Gossamer Bio Submits First New Drug Application to FDA for Seralutinib

Gossamer Bio announced it has submitted its first New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its drug candidate, seralutinib, for the treatment of pulmonary arterial hypertension (PAH).

Key Details

• Drug and Indication: The NDA is for seralutinib as a potential treatment for pulmonary arterial hypertension (PAH).
• Supporting Data: The submission is supported by data from the Phase 3 PROSERA Study and the Phase 2 TORREY Study.
• Regulatory Milestone: This is the company's first NDA submission, following a Pre-NDA meeting with the FDA in June 2026. The FDA will now review the application to determine whether to accept it for filing.