Protagonist Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
Core Insights - Protagonist Therapeutics has submitted a New Drug Application (NDA) for rusfertide to the US FDA, with potential approval and launch expected within the year [1] - The company plans to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda during a 90-day window anticipated to open in Q2 [1] - A regulatory decision for ICOTYDETM (icotrokinra) is expected in 2026, with a potential launch also anticipated this year [1] - Completion of Phase 1 for PN-881 is expected by mid-2026 [1] - In 2025, Protagonist achieved significant milestones with multiple successful Phase 3 outcomes and two NDA filings for partnered assets, ICOTYDE and rusfertide [1]