Rusfertide - (REVIVE)

August 5, 2026: Protagonist Therapeutics (NASDAQ: PTGX) provided a catalyst update across multiple programs. Rusfertide, a subcutaneous hepcidin mimetic for polycythemia vera, has an NDA under FDA Priority Review with a PDUFA goal date in August 2026. The company said the FDA accepted the NDA in Q1 2026; rusfertide also has Breakthrough Therapy, Orphan Drug, and Fast Track designations. Protagonist highlighted four rusfertide presentations at the 2026 EHA Congress, including Phase 3 VERIFY patient-reported outcomes and long-term efficacy/safety data from REVIVE and THRIVE.

ICOTYDE (icotrokinra), an oral IL-23 receptor antagonist, received U.S. FDA approval on March 18, 2026 for moderate-to-severe plaque psoriasis in adults and pediatric patients age 12+ weighing at least 40 kg who are candidates for systemic therapy or phototherapy. Q2 2026 was its first full quarter of commercial sales.

For wholly owned pipeline programs: PN-881, an oral IL-17 antagonist for psoriasis, is planned to enter a comprehensive Phase 2b program in early Q1 2027 after Phase 1 PK showed 24-hour trough levels above targeted IC90 values with once-daily oral dosing. PN-477sc, a triple GLP1/GIP/GCG agonist for obesity, has entered Phase 1; an oral PN-477 Phase 1 is planned for 1H 2027. PN-8047 Phase 1 is targeted for Q1 2027, and PN-458o Phase 1 for 2H 2027.