Gossamer Bio Inc. (NASDAQ: GOSS) has submitted a New Drug Application to the U.S. Food and Drug Administration for seralutinib, marking the company's first NDA filing.
The application, submitted in September 2026, seeks approval for seralutinib as a treatment for pulmonary arterial hypertension (PAH). The company is also advancing the drug for pulmonary hypertension associated with interstitial lung disease.
The NDA is supported by the Phase 3 PROSERA study, which serves as one adequate and well-controlled clinical investigation, along with confirmatory data from the Phase 2 TORREY study and additional supportive analyses.
Prior to the filing, Gossamer held a Pre-NDA Type B meeting with the FDA in June 2026. According to the company, the agency characterized the degree of statistical significance and the magnitude of the treatment effect observed in PROSERA as "review issues rather than filing issues" in its official written meeting minutes.
The FDA will now conduct an initial review to determine whether the NDA will be accepted for formal filing. Gossamer anticipates a decision later in 2026. Individual elements of the application, including efficacy and safety evidence, will be assessed during the full review process.
Faheem Hasnain, chairman, co-founder and CEO of Gossamer, said: "Submitting our first NDA is a significant milestone for Gossamer and, more importantly, for patients living with PAH."
