Grace Therapeutics submits NDA for GTx-104 in aSAH; Phase 3 data positive

Grace Therapeutics, Inc.

NDA for GTx-104 (injectable nimodipine) submitted to FDA for aneurysmal subarachnoid hemorrhage.
Phase 3 STRIVE-ON trial met primary endpoint: 19% reduction in clinically significant hypotension vs oral nimodipine.
54% of GTx-104 patients had relative dose intensity ≥95% vs 8% on oral; 29% more favorable functional outcomes at 90 days.
Submission may trigger exercise of