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