Gossamer Bio targets a New Drug Application filing for seralutinib in September 2026, with potential approval by Q3 2027.
Gossamer Bio Inc. (GOSS) announced plans to submit a New Drug Application (NDA) for seralutinib in September 2026. The company anticipates potential regulatory approval by Q3 2027, pending clinical trial outcomes and regulatory reviews.
The timeline follows Gossamer Bio’s Q1 2026 earnings call, where management outlined the drug’s development roadmap. Seralutinib is being evaluated for specific therapeutic indications, though no prior regulatory filings for this compound have been reported.
No immediate market reaction was disclosed in the source material.