE: Protagonist TherapeuticsView the original press release on ACCESS NewswireOriginal: CORRECTION: Protagonist Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
US Market News
4月前
Protagonist Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate UpdateFebruary 25, 2026 4:05 PM
ACCESS NewswireNDA for rusfertide submitted to the US Food and Drug Administration (FDA), with potential approval and launch this yearCompany expects to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda during a 90-day window expected to open in Q2U.S. regulatory decision for ICOTYDETM (icotrokinra) anticipated in 2026 with
potential launch this yearPN-881 Phase 1 completion expected by mid-2026NEWARK, CALIFORNIA / ACCESS Newswire / February 25, 2026 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a corporate update."In 2025, Protagonist reached new heights with multiple successful Phase 3 outcomes and two NDA filings of our partnered assets, ICOTYDE and rusfertide," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "We see the next 12 to 24 months as a period of significant growth and value creation for Protagonist, driven by a combination of the anticipated regulatory and commercial milestones and royalties from ICOTYDE and rusfertide and the continued advancement of our robust R&D pipeline comprised of the oral IL-17 peptide antagonist, our obesity dual and triple agonists, and our oral hepcidin functional mimetic. We are well equipped to fund all our internal wholly owned programs to clinical proof-of-concept with the cash on hand and potential revenue from the partnered assets."Fourth Quarter 2025 Recent Developments and Upcoming MilestonesRusfertideUnder the terms of its License and Collaboration Agreement with Takeda Pharmaceuticals USA, Inc., Protagonist has the right to opt out of the 50:50 profit and loss sharing arrangement in the U.S. during the 90-day period beginning 120 days after filing of a New Drug Application with the FDA for Rusfertide for polycythemia vera. We currently expect to exercise that right in the second quarter of 2026.ICOTYDETM (Icotrokinra)A U.S. regulatory decision is anticipated in 2026, followed by commercial launch this year, if FDA approval is granted.Primary endpoint enrollment completion is expected in 2026 for:The Phase 3 ICONIC-ASCEND multicenter, randomized, double-blind, placebo-controlled, and ustekinumab active comparator-controlled study to evaluate the efficacy and safety of icotrokinra for the treatment of participants with moderate to severe plaque psoriasis (NCT06934226).The Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of icotrokinra for the treatment of biologic-naïve participants with active psoriatic arthritis (NCT06878404).Clinical ProgramsThe Company expects its Phase 1 study of PN-881 to be complete by mid-2026, informing subsequent clinical development plans.Discovery ProgramsRecently, Protagonist announced two new wholly owned development candidates:PN-458, a novel dual GLP-GIP agonist for obesity, andPN-8047, an oral hepcidin functional mimetic complementing rusfertide, an injectable hepcidin mimetic.Additionally, the Company added IL-4Ra and amylin as high-priority discovery programs to further expand and strengthen its pipeline.Fourth Quarter and Full Year 2025 Financial ResultsCash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and marketable securities as of December 31, 2025, were $646.0 million as compared to $559.2 million in the previous year. Revenue: License and collaboration revenue is derived from the Company's License and Collaboration Agreement with JNJ, (the "JNJ Agreement"), and its License and Collaboration Agreement with Takeda (the "Takeda Agreement").License and collaboration revenue decreased by $163.2 million from $170.6 million for the fourth quarter of 2024 to $7.4 million for the fourth quarter of 2025. License and collaboration revenue decreased by $388.4 million from $434.4 million for the full year 2024 to $46.0 million for the full year 2025. The decrease in revenue was primarily attributable to lower milestone and collaboration revenue, which is highly variable and dependent upon factors such as the timing of when regulatory and sales milestones are achieved, if at all, and the accounting for any upfront payments associated with any existing or new agreements.License and collaboration