FDA delays IND review for COYA 302 ALS trial due to workload; decision expected by Aug 29, 2025

Coya Therapeutics, Inc.

Coya submitted IND for Phase 2 ALS study of COYA 302 on June 30, 2025.
FDA informed Coya on July 29, 2025, that it cannot meet initial July 30 review goal due to workload and resource constraints.
FDA expects to provide IND decision no later than August 29, 2025.
Delay affects timeline for starting the planned 24-week placebo-controlled study with 24-week OLE.

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