Key Points – Gossamer Bio is still targeting a September 2026 NDA submission for seralutinib in pulmonary arterial hypertension, with a June FDA pre-NDA meeting set to help shape the filing.
Management said approval could potentially follow in the third quarter of 2027 if the process stays on track. – The company highlighted efficacy and imaging data from PROSERA and the CT-FRI sub-study, saying seralutinib showed a 13.3-meter placebo-adjusted improvement in six-minute walk distance and favorable signals across arterial, venous and fibrosis-like imaging measures
Gossamer believes the totality of evidence could support a differentiated label and commercial profile. – Gossamer also addressed its balance sheet, saying it had $99 million in cash at quarter-end and expects runway into Q1 2027. It announced a convertible note exchange that could cut debt from $200 million to $72 million and push maturity out to 2030. Gossamer Bio (NASDAQ:GOSS) said it is moving ahead with plans to seek U.S. approval for seralutinib in pulmonary arterial hypertension, outlining a September 2026 target for a New Drug Application submission while also detailing new imaging data and steps to address its balance sheet during its first-quarter 2026 earnings call.
The company’s executives said the regulatory strategy is based on the totality of evidence from the Phase 3 PROSERA study and the Phase 2 TORREY study. Chief Executive Officer Faheem Hasnain said Gossamer’s “conviction in seralutinib has increased since the top-line readout, not decreased,” citing PROSERA, TORREY, new CT imaging results and ongoing engagement with the Food and Drug Administration. FDA meeting set for June ahead of planned NDA filing Caryn Peterson said Gossamer is pursuing an NDA under a framework of “one adequate and well-controlled clinical investigation plus confirmatory evidence.” She said the company believes PROSERA can serve as the adequate and well-controlled study, while TORREY provides confirmatory…