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Gossamer Bio提交Seralutinib治疗肺动脉高压的NDA

2026-09-24 06:16

Gossamer Bio(GOSS) 0
硕迪生物(GPCR) 0

Gossamer Bio (GOSS) has submitted an NDA to the US FDA seeking approval of seralutinib for pulmonary arterial hypertension (PAH).
The application is supported by data from the phase 3 PROSERA study, evidence from the phase 2 TORREY study, and supportive analyses.
Results from the phase 3 trial, released in February, found that seralutinib did not meet its primary endpoint, placebo-adjusted improvement in Six-Minute Walk Distance (6MWD), as the results missed statistical significance.
The NDA submission is the first for Gossamer.

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