Protagonist Therapeutics Announces U.S. FDA Approval of ICOTYDE(TM) (icotrokinra) for the Treatment of Moderate to Severe Plaque Psoriasis Protagonist Therapeutics (NASDAQ:PTGX) announced U.S. FDA approval of ICOTYDE (icotrokinra) for moderate-to-severe plaque psoriasis in adults and patients 12+ weighing ≥40 kg. Approval followed four Phase 3 studies (2,500 patients) showing high efficacy and favorable safety. Johnson & Johnson will commercialize ICOTYDE.Approval triggers a $50 million milestone to Protagonist; the company is eligible for 6–10% royalties and up to $580 million additional milestones. A webcast and call are scheduled for March 18 at 8:30 am ET.

#PTGX Protagonist Therapeutics Announces U.S. FDA Approval of ICOTYDE(TM) (icotrokinra) for the Treatment of Moderate to Severe Plaque Psoriasis

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Takeda and Protagonist Announce Submission of New Drug Application (NDA) for Rusfertide for Treatment of Polycythemia Vera (PV) Takeda (NYSE:TAK) and Protagonist announced submission of a New Drug Application (NDA) to the FDA on January 5, 2026 seeking approval of rusfertide for adults with polycythemia vera (PV). The NDA includes 52-week data from the Phase 3 VERIFY study, which met the primary endpoint and all four key secondary endpoints, showing durable hematocrit control, reduced phlebotomy needs and improved patient-reported outcomes.Rusfertide is a first-in-class subcutaneous hepcidin mimetic and has received Breakthrough Therapy, Orphan Drug and Fast Track designations. Under the January 2024 collaboration, the NDA filing starts a 120-day period then a 90-day opt-out decision window for Protagonist, with up to $400 million in opt-out payments and 14–29% tiered royalties possible.

#TAK #PTGX Takeda and Protagonist Announce Submission of New Drug Application (NDA) for Rusfertide for Treatment of Polycythemia Vera (PV)

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Protagonist and Takeda Present Longer-Term Data at ASH 2025 Showing Rusfertide Delivers Durable Response and Hematocrit Control in Polycythemia Vera 52- Week Results from the Phase 3 VERIFY Study of Rusfertide Demonstrated Sustained Hematocrit Control and Response, Defined by Absence of Phlebotomy Eligibility, with No New Safety Signals These Data Build on Positive 32- Week Primary Analysis from VERIFY, Which Met its Primary Efficacy Endpoint and All Four Key Secondary Endpoints Patients Crossing...

#TAK #PTGX Protagonist and Takeda Present Longer-Term Data at ASH 2025 Showing Rusfertide Delivers Durable Response and Hematocrit Control in Polycythemia Vera

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#PTGX Protagonist Reports Third Quarter 2025 Financial Results and Provides Corporate Update

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Protagonist Announces New Icotrokinra Data in Ulcerative Colitis and Plaque Psoriasis Presented at Two Recent Medical Conferences Icotrokinra demonstrated clinically meaningful outcomes at Week 28 in the Phase 2b ANTHEM-UC study in ulcerative colitis, with 31.7% of patients achieving clinical remission and 38.1% showing endoscopic improvement versus placeboUpdated ANTHEM-UC data support Phase 3 clinical development of

#PTGX Protagonist Announces New Icotrokinra Data in Ulcerative Colitis and Plaque Psoriasis Presented at Two Recent Medical Conferences

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📊 #Ottava #Immunology #AtopicDermatitis #Markets #Investing

#ISRG #JNJ #Healthcare #Pharma #Biotech #TechnicalAnalysis #DividendKings #FreeCashFlow #MergersAndAcquisitions #ISRG #PTGX #Ottava #Immunology #AtopicDermatitis #Markets #Investing (10/10)

📊 rather than thesis changers.
- Cross-asset read-throughs: Ottava milestones are a relative risk for #ISRG; any PTGX update could ripple across mid-cap immunology.

Hashtags: #JNJ #Healthcare #Pharma #Biotech #TechnicalAnalysis #DividendKings #FreeCashFlow #MergersAndAcquisitions #ISRG #PTGX (9/10)

JUST IN: ( NASDAQ: #PTGX ) Why Protagonist Therapeutics Stock Skyrocketed by Almost 30% Today

First Oral IL-23 Blocker Shows Superior Results: Protagonist's Icotrokinra Aims to Transform Psoriasis Care Novel once-daily oral peptide demonstrates superior efficacy vs deucravacitinib in Phase 3 trials, with 49.1% AE rate. Treats adults and adolescents 12+ with moderate-severe plaque psoriasis.

