Gossamer Bio Inc.
09/23/2026 | Press release | Distributed by Public on 09/23/2026 14:06
Material Event (Form 8-K)
Item 8.01 Other Events.
On September 23, 2026, Gossamer Bio, Inc. (the "Company") announced that it submitted a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") in September 2026 for seralutinib for the treatment of pulmonary arterial hypertension ("PAH"). This is the Company's first NDA submission.
The NDA is supported by the Company's Phase 3 PROSERA Study as one adequate and well-controlled clinical investigation, together with confirmatory evidence from the Company's Phase 2 TORREY Study and supportive analyses. The NDA submission follows the Company's Pre-NDA Type B meeting with the FDA in June 2026 and the FDA's official written meeting minutes, in which the FDA characterized the degree of statistical significance and the magnitude of the treatment effect observed in PROSERA as review issues rather than filing issues, and provided feedback on the format and content of the planned submission.
The FDA will determine whether to accept the NDA for filing following its initial review of the application, which the Company anticipates could occur later this year. The acceptability of the individual elements of the application, including the efficacy and safety evidence, would be determined by the FDA during its substantive review of the complete NDA.
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