Seralutinib (GB002) - (TORREY/PROSERA)

September 2026: Gossamer Bio (NASDAQ: GOSS) said it submitted an NDA to the FDA for seralutinib for pulmonary arterial hypertension (PAH), its first NDA submission. The filing is supported by the Phase 3 PROSERA study as one adequate and well-controlled clinical investigation, plus confirmatory evidence from the Phase 2 TORREY study and additional supportive analyses.

The company said the submission followed a June 2026 Pre-NDA Type B meeting with the FDA and written meeting minutes in which the FDA characterized the statistical significance and magnitude of treatment effect seen in PROSERA as review issues rather than filing issues, and provided feedback on the planned submission’s format and content.

The FDA will next decide whether to accept the NDA for filing after its initial review, which Gossamer said it expects could occur later in 2026. The press release notes that the FDA will determine during its full review whether the application’s efficacy and safety evidence is acceptable.