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

This is an AI-generated summary and may contain inaccuracies. Please verify any important information with the original source.