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Gossamer Bio Shares Climb After Filing First-Ever FDA Drug Application for Seralutinib
Gossamer Bio Inc. (NASDAQ:GOSS) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for its drug candidate seralutinib, marking the company's first-ever regulatory submission for a new medicine. The company's shares rose 3.7% in after-hours trading Wednesday following the announcement.
Application Details
The NDA seeks approval for seralutinib as a treatment for pulmonary arterial hypertension (PAH), a serious condition affecting blood vessels in the lungs. Gossamer Bio's submission is supported by clinical data from its Phase 3 PROSERA Study and the Phase 2 TORREY Study, along with other supportive analyses, the company stated.
This filing represents a significant milestone for Gossamer Bio, a clinical-stage biopharmaceutical firm focused on developing seralutinib for PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
AdRegulatory Path Forward
The submission follows a Pre-NDA Type B meeting with the FDA held in June 2026. According to Gossamer Bio, the FDA's official minutes from that meeting characterized the statistical significance and treatment effect observed in the PROSERA study as review issues rather than filing issues. This distinction suggests the application is considered complete enough for submission, though these aspects will be subject to scrutiny during the formal review process.
The next step is for the FDA to decide whether to accept the NDA for filing and substantive review. Gossamer Bio anticipates this decision could be made later this year. The agency's ultimate determination on the drug's efficacy and safety will occur during its comprehensive review of the complete application.
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