revenue of $7.4 million for the fourth quarter of 2025 was comprised of development services we provided during the period under the Takeda Agreement. License and collaboration revenue of $170.6 million for the fourth quarter of 2024 included (i) achievement of a non-refundable $165.0 milestone under the JNJ Agreement, and (ii) development services we provided during the period under the Takeda Agreement.License and collaboration revenue of $46.0 million for the full year 2025 was comprised of (i) proportional recognition of a $25.0 million milestone earned from Takeda in Q1 25, and (ii) development services we provided during the period under the Takeda agreement. License and collaboration revenue of $434.4 million for the full year 2024 included (i) $254.1 million of the $300.0 million initial transaction price for the Takeda Agreement allocated to the rusfertide license upon effectiveness of the agreement, (ii) achievement of a non-refundable $165.0 milestone under the JNJ Agreement earned in Q4 24, and (iii) development services we provided during the period under the Takeda Agreement.Research and Development Expenses: Increased by $11.5 million and $21.2 million for the fourth quarter and full year 2025, respectively, from the prior year periods. The increases were due primarily to increases in drug discovery and pre-clinical research expenses, including expenses related to our IL-17 product candidate PN-881 and our obesity product candidates.General and Administrative Expenses: Increased by $2.5 million for the three months ended December 31, 2025, from the prior year period primarily due to increases in professional services and personnel-related expenses. The increase of $1.4 million for the full year 2025 as compared to the prior year was primarily due to increases in professional services and personnel-related expenses, partially offset by $4.6 million in one-time advisory and legal fees in 2024 related to the Takeda Agreement.Net (Loss) Income: Net loss was $44.4 million, or $0.69 per basic share and diluted share, for the fourth quarter of 2025 as compared to net income of $131.7 million, or $2.11 per basic share and $1.98 per diluted share, for the fourth quarter of 2024. Net loss was $130.1 million, or $2.05 per basic share and diluted share, for the full year 2025, as compared to net income of $275.2 million, or $4.47 per basic share and $4.23 per diluted share, for the full year 2024.About Protagonist
Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with a New Drug Application (NDA) for ICOTYDETM (icotrokinra) under review at the FDA and an NDA for rusfertide submitted in December 2025. ICOTYDE is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R"), which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following ICOTYDE's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for the development of ICOTYDE through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in development for the rare blood disorder polycythemia vera. Rusfertide is being co-developed and may be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement under which the Company was primarily responsible for development through NDA filing. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets, including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com/.Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding potential timing of regulatory actions, clinical trial results, and potential revenue from the Company's collaborations with Takeda and Johnson & Johnson. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.Investor Relations ContactCorey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com
+1 212 915 2577Media Relations ContactVirginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061 ext 1PROTAGONIST THERAPEUTICS, INC.
Consolidated Statements of Operations
