Welcome to our dedicated page for Protagonist Ther news (Ticker: PTGX), a resource for investors and traders seeking the latest updates and insights on Protagonist Ther stock.
Protagonist Therapeutics (PTGX) is a clinical-stage biopharmaceutical leader developing oral peptide therapies for inflammatory and hematologic conditions. This news hub provides investors and researchers with essential updates on clinical trials, regulatory milestones, and strategic partnerships.
Access timely announcements about PTGX's innovative constrained peptide platform and pipeline candidates like icotrokinra (IL-23 antagonist) and rusfertide (hepcidin mimetic). Our curated collection includes press releases on trial results, FDA communications, and collaborations with industry leaders including Johnson & Johnson.
Key updates cover therapeutic advancements for psoriasis, ulcerative colitis, and polycythemia vera. Bookmark this page to monitor Protagonist's progress in transforming biologic-like treatments into oral formulations while maintaining competitive positioning through proprietary drug discovery methods.
Protagonist (Nasdaq:PTGX) reported Q3 2025 results and provided program updates on November 6, 2025. Cash, cash equivalents and marketable securities were $678.8M as of September 30, 2025, expected to fund operations through at least end of 2028.
Key development milestones: NDA (July) and EMA (Sept) submissions for icotrokinra in moderate-to-severe plaque psoriasis; rusfertide granted FDA Breakthrough Therapy designation with a Takeda NDA expected in Q4 2025 and 52-week VERIFY data to be presented at ASH in December; first subject dosed in Phase 1 for oral IL-17 antagonist PN-881; PN-477sc and PN-477o progressing IND-enabling with clinical starts expected in 2026; oral hepcidin candidate nomination expected by year-end.
Protagonist Therapeutics (NASDAQ:PTGX) will present clinical data on rusfertide at the 67th ASH Annual Meeting in Orlando, Dec 6-9, 2025.
Four presentations highlight the Phase 3 VERIFY randomized study (durability of response and safety through week 52; patient-reported outcomes; dermatologic observations) and initial results from the Phase 2 THRIVE extension study on long-term rusfertide treatment.
Presentation dates range Dec 6–8, 2025, with authors from Moffitt, Princess Margaret, OHSU, and MD Anderson.
Protagonist (NASDAQ:PTGX) reported updated clinical data for icotrokinra presented October 2025 showing sustained benefit across ulcerative colitis and plaque psoriasis studies. In Phase 2b ANTHEM-UC, icotrokinra 400 mg QD produced 31.7% clinical remission and 38.1% endoscopic improvement at Week 28 versus placebo 9.5% and 11.1%, respectively. Results support Phase 3 ICONIC-UC and Phase 2b/3 ICONIC-CD protocols initiated by Johnson & Johnson. In Phase 3 ICONIC-TOTAL, site-specific psoriasis clearance was high and durable: 72% scalp ss-IGA 0/1, 85% genital sPGA-G 0/1, and overall 67% IGA 0/1 maintained through Week 52, with similar safety profiles through Week 52 versus Week 16.
Protagonist (NASDAQ:PTGX) reported additional Week 12 data from the Phase 2b ANTHEM-UC study of oral icotrokinra, a selective IL-23 receptor blocker, in moderately to severely active ulcerative colitis.
Key Week 12 highlights: the study met its primary endpoint with all once-daily dose groups showing clinical response; the 400 mg dose achieved a 63.5% clinical response vs 27% placebo. At the highest dose, 36.5% showed endoscopic improvement and 30.2% achieved clinical remission. Adverse event rates were similar to placebo through Week 12. Registrational Phase 3 UC and Phase 2b/3 Crohn's studies are anticipated to begin patient enrollment in Q4 2025; an NDA for plaque psoriasis was submitted in July 2025.
Protagonist Therapeutics (NASDAQ:PTGX) presented significant clinical data for two key products at the EADV 2025 Congress. Their lead candidate icotrokinra, a first-in-class oral peptide targeting IL-23 receptor, demonstrated superior efficacy compared to deucravacitinib in Phase 3 ICONIC-ADVANCE studies for plaque psoriasis. The drug showed sustained skin clearance through Week 52 in both adults and adolescents in the ICONIC-LEAD study.
