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.
