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News about Protagonist Therapeutics, Inc. (NASDAQ: PTGX) centers on its progress as a discovery-through-late-stage development biopharmaceutical company advancing peptide-based drug candidates. Company announcements frequently highlight clinical and regulatory milestones for its lead investigational therapies, icotrokinra and rusfertide, as well as updates from its broader pipeline and collaborations.
Investors following PTGX news will see regular coverage of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor. Press releases describe data from Phase 3 ICONIC studies in moderate-to-severe plaque psoriasis, including ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and 2, as well as the Phase 2b ANTHEM-UC trial in ulcerative colitis. News items also report on regulatory submissions, such as the New Drug Application to the U.S. FDA and an application to the European Medicines Agency for plaque psoriasis.
Coverage of rusfertide focuses on its development for polycythemia vera in collaboration with Takeda. News releases describe Phase 3 VERIFY study results, long-term extension data from THRIVE, and the submission of a New Drug Application to the FDA for adults with polycythemia vera. These updates often include details on hematocrit control, phlebotomy requirements, patient-reported outcomes, and regulatory designations such as Breakthrough Therapy, Orphan Drug, and Fast Track status.
Additional PTGX news includes presentations at major medical and scientific conferences, such as the American Society of Hematology Annual Meeting, European Academy of Dermatology and Venereology Congress, American College of Gastroenterology meeting, and the J.P. Morgan Healthcare Conference. The company also issues periodic financial result and corporate update releases, which summarize recent clinical achievements, collaboration developments with Johnson & Johnson and Takeda, and progress in earlier-stage programs like PN-881, PN-477, and the oral hepcidin initiative.
For readers tracking PTGX, this news stream provides insight into Protagonist’s clinical data, regulatory interactions, partnership activities, and pipeline evolution as described in its own public communications.
Protagonist (Nasdaq:PTGX) reported one-year Phase 3 results for ICOTYDE in moderate-to-severe plaque psoriasis presented at AAD 2026 showing durable complete skin clearance, a favorable safety profile, and oral once-daily dosing. Adolescents: ~60% PASI100, 86% PASI90; 92% maintained PASI90 from Week 24 to 52.
ICOTYDE demonstrated increased PASI100 from Week 24 to Week 52, no new safety signals through Week 52, and lower overall adverse event and infection rates versus deucravacitinib through Week 24. J&J holds commercialization rights; Protagonist may receive tiered royalties and milestone payments.
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.
Takeda (NYSE:TAK) and Protagonist announced the FDA accepted the NDA for rusfertide and granted Priority Review with a PDUFA target action date in the third quarter of this calendar year. Rusfertide is a first-in-class hepcidin mimetic for adults with polycythemia vera.
The NDA was based on Phase 3 VERIFY primary and 52-week results plus four-year Phase 2 REVIVE/THRIVE data showing improved hematocrit control, reduced phlebotomy needs, higher clinical response rates versus standard of care, and generally tolerable safety.
Protagonist (Nasdaq:PTGX) reported Q4 and full‑year 2025 results and provided a corporate update. Key items: NDA for rusfertide submitted to the FDA with potential 2026 approval and launch, expected opt‑out of the U.S. 50:50 profit‑share with Takeda in Q2 2026, and U.S. decision for ICOTYDE anticipated in 2026.
Financials: $646.0M cash and marketable securities at Dec 31, 2025, revenue fell to $46.0M FY 2025, and net loss was $130.1M for FY 2025.
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.