#PTGX Protagonist Announces Icotrokinra Application for Approval in Plaque Psoriasis Submitted to the European Medicines Agency

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Breakthrough Status: Protagonist's Novel Blood Disorder Drug Shows Practice-Changing Potential in Phase 3 Rusfertide granted FDA Breakthrough Therapy Designation for polycythemia vera treatment, following positive Phase 3 VERIFY trial results. NDA submission planned for Q4 2025.

#PTGX Rusfertide Receives Breakthrough Therapy Designation for Treatment of Erythrocytosis in Patients with Polycythemia Vera

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Protagonist Announces Submission of NDA for First Icotrokinra U.S. FDA Approval Aiming to Revolutionize Treatment Paradigm for Adults and Adolescents with Plaque Psoriasis Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptorFiling based on unprecedented data package that met all primary endpoints across four Phase 3 studies, including head-to-head superiority comparisons versus deucravacitinib and evaluation

#PTGX Protagonist Announces Submission of NDA for First Icotrokinra U.S. FDA Approval Aiming to Revolutionize Treatment Paradigm for Adults and Adolescents with Plaque Psoriasis

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Protagonist Announces Nomination of PN-477, an Oral and Injectable GLP-1R, GIPR, and GCGR Triple Agonist Peptide Development Candidate for Obesity Protagonist Therapeutics (NASDAQ:PTGX) has announced the nomination of PN-477, a novel GLP-1, GIP, and GCG receptor triple agonist peptide, as a development candidate for obesity treatment. The drug candidate features both oral (PN-477o) and injectable (PN-477sc) formulations, designed for once-daily and once-weekly administration respectively.The company reports that PN-477 has demonstrated potent in vitro activity in activating all three targeted receptors and has shown robust preclinical proof-of-concept in various animal studies, including diet-induced obesity mouse models, normal dogs, and cynomolgus monkeys. The candidate is engineered to be orally stable with balanced potencies against the three receptors to potentially maximize weight loss benefits while minimizing adverse effects.Protagonist has initiated IND-enabling studies and expects to begin Phase 1 clinical trials in the second quarter of 2026. The company positions PN-477 as a potential best-in-class treatment option, aiming to offer weight loss comparable to the best injectable treatments while providing the flexibility of both oral and injectable administration routes.

#PTGX Protagonist Announces Nomination of PN-477, an Oral and Injectable GLP-1R, GIPR, and GCGR Triple Agonist Peptide Development Candidate for Obesity

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Protagonist and Takeda Report Positive Phase 3 Results in Rare Blood Cancer at ASCO 2025 VERIFY study meets all endpoints in polycythemia vera, supporting improved hematocrit control, reduced need for phlebotomy, and symptom relief Protagonist Th

#PTGX and #TAK report positive Phase 3 results for rusfertide in rare blood cancer PV at ASCO 2025! The data shows major progress in symptom control and disease management.
#ProtagonistTx #TakedaPharma
#Biotech #ProtagonistTherapeutics #RareDisease #PVResearch
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Protagonist Hits Major Clinical Win: Phase 3 Trial Success Sets Stage for Two FDA Filings in 2025 Breakthrough Phase 3 VERIFY trial results lead Q1 highlights, with $698M cash runway through 2028. Two potential drug approvals ahead. See full trial data.

#PTGX Protagonist Reports First Quarter 2025 Financial Results and Provides Corporate Update

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Icotrokinra Results Show 75% of Adolescents with Plaque Psoriasis Achieved Completely Clear Skin and Demonstrate Favorable Safety Profile with a Once Daily Pill Protagonist Therapeutics announced promising Phase 3 trial results for icotrokinra, a first-in-class oral peptide targeting IL-23 receptor for moderate-to-severe plaque psoriasis. The ICONIC-LEAD study's adolescent cohort showed remarkable efficacy at Week 16, with 84.1% achieving clear/almost clear skin (IGA 0/1) and 70.5% reaching PASI 90, compared to 27.3% and 13.6% in placebo group respectively.Results improved further by Week 24, with 75% of adolescents achieving completely clear skin (IGA 0) and 63.6% reaching PASI 100. The safety profile was favorable, with fewer adverse events in the treatment group (50%) compared to placebo (73%). This marks the first Phase 3 study evaluating a systemic therapy simultaneously in both adolescents and adults with plaque psoriasis.

