Gossamer Bio Submits NDA To FDA For Seralutinib For Treatment Of Pulmonary Arterial Hypertension

Gossamer Bio, Inc. has submitted its first New Drug Application (NDA) to the FDA for seralutinib, aimed at treating pulmonary arterial hypertension (PAH). The NDA is supported by data from the Phase 3 PROSERA Study and the Phase 2 TORREY Study, following a Pre-NDA Type B meeting with the FDA in June 2026. The FDA is expected to conduct an initial review of the NDA later this year to determine its acceptability for filing.