regulatory
confidence high
sentiment neutral
materiality 0.60
Coya re-submits IND for COYA 302 ALS Phase 2 study after FDA request
Coya Therapeutics, Inc.
- Re-submitted IND to FDA on June 30, 2025, including requested non-clinical data.
- Previous FDA request on July 14, 2024, for additional non-clinical data.
- Plans to initiate Phase 2 study upon IND acceptance.
- Study: randomized, double-blind, placebo-controlled, 24-week with 24-week OLE, evaluating COYA 302 for ALS.
item 8.01