FDA confirmed review issues for seralutinib's NDA in PAH, supporting a September 2026 submission and potential Q3 2027 approval. Worldwide rights were reacquired, debt was reduced, and launch readiness will resume, with ex-U.S. filings planned. PH-ILD is a key future indication.Based on Gossamer Bi…
FDA confirmed review issues for seralutinib's NDA in PAH, supporting a September 2026 submission and potential Q3 2027 approval. Worldwide rights were reacquired, debt was reduced, and launch readiness will resume, with plans for global filings and a strong focus on PAH-ILD as a future indication.B…
A planned NDA submission for seralutinib in PAH is set for September 2026, following positive FDA feedback. Worldwide rights to seralutinib were reacquired, consolidating global control and simplifying economics. Financial flexibility improved through a convertible note exchange and reverse stock s…
