Gossamer Bio Files New Drug Application with U.S. FDA for Seralutinib
核心洞察
Gossamer Bio submitted a New Drug Application to the U.S. FDA in September 2026 for seralutinib in pulmonary arterial hypertension (搜索), the company's first NDA submission.
The filing rests on the Phase 3 PROSERA study as one adequate and well-controlled investigation, with confirmatory evidence from the Phase 2 TORREY study and supportive analyses.
FDA meeting minutes from a June 2026 Pre-NDA Type B meeting characterized PROSERA's statistical significance and treatment effect magnitude as review issues rather than filing issues.
Gossamer Bio has submitted a New Drug Application to the U.S. Food and Drug Administration (搜索) for seralutinib for the treatment of pulmonary arterial hypertension (搜索) (PAH). The submission was made in September 2026 and is the company's first NDA filing.
The application is supported by the Phase 3 PROSERA study as one adequate and well-controlled clinical investigation, together with confirmatory evidence from the Phase 2 TORREY study and supportive analyses. The submission follows a Pre-NDA Type B meeting with the FDA in June 2026 and the agency's written meeting minutes, in which the FDA characterized the degree of statistical significance and the magnitude of the treatment effect seen in PROSERA as review issues rather than filing issues, and gave feedback on the format and content of the planned submission.
The FDA will decide whether to accept the NDA for filing after its initial review, which Gossamer expects could occur later this year. The company notes that acceptability of the individual elements of the application, including the efficacy and safety evidence, will be determined by the FDA during review of the complete NDA. Gossamer is developing seralutinib for PAH and for pulmonary hypertension associated with interstitial lung disease (搜索).
Source: Morningstar