Gossamer Bio, Inc., a clinical-stage biopharmaceutical company, focuses on developing and commercializing seralutinib for the treatment of pulmonary hypertension and pulmonary arterial hypertension in the United States. The company develops GB002, an inhaled, small molecule, platelet-derived growth factor receptor, or PDGFR, colony-stimulatin factor 1 receptor and c-KIT inhibitor, which is in Phase 3 clinical trial for the treatment of PAH. It has license agreements with Pulmokine, Inc. to develop and commercialize GB002 and related backup compounds. The company was formerly known as FSG, Bio, Inc. and changed its name to Gossamer Bio, Inc. in 2017. The company was incorporated in 2015 and is headquartered in San Diego, California.
Gossamer Bio Submits New Drug Application to U.S. FDA for Seralutinib for the Treatment of Pulmonary Arterial Hypertension
Gossamer Bio submitted its first NDA to the FDA in September 2026 for seralutinib to treat pulmonary arterial hypertension.
The filing relies on the Phase 3 PROSERA study plus confirmatory evidence from the Phase 2 TORREY study; the FDA's June 2026 Pre-NDA meeting minutes characterized the degree of statistical significance and magnitude of treatment effect as review issues rather than filing issues.
The FDA is expected to decide on filing acceptance later this year, but approval risk remains given the review-stage questions flagged and the company's dependence entirely on seralutinib's success.