Acasti achieves >50% enrollment in pivotal Phase 3 STRIVE-ON safety trial for GTX-104

Grace Therapeutics, Inc.

Phase 3 STRIVE-ON trial of GTX-104 (IV nimodipine) for aneurysmal subarachnoid hemorrhage (aSAH) surpassed 50% patient enrollment.
Trial design: 100 patients, open-label, randomized 1:1 vs oral nimodipine; primary endpoint is comparative safety (hypotension).
Enrollment began Oct 2023; completion anticipated late 2024–early 2025; NDA submission on track for 1H 2025.
GTX-104 is designed for IV infusion in ICU, avoiding nasogastric tube in unconscious/dysphagic aSAH patients.
US addressable market for GTX-104 estimated at ~$300M per market research.

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