Catalyst overview
Research summary
This catalyst tracks a Phase 2 data readout for COYA 302 in Amyotrophic lateral sclerosis. The expected timing is based on the latest available company guidance and may change.
ALSTARS Trial. 3/19/24- FDA requested additional non-clinical toxicology/pharmacology data before trial initiation. 9/22/25- Trial initiated. 11/12/25- First patient dosed. Topline data readout before H2 2027. 12/09/25:- Dosing of ALS patients commenced in ALSTARS Ph2 trial. 03/16/26:- ALSTARS Ph2 enrolling across ~25 US/Canada sites; ALS biomarker publication 1H 2026; full enrollment targeted H2 2026. 05/12/26:- FDA granted Fast Track for COYA 302 in ALS; ALSTARS Ph2 ongoing (NCT07161999). Topline ALSTARS Ph2 readout guided for Q1 2027; protocol amended to broaden eligibility and increase recruitment; full enrollment and ALS IIT proteomics data expected H2 2026; ALS conference presentations planned June 2026. 06/08/26:- Blinded extension phase initiated in ALSTARS Ph2; placebo patients re-randomized; up to 48 weeks total data. 06/18/26:- ALSTARS Ph2 trial design overview to be presented at ENCALS 2026 on June 24, 2026.
Verification
Confirm timing and program details against the company announcement or filing.