Catalyst overview
Research summary
This catalyst tracks a Phase 2 update for ML-004 (Undisclosed Mechanism) in Autism Spectrum Disorder. The expected timing is based on the latest available company guidance and may change.
05/14/26:- IRIS randomized 161 participants. Topline Phase 2 results remain expected by Mid-August 2026. 06/22/26:- IRIS Ph2 topline missed primary endpoint; prespecified adolescent irritability subgroup improved. Company plans End-of-Phase 2 FDA meeting. 08/13/26:- IRIS Phase 2 safety was favorable. The company will evaluate strategic options after an End-of-Phase 2 Food and Drug Administration discussion.
Verification
Confirm timing and program details against the company announcement or filing.