Gossamer Bio Inc.
(NASDAQ:GOSS) stock is trading higher on Monday as the company is preparing to submit a New Drug Application (NDA) for its lead candidate, seralutinib, in September 2026 following a pre-NDA Type B meeting with the U.S.
Food and Drug Administration (FDA).
The clinical-stage biopharmaceutical company announced the timeline alongside major corporate updates, including regaining full global commercial rights to the candidate and completing significant balance sheet restructuring.
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