Gossamer Bio submits NDA to US FDA for seralutinib to treat pulmonary arterial hypertension

Gossamer Bio, Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), announced that it submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in September 2026 for seralutinib for the treatment of PAH. This is the company’s first NDA submission.

The NDA is supported by the phase 3 PROSERA Study as one adequate and well-controlled clinical investigation, together with confirmatory evidence from the 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.

“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.”

“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,” said Caryn Peterson, chief development officer of Gossamer. “It brings us one step closer to delivering seralutinib as a potential new therapy for PAH patients who need better options.”

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, will be determined by the FDA during its review of the complete NDA.

Gossamer Bio is a biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!