Gossamer Bio Q1 Earnings Call Highlights

Gossamer Bio (NASDAQ:GOSS) said it is moving up with plans to question U.S. support for seralutinib successful pulmonary arterial hypertension, outlining a September 2026 people for a New Drug Application submission portion besides detailing caller imaging information and steps to code its equilibrium expanse during its first-quarter 2026 net call.

The company’s executives said the regulatory strategy is based connected the totality of grounds from the Phase 3 PROSERA survey and the Phase 2 TORREY study. Chief Executive Officer Faheem Hasnain said Gossamer’s “conviction successful seralutinib has accrued since the top-line readout, not decreased,” citing PROSERA, TORREY, caller CT imaging results and ongoing engagement with the Food and Drug Administration.

FDA gathering acceptable for June up of planned NDA filing

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Caryn Peterson said Gossamer is pursuing an NDA nether a model of “one capable and well-controlled objective probe positive confirmatory evidence.” She said the institution believes PROSERA tin service arsenic the capable and well-controlled study, portion TORREY provides confirmatory evidence.

Peterson said Gossamer had initially considered a Type C gathering with the FDA but is present moving guardant with a Type B pre-NDA meeting, which she described arsenic a ceremonial pre-submission interaction. The institution submitted the gathering petition successful April 2026, and the FDA has granted an in-person gathering successful mid-June.

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“Based connected that timing, our NDA submission people remains successful September this year, taxable to the result of the pre-NDA meeting,” Peterson said. If the process proceeds arsenic expected, she said a imaginable support could travel successful the 3rd 4th of 2027.