Gossamer Bio highlights seralutinib Phase 3 PROSERA data, targets PAH NDA filing

• Gossamer Bio highlighted completed Phase 3 PROSERA study of inhaled seralutinib in pulmonary arterial hypertension.
• Primary endpoint missed its prespecified alpha; placebo-adjusted 6-minute walk distance gain 13.3 meters at week 24, p=0.032.
• Prespecified higher-risk subgroup showed 20.0-meter placebo-adjusted 6-minute walk distance improvement at week 24, p=0.0207.
• Gossamer targets an NDA submission in September 2026, citing a Type B pre-NDA meeting and a one-study-plus-confirmatory-evidence strategy.
• Presentation also outlined a potential FDA decision as early as 3Q27 and cited peak sales potential of more than $2 billion worldwide.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Gossamer Bio Inc. published the original content used to generate this news brief on September 08, 2026, and is solely responsible for the information contained therein.