Grace Therapeutics announces FDA alignment supporting GTx-104 NDA submission; submission expected Q2 2025

Grace Therapeutics, Inc.

Primary endpoint met: 19% reduction in clinically significant hypotension (28% GTx-104 vs 35% oral nimodipine).
54% of GTx-104 patients had relative dose intensity ≥95% vs 8% on oral nimodipine.
29% more patients had favorable functional outcomes at 90 days with GTx-104.
8 deaths on GTx-104 vs 4 on oral; none determined drug-related.
NDA submission for GTx-104 anticipated in Q2 2025.

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