#PTGX Icotrokinra Results Show 75% of Adolescents with Plaque Psoriasis Achieved Completely Clear Skin and Demonstrate Favorable Safety Profile with a Once Daily Pill

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Breaking News: ( NASDAQ: #PTGX ) Protagonist Reports Positive Top Line Results From Phase 2b Study of Icotrokinra Showing Potential to Transform the Treatment Paradigm for Patients With Ulcerative Colitis

Icotrokinra Clinical Study Results Demonstrate Its Potential to Shift Treatment Paradigm and Set a New Standard for Treatment in Plaque Psoriasis Protagonist Therapeutics announced breakthrough results for icotrokinra (JNJ-2113), a first-in-class oral peptide for moderate-to-severe plaque psoriasis (PsO). In the Phase 3 ICONIC-LEAD study, the once-daily pill demonstrated remarkable efficacy with 46% of patients achieving completely clear skin (IGA 0) at Week 24.Key findings at Week 24 showed 74% of patients achieved clear/almost clear skin (IGA 0/1) and 65% reached PASI 90. The drug demonstrated a favorable safety profile, with adverse events comparable to placebo (49% in both groups).Additionally, in the ICONIC-ADVANCE 1&2 studies, icotrokinra showed superiority to deucravacitinib, meeting all primary and secondary endpoints. Based on these positive results, a groundbreaking head-to-head study (ICONIC-ASCEND) will compare icotrokinra against injectable biologic ustekinumab, potentially establishing a new standard in PsO treatment.

#PTGX Icotrokinra Clinical Study Results Demonstrate Its Potential to Shift Treatment Paradigm and Set a New Standard for Treatment in Plaque Psoriasis

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Protagonist and Takeda Announce Positive Topline Results from Phase 3 VERIFY Study of Rusfertide in Patients with Polycythemia Vera Protagonist Therapeutics (NASDAQ:PTGX) and Takeda (TSE:4502/NYSE:TAK) announced positive topline results from their Phase 3 VERIFY study of rusfertide in polycythemia vera (PV) patients. The study achieved its primary endpoint with 77% of rusfertide-treated patients showing clinical response compared to 33% in the placebo group.The trial met all four key secondary endpoints, including the EU primary endpoint showing 0.5 phlebotomies per patient in the rusfertide arm versus 1.8 in the placebo arm. Rusfertide, a first-in-class hepcidin mimetic peptide therapeutic with FDA Orphan Drug and Fast Track designations, demonstrated favorable safety with mainly grade 1-2 injection site reactions.Following these positive results, Protagonist will receive a $25 million milestone payment from Takeda upon completion of the VERIFY clinical study report.

#TAK #PTGX Protagonist and Takeda Announce Positive Topline Results from Phase 3 VERIFY Study of Rusfertide in Patients with Polycythemia Vera

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From Losses to $275M Profit: How Protagonist Therapeutics Transformed in 2024 Protagonist achieves profitability with $434M revenue and $559M cash position. Key clinical readouts for rusfertide and icotrokinra expected March 2025.

#PTGX Protagonist Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

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Protagonist's Rusfertide Shows Breakthrough Results in Phase 2 PV Study: 54% Hit Key Treatment Goals Final data reveals strong efficacy in polycythemia vera treatment, with patients maintaining hematocrit control and reduced phlebotomy needs over 2.5 years in Phase 2 REVIVE study.

#PTGX Protagonist Reports Final Results From Rusfertide Phase 2 REVIVE Study Showing Durable Hematocrit Control at the ASH 2024 Annual Meeting

#StockMarket #investing #news

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NEWS: ( NASDAQ: #PTGX ) Protagonist Therapeutics to Participate in the 7th Annual Evercore ISI HealthCONx Conference 2024

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#PTGX Protagonist Announces Nomination of PN-881, a Potential Best-in-Class Oral Peptide IL-17 Antagonist Development Candidate

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#PTGX Protagonist Therapeutics to Host Conference Call to Announce an Oral Peptide IL-17 Antagonist Development Candidate

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