other material
confidence high
sentiment positive
materiality 0.65
Acasti Pharma completes enrollment in pivotal Phase 3 STRIVE-ON trial of GTX-104 for aSAH
Grace Therapeutics, Inc.
- Patient enrollment completed for GTX-104 (injectable nimodipine) vs oral nimodipine in 100 patients across ~25 U.S. hospitals.
- Data readout from STRIVE-ON safety trial expected early calendar 2025; primary endpoint is comparative adverse events including hypotension.
- NDA submission to FDA on track for first half of 2025, consistent with timeline.
- CEO Prashant Kohli says milestone achieved ahead of original expectations; believes GTX-104 may transform aSAH standard of care.