(Amounts in thousands except share and per share data) Three Months Ended Twelve Months Ended December 31, December 31, 2025 2024 2025 2024 License and collaboration revenue $ 7,437 $ 170,638 $ 46,016 $ 434,433 Operating expense: Research and development (1) 46,358 34,904 159,290 138,128 General and administrative (1) 11,434 8,954 44,853 43,462 Total operating expense 57,792 43,858 204,143 181,590 Loss (income) from operations (50,355) 126,780 (158,127) 252,843 Interest income 6,761 6,853 28,789 26,315 Other (expense) income, net (124) 31 27 250 (Loss) income before income tax expense (43,718) 133,664 (129,311) 279,408 Income tax expense 666 1,990 838 4,220 Net (loss) income $ (44,384) $ 131,674 $ (130,149) $ 275,188 Net (loss) income per share, basic $ (0.69) $ 2.11 $ (2.05) $ 4.47 Net (loss) income per share, diluted $ (0.69) $ 1.98 $ (2.05) $ 4.23 Weighted-average shares used to compute net (loss) income per share, basic 64,031,592 62,328,468 63,573,048 61,566,989 Weighted-average shares used to compute net (loss) income per share, diluted 64,031,592 66,406,817 63,573,048 65,077,722 (1) Amount includes non-cash stock-based compensation expense.Stock-based Compensation
(In thousands) Three Months Ended Twelve Months Ended December 31, December 31, 2025 2024 2025 2024 Research and development $6,121 $5,322 $26,422 $20,919 General and administrative 4,580 3,771 19,552 16,635 Total stock-based compensation expense $10,701 $9,093 $45,974 $37,554 PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
(In thousands) December 31, December 31, 2025 2024 Cash, cash equivalents and marketable securities $646,002 $559,165 Working capital 532,133 544,243 Total assets 668,188 744,725 Deferred revenue 9,550 30,567 Accumulated deficit (470,671) (340,522)Total stockholders' equity 614,707 675,295 SOURCE: Protagonist TherapeuticsView the original press release on ACCESS NewswireOriginal: Protagonist Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
US Market News
4月前
Protagonist Therapeutics to Participate in Multiple Investment Bank Conferences in March 2026February 24, 2026 7:30 AM
ACCESS NewswireNEWARK, CA / ACCESS Newswire / February 24, 2026 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced that Dinesh V. Patel, Ph.D., President and Chief Executive Officer, will participate in multiple investment bank conferences taking place in March 2026.TD Cowen 46th Annual Health Care Conference; Boston, MA - March 2-4, 2026
Format: Fireside Chat
Day/Time: Tuesday, March 3 at 11:50 A.M. ET
Webcast: https://event.summitcast.com/view/9z5g2VrV6e6rbCqQgDRoHA/6QuKhqDYvNSrPH8co9v5gdLeerink Global Healthcare Conference; Miami, FL - March 8-11, 2026
Format: Fireside Chat
Day/Time: Monday, March 9 at 4:20 P.M. ET
Webcast: https://event.summitcast.com/view/mT9poctHDNthc6b89WqVjf/K8FdPptAY5cyfndeY9RPP9Jefferies Biotech on the Beach Summit; Miami, FL - March 10-11, 2026
Format: One-on-one Meetings
Day/Time: Tuesday, March 10Citizens Life Sciences Conference; Miami, FL - March 10-11, 2026
Format: Fireside Chat
Day/Time: Wednesday, March 11 at 1:05 P.M. ET
Webcast: https://event.summitcast.com/view/BuMiPNPtyHKimMF6k4AFMd/UWj58vHDxUk6PseGJr4ebsBarclays 28th Annual Global Healthcare Conference; Miami, FL - March 10-12, 2026
Format: Fireside Chat
Day/Time: Thursday, March 12 at 11:30 A.M. ET
Webcast: https://cc.webcasts.com/barc002/031026a_js/?entity=30_ESKWJT8If you are interested in meeting with the Protagonist team during the conferences, please reach out to your respective conference representative.A replay of the presentations will be available on the Company's Investor Relations Events and Presentations webpage for one year following the event.About Protagonist
Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with a New Drug Application (NDA) for icotrokinra submitted to the FDA in July, and an NDA for rusfertide submitted in December 2025. Icotrokinra (formerly, JNJ-2113), is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R"), which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following icotrokinra's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for the development of icotrokinra through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets, including IL-17 oral peptide antagonist PN-881, obesity triple agonist peptide PN-477, and the oral hepcidin program.More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com.Investor Relations Contact
Corey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.comMedia Contact
Virginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.comSOURCE: Protagonist TherapeuticsView the original press release on ACCESS NewswireOriginal: Protagonist Therapeutics to Participate in Multiple Investment Bank Conferences in March 2026
ziggy7796
4年前
Pulled from yahoo finance...this stock could explode 4x if phase 3 does well...cheers ziggy
?
