ACCESS Newswire·Feb 25, 2026, 4:05 PM ET

Protagonist Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

PTGX

Protagonist Therapeutics submitted a New Drug Application (NDA) for rusfertide to the FDA with potential approval and launch expected in 2026.
The company plans to exercise its right to opt-out of the 50:50 profit and loss sharing arrangement with Takeda for rusfertide during a 90-day window opening in Q2 2026.
A U.S. regulatory decision for ICOTYDE (icotrokinra) is anticipated in 2026, with a potential commercial launch this year if approved.
Primary endpoint enrollment completion for two Phase 3 studies of ICOTYDE in psoriasis is expected in 2026.
Completion of the Phase 1 study for PN-881 is projected by mid-2026.
Two new wholly owned development candidates were announced: PN-458 (a dual GLP-GIP agonist for obesity) and PN-8047 (an oral hepcidin functional mimetic).
The company added IL-4Rα and amylin to its high-priority discovery programs.
Cash, cash equivalents, and marketable securities totaled $646.0 million as of December 31, 2025, up from $559.2 million in the prior year.
License and collaboration revenue dropped to $7.4 million for Q4 2025 from $170.6 million in Q4 2024, primarily due to the absence of major milestone payments in the current period.
Full-year license and collaboration revenue was $46.0 million in 2025 compared to $434.4 million in 2024.
Research and development expenses increased by $11.5 million in Q4 2025 and $21.2 million for the full year 2025 compared to the prior year.
General and administrative expenses rose by $2.5 million in Q4 2025 and $1.4 million for the full year 2025, driven by personnel and professional service costs.
The company reported a net loss of $44.4 million ($0.69 per share) for Q4 2025, contrasting with a net income of $131.7 million in the same period last year.
Full-year 2025 net loss was $130.1 million ($2.05 per share), compared to a net income of $275.2 million in 2024.