GOSS biotech catalysts & pipeline

GOSSAMER BIO INC · Data as of 2026-10-25

Upcoming catalysts

seralutinib — Filing acceptance

2026

The FDA will determine whether to accept the NDA for filing following its initial review of the application, which the Company anticipates could occur later this year. The acceptability of the individual elements of the application, including the efficacy and safety evidence, would be determined by the FDA during its substantive review of the complete NDA.

Source filing

seralutinib — Regulatory decision

Q3 2027

• On that basis, the Company intends to submit an NDA supported by one adequate and well-controlled study (Phase 3 PROSERA) plus confirmatory evidence (Phase 2 TORREY and supportive analyses) in September 2026. If accepted for filing, seralutinib could be eligible for an FDA approval decision in the third quarter of 2027.

Source filing

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