India, July 27 -- Gossamer Bio, Inc. (GOSS) announced that following a productive Pre-NDA Type B meeting with the U.S. FDA and receipt of the official meeting minutes, the company is moving forward with a planned NDA submission for Seralutinib in pulmonary arterial hypertension in September 2026.
If accepted for filing, Seralutinib could be eligible for an FDA approval decision in the third quarter of 2027.
Pulmonary arterial hypertension (PAH) is a rare, progressive disease that causes high blood pressure in the lungs, leading to shortness of breath, fatigue, and heart failure. Current therapies often slow progression but do not fully address the unmet need for patients living with this condition.
Seralutinib is an investigational, inha...