Protagonist Therapeutics Announces Topline Data from Phase 2 IDEAL Study of PN-943 in Ulcerative Colitis
April 25, 2022, 4:25 pm
PN-943 achieved 27.5% clinical remission with a delta of 13% versus placebo, with strong concordance across all key proxies including histological and endoscopic endpoints for efficacy, in the twice daily 150 mg dose arm
Achieved clinical proof-of-concept and validation for oral, gut-restricted approach for ulcerative colitis via blockade of the alpha-4-beta-7-integrin pathway
Plans underway for a registrational Phase 3 study anchored around twice daily 150 mg dose of PN-943, pending regulatory guidance
Protagonist to host a conference call today at 6:00 p.m. ET
NEWARK, Calif., April 25, 2022 /PRNewswire/ -- Protagonist Therapeutics (Nasdaq: PTGX) today announced topline results from the Phase 2 IDEAL study evaluating PN-943 in patients with moderate-to-severe ulcerative colitis (UC).
"We are delighted with the strength of the results from the IDEAL study and look forward to working with the regulatory agencies as we prepare for a Phase 3 registrational program for PN-943 in moderate-to-severe ulcerative colitis," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist. "Our oral, gut-restricted alpha-4-beta-7-integrin antagonist agent PN-943 has demonstrated clinical efficacy on par with the approved injectable antibody drug working through the same biological target. We believe the results of the IDEAL study may be paradigm shifting and of broad scientific relevance in understanding IBD pathogenesis and gut-restricted drug development via intervention of the integrin-MAdCAM pathway. Based on its convenience of oral administration and the favorable efficacy and safety results observed to date, we believe that PN-943 has the potential to become a first-in-class, foundational oral medicine for individuals living with moderate-to-severe ulcerative colitis."
"With the IDEAL study, we have demonstrated clinical proof-of-concept and validation for potential treatment of ulcerative colitis via oral, gut-restricted blockade of the alpha-4-beta-7-integrin pathway," said Scott Plevy, M.D., Executive Vice President and Therapeutic Head of Gastroenterology at Protagonist. "The study assessed two doses of PN-943, 150 mg BID and 450 mg BID, and demonstrated a very clear and consistent treatment effect at the lower 150 mg BID dose across key endpoints. The dose response demonstrated by this study is consistent with several other modalities in the integrin pathway. The findings in the lower-dose arm provide consistent evidence of clinical efficacy and safety, and clear direction on the dosing regimen for the Phase 3 registrational program."
"The oral, gut-restricted agent PN-943 appears to exert similar effects at the twice daily 150 mg dose in comparison to the approved injectable alpha-4-beta-7-integrin antibody drug and its mechanism of action," said Bruce Sands, M.D., M.S., the Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine at Mount Sinai, principal investigator for the IDEAL study and consultant to Protagonist. "There is a clear unmet need and strong clinical benefit for patients with an oral agent working through such a proven IBD specific mechanism, and the IDEAL study results provide good rationale for moving PN-943 forward in a Phase 3 registrational study."
Summary of Key Results
IDEAL is a randomized, double-blinded, placebo-controlled, multicenter Phase 2 study to evaluate the safety and efficacy of PN-943, an oral, gut-restricted, alpha-4-beta-7-integrin antagonist. 159 patients with moderate-to-severe active UC were randomized to either twice daily (BID) with 450 mg or 150 mg PN-943, or placebo, for 12 weeks and analyzed for outcome measures.
While the 450 mg BID dose did not meet the prespecified primary endpoint, the 150 mg dose achieved a placebo versus treatment delta of 13% (p=0.08) in the modified Intent to Treat (mITT) group, and a delta of 16% (p=0.04) in the bio-naïve group. In addition, the 150 mg BID data showed strong concordance across multiple parameters including statistically significant histological remission and endoscopic improvement.
PN-943 150 mg BID dose forms the basis for a Phase 3 registrational program
27.5% clinical remission vs 14.5% in placebo (delta 13%, p=0.08) for mITT analysis
Strong concordance with efficacy across multiple key secondary endpoints with statistically significant differences in histologic remission/improvement and endoscopic improvement
Safety analysis similar for the 150 mg BID dose versus the placebo group
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