Gossamer Bio Submits First NDA to FDA for Seralutinib in Pulmonary Arterial Hypertension
核心洞察
Gossamer Bio submitted its first New Drug Application to the FDA in September 2026 for seralutinib as a treatment for pulmonary arterial hypertension (搜索).
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.
FDA meeting minutes from a June 2026 Pre-NDA Type B meeting characterized PROSERA's statistical significance and treatment effect magnitude as review issues, not 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 company's first NDA submission. The filing was made in September 2026, and the company disclosed it on September 23, 2026.
Seralutinib is the company's lead asset, and Gossamer is developing it for both PAH and pulmonary hypertension associated with interstitial lung disease (搜索) (PH-ILD).
Evidence Base for the Filing
The NDA is supported by the Phase 3 PROSERA study, which serves as one adequate and well-controlled clinical investigation, together with confirmatory evidence from the Phase 2 TORREY study and additional supportive analyses.
The submission follows a Pre-NDA Type B meeting with the FDA held in June 2026 and the agency's official written meeting minutes. According to Gossamer, 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.
Regulatory Next Steps
The FDA will determine whether to accept the NDA for filing following its initial review of the application. Gossamer anticipates that decision could come later this year. The company noted that the acceptability of the individual elements of the application, including the efficacy and safety evidence, will be determined by the FDA during its review of the complete NDA.
Company Commentary
"Submitting our first NDA is a significant milestone for Gossamer and, more importantly, for patients living with PAH," said Faheem Hasnain, Chairman, Co-Founder and Chief Executive Officer of Gossamer. "We are grateful to the patients, families, investigators and site staff who made PROSERA and TORREY possible, and to our employees for the work it took to reach this point."
Caryn Peterson, Chief Development Officer of Gossamer, described the submission as the product of work across multiple functions. "This submission is the result of years of scientific rigor and the collective effort of colleagues across clinical development, biostatistics, regulatory affairs, manufacturing, quality and many other functions," Peterson said. "It brings us one step closer to delivering seralutinib as a potential new therapy for PAH patients who need better options."
Development Program
Gossamer Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for PAH and PH-ILD. The company states that its goal is to be an industry leader in pulmonary hypertension and to enhance the lives of patients living with the condition. Gossamer cautions that its forward-looking statements regarding FDA review, potential acceptance for filing and approval of the NDA, and the interpretation of data from PROSERA and TORREY are subject to risks, including the possibility that the FDA determines the NDA does not qualify for filing or that the overall benefit-risk assessment of seralutinib is not favorable.