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Protagonist Reports Third Quarter 2026 Financial Results and Provides Corporate Update

PTGX
  • Protagonist Therapeutics reported a net income of $220.0 million for Q3 2026, driven by FDA approval of MIMRYLO™ which triggered $275 million in payments to the company.
  • MIMRYLO™ (rusfertide) received FDA approval for treating erythrocytosis in adults with polycythemia vera, representing the first approval of a hepcidin mimetic for this indication.
  • The $275 million payment from MIMRYLO™ approval consists of a $200 million opt-out fee and a $75 million milestone, with the company eligible for up to $875 million in future milestones.
  • ICOTYDE® (icotrokinra) secured regulatory approvals in China, Japan, and the European Union following its U.S. FDA approval in March 2026.
  • Protagonist announced a $300 million share repurchase program in September 2026 to be funded by cash reserves and royalties from collaboration partners.
  • The company holds $834.6 million in cash, cash equivalents, and marketable securities as of September 30, 2026.
  • A comprehensive Phase 2b program for PN-881, an oral IL-17 antagonist for psoriasis, is planned to initiate in early Q1 2027.
  • Clinical development for oral PN-477o (obesity) is anticipated to begin in the first half of 2027, prioritized over the subcutaneous formulation.
  • License \& collaboration revenue totaled $274.4 million for Q3 2026, primarily driven by proportional recognition of payments from Takeda.
  • Net income for the nine months ended September 30, 2026, was $386.6 million, contrasting with a net loss of $85.8 million in the same period of 2025.
  • R\&D expenses increased to $41.3 million in Q3 2026 due to advancement of clinical programs \& headcount, while G\&A expenses rose to $13.7 million.
  • Takeda holds exclusive worldwide rights to MIMRYLO™ following Protagonist's April 2026 opt-out election, with royalties ranging from 14% to 29%.
  • Johnson \& Johnson commercializes ICOTYDE® with Protagonist receiving tiered royalties from 6% to 10% on global net sales.
  • Phase 3 VERIFY study results for MIMRYLO™ were published in the Journal of Clinical Oncology on October 13, 2026.
  • Phase 2 ANTHEM-UC study results for ICOTYDE® were published in the New England Journal of Medicine on October 14, 2026.
  • ICOTYDE® is in development for additional indications including psoriatic arthritis, ulcerative colitis, \& Crohn's disease.
  • PN-8047, an oral hepcidin functional mimetic for PV, is expected to initiate Phase 1 studies in Q1 2027.