Protagonist reports MIMRYLO FDA approval, Q3 2026 results, PN-881 Phase 2b plan
FDA approval of MIMRYLO triggered $275 million in payments to Protagonist, and the company plans a Phase 2b psoriasis study of PN-881 for early Q1 2027.
Protagonist Therapeutics reported third quarter 2026 results on November 5, 2026. The company's partner Takeda received FDA approval on August 28 of MIMRYLO (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera.1 MIMRYLO is described as the first and only hepcidin mimetic peptide therapy approved for this indication.1 The drug was also approved in the United Arab Emirates on September 30, 2026.1
The FDA approval triggered $275 million in payments to Protagonist: a $200 million opt-out payment plus a $75 million approval milestone.1 Under an opt-out election Protagonist made in April 2026, Takeda now holds exclusive worldwide rights to develop and commercialize MIMRYLO, while Protagonist keeps tiered royalties of 14% to 29% of net sales (about 21% weighted average at $1.5 billion in annual sales) and is eligible for up to $875 million more in milestones.1 Pivotal Phase 3 VERIFY study results were published in the Journal of Clinical Oncology on October 13, 2026.1
On the ICOTYDE (icotrokinra) program with Johnson & Johnson, the drug received regulatory approvals in China, Japan and the European Union during the quarter, following U.S. approval in March 2026.1 Phase 2 ANTHEM-UC results were published in the New England Journal of Medicine on October 14, 2026.1 Johnson & Johnson also presented two-year Phase 3 data from the ICONIC-TOTAL and ICONIC-LEAD studies in September and October 2026, showing sustained responses through Week 112 in plaque psoriasis patients.1
For wholly owned programs, the Phase 1 study of PN-881, an oral IL-17 antagonist, has been completed, with trough drug levels exceeding target thresholds and no serious adverse events, and the company plans to start a Phase 2b dose-finding study in plaque psoriasis in early Q1 2027.1 Positive Phase 1 results for the subcutaneous obesity candidate PN-477sc led the company to prioritize an oral version, PN-477o, with a Phase 1 study expected in the first half of 2027.1
On September 8, Protagonist's board authorized a share repurchase program of up to $300 million.1 As of September 30, 2026, cash, cash equivalents and marketable securities totaled $834.6 million, up from $646.0 million at the end of 2025.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.