Additionally, the company presented preclinical data for PN-881, their novel oral IL-17 pathway targeting peptide, which showed promising potency and efficacy. PN-881 demonstrated in vitro potency comparable to bimekizumab and 70-fold superior potency to secukinumab. A Phase 1 clinical trial for PN-881 is expected to begin dosing in the coming weeks.
Protagonist Therapeutics (NASDAQ:PTGX) announced an upcoming presentation of Phase 2b ANTHEM-UC trial data for icotrokinra in ulcerative colitis at the United European Gastroenterology Week (UEGW) 2025 in Berlin. The presentation will focus on the 12-week results of this randomized, double-blind, placebo-controlled study.
Dr. Maria Abreu from Cedars-Sinai Medical Center will present findings on this targeted oral peptide that selectively blocks IL-23 receptor activation in moderately to severely active ulcerative colitis. The presentation is scheduled for October 7, 2025, at 3:06 PM CET in the Helsinki Room during the Advanced Therapies in Ulcerative Colitis session.
Protagonist Therapeutics (NASDAQ:PTGX) has announced the submission of an application to the European Medicines Agency (EMA) for icotrokinra, a groundbreaking oral peptide treatment for moderate-to-severe plaque psoriasis. The application is supported by data from four Phase 3 clinical trials that successfully met all primary and co-primary endpoints.
The submission includes comprehensive data demonstrating icotrokinra's efficacy in both adults and adolescents aged 12 and older. Notable achievements include superior results compared to deucravacitinib, successful treatment of difficult-to-treat areas, and a favorable safety profile with adverse events comparable to placebo (49.1% vs 51.9%). The drug offers the convenience of a once-daily tablet while providing significant skin clearance benefits.
Protagonist Therapeutics (NASDAQ:PTGX) announced its participation in three major investment conferences in September 2025. CEO Dinesh V. Patel, Ph.D., will attend Citi's 2025 Biopharma Back to School Summit (September 2-3), H.C. Wainwright 27th Annual Global Investment Conference (September 8-10), and BofA 11th Annual World Medical Innovation Forum (September 15-17).
The CEO will participate in fireside chats at Citi's and H.C. Wainwright's events, scheduled for September 3 and September 9, respectively. At BofA's forum, he will join a panel discussion on "Immunology: Creating the next blockbuster in I&I" on September 16. Webcasts will be available for replay on the company's Investor Relations webpage.
Protagonist Therapeutics (PTGX) announced that its drug rusfertide received Breakthrough Therapy Designation from the FDA for treating erythrocytosis in polycythemia vera (PV) patients. This designation complements the drug's existing Orphan Drug and Fast Track designations, potentially expediting its development and review process.
The designation was supported by positive 32-week data from the Phase 3 VERIFY study, presented at the 2025 ASCO Annual Meeting. The company remains on track for a New Drug Application (NDA) submission in Q4 2025. Rusfertide demonstrated positive results across all primary and secondary endpoints, including hematocrit control and decreased phlebotomy dependence. The drug is being co-developed with Takeda Pharmaceuticals under a worldwide collaboration agreement from 2024.
[ "Received FDA Breakthrough Therapy Designation, adding to existing Orphan Drug and Fast Track designations", "Positive Phase 3 VERIFY trial results across all primary and secondary endpoints", "Strategic partnership with Takeda Pharmaceuticals for worldwide development", "On track for NDA submission in Q4 2025" ]Protagonist Therapeutics (NASDAQ:PTGX) reported Q2 2025 financial results and significant pipeline progress. The company submitted an NDA for icotrokinra to treat psoriasis and plans to present Phase 2b ANTHEM trial data in ulcerative colitis at UEGW. Their Phase 3 VERIFY trial data for rusfertide in polycythemia vera was presented at ASCO, with NDA filing expected in Q4.
Financial highlights include $673.0 million in cash and equivalents (vs $559.2M in Dec 2024), providing runway through 2028. Q2 revenue was $5.5 million, with a net loss of $34.8 million ($0.55 per share). R&D expenses increased to $37.0 million, while G&A expenses rose to $10.6 million.
The company also advanced its pipeline with PN-477, a triple agonist anti-obesity peptide, and PN-881, an oral IL-17 peptide antagonist showing promising preclinical results.
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