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 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 Therapeutics (PTGX) will present four abstracts on rusfertide in polycythemia vera at the 2026 European Hematology Association Congress in Stockholm, June 11-14, 2026.
Data span the Phase 3 VERIFY trial and long-term Phase 2 REVIVE and THRIVE extension studies, covering efficacy, safety, cytoreductive therapy use, thromboembolic and progression events, and patient-reported outcomes.
Protagonist Therapeutics (Nasdaq:PTGX) announced that President and CEO Dinesh V. Patel, Ph.D., will participate in two June 2026 healthcare investment conferences.
He will join fireside chats at the Jefferies Global Healthcare Conference in New York on June 3 at 9:55 A.M. ET and the Goldman Sachs 47th Annual Global Healthcare Conference in Miami on June 10 at 9:20 A.M. ET, both accessible via webcast. Replay of the presentations will be available on the company’s investor relations website for one year.
Protagonist (Nasdaq:PTGX) reported Q1 2026 results and a corporate update, highlighting FDA approval of ICOTYDE, a $50.0 million milestone payment, and FDA Priority Review for rusfertide with a PDUFA date in Q3 2026. The company exercised a $200.0 million rusfertide opt-out fee and expects increased downstream economics, including up to $775.0 million in sales milestones and 14%–29% royalties. Cash, cash equivalents and marketable securities were $620.3 million as of March 31, 2026, projected to fund operations through at least 2028. PN-881 and PN-477 clinical progress continues.
Protagonist (Nasdaq:PTGX) exercised its U.S. opt-out right under the Takeda collaboration for rusfertide, making Protagonist eligible for $200 million upon election and another $200 million upon FDA approval.
U.S. approval would add a $75 million milestone, bringing opt-out-linked cash to $475 million, and the company remains eligible for up to $975 million in milestones plus tiered worldwide royalties of 14%–29% (weighted-average ~21% at $1.5B sales). PDUFA target action is Q3 2026.
Protagonist Therapeutics (Nasdaq:PTGX) granted inducement awards on April 15, 2026 to two newly hired employees under its Amended and Restated Inducement Plan.
The awards total options for 55,425 shares and RSUs for 14,425 shares; option exercise price is $105.44, equal to the April 15, 2026 closing price. Vesting spans four years. Awards were approved by the compensation committee and granted in accordance with Nasdaq Rule 5635(c)(4).
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.