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Protagonist Therapeutics develops peptide-based therapeutics using a proprietary discovery platform, with programs spanning inflammation and immunology, hematology and metabolic disease. Company news centers on ICOTYDE™ (icotrokinra), an oral IL-23 receptor-targeted peptide approved for moderate-to-severe plaque psoriasis, and rusfertide, a hepcidin mimetic peptide for polycythemia vera developed with Takeda.
Recurring updates also cover collaboration economics with Johnson & Johnson's Janssen Biotech and Takeda, clinical and regulatory milestones, R&D spending on wholly owned discovery programs, financial results, investor conference participation and equity-based inducement awards under Nasdaq rules.
Protagonist (Nasdaq:PTGX) reported Q4 and full-year 2025 results and a corporate update on Feb 25, 2026. Cash and marketable securities were $646.0M at year-end. The company submitted an NDA for rusfertide, expects a U.S. opt-out decision window in Q2 2026, and anticipates a 2026 U.S. decision and potential launch for ICOTYDE.
License and collaboration revenue fell to $46.0M for 2025 from $434.4M in 2024; net loss was $130.1M for 2025. PN-881 Phase 1 is expected complete by mid-2026.
Protagonist Therapeutics (NASDAQ: PTGX) announced CEO Dinesh V. Patel will participate in multiple investment bank conferences in March 2026. Events include TD Cowen (Boston, Mar 2-4), Leerink (Miami, Mar 8-11), Jefferies and Citizens (Miami, Mar 10-11), and Barclays (Miami, Mar 10-12).
Live webcasts and replays will be available; investors can request meetings via conference representatives. Replays will be posted on the company's investor relations page for one year following each event.
Protagonist Therapeutics (NASDAQ:PTGX) announced that Dinesh V. Patel, Ph.D., President and CEO will present a company overview at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026 at 8:15 AM PST.
The company will hold one-on-one investor meetings during the conference. A live webcast is available at the provided J.P. Morgan link, and a replay will be posted on Protagonist's Investor Relations Events and Presentations webpage for one year following the event. Investors seeking meetings should contact their J.P. Morgan representative.
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.
Takeda (NYSE:TAK) and Protagonist presented 52-week VERIFY and four-year THRIVE data showing durable hematocrit control with rusfertide in polycythemia vera (PV).
Key results: 61.9% of patients on rusfertide maintained absence of phlebotomy eligibility through Week 52; 77.9% of placebo-to-rusfertide crossovers achieved response at Weeks 40–52; mean hematocrit stayed 43% through Week 52. Long‑term data showed a >13‑fold reduction in annual phlebotomy rate (from 9.2 to 0.7 phlebotomies/year). Rusfertide was generally well tolerated with mostly grade 1–2 events.
Protagenic Therapeutics (Nasdaq:PTGX) received a Nasdaq non-compliance notice dated November 27, 2025, citing failure to meet Listing Rule 5550(b)(1) (minimum $2.5 million stockholders' equity) and Rule 5250(c)(1) (timely periodic filings).
Nasdaq concluded the Company's Transition Report on Form 10-QT for the period ended June 30, 2025 showed stockholders' equity below the $2.5 million threshold, and the delayed Form 10-Q for the quarter ended September 30, 2025 is a separate basis for non-compliance. Under Rule 5815 the Staff issued a delisting determination. The Company expects to file the Form 10-Q imminently and will request a hearing and an automatic 15-calendar-day stay, and may request an extended stay pending the Panel decision.
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.