Gossamer Bio submits FDA NDA for seralutinib in pulmonary arterial hypertension
GOSS•Regulatory timeline
The FDA is expected to decide on acceptance for filing later this year.
FDA filing for seralutinib
Gossamer Bio submitted a New Drug Application to the FDA in September 2026 for seralutinib to treat pulmonary arterial hypertension.
The filing is backed by the Phase 3 PROSERA study, with confirmatory evidence from the Phase 2 TORREY study.
