Gossamer Bio Shares Surge 25% on FDA Update and Seralutinib Rights Return
Gossamer Bio Inc. (NASDAQ:GOSS) shares jumped 25% on Monday following a positive regulatory update from the FDA regarding its lead drug candidate seralutinib for pulmonary arterial hypertension (PAH). The company completed a Pre-NDA Type B meeting with the FDA, which indicated that statistical significance questions from the Phase 3 PROSERA trial would be review issues, not filing obstacles. Gossamer plans to submit its New Drug Application (NDA) in September 2026, with a potential FDA decision in Q3 2027. Additionally, Gossamer reacquired worldwide rights to seralutinib from Chiesi, terminating a previous 50/50 U.S. profit-sharing agreement. Chiesi will make a $5 million one-time payment and remain eligible for capped royalties and milestone payments. Earlier in July, shareholders approved debt restructuring that reduced outstanding principal by $115.9 million. As of June 30, the company held approximately $57 million in cash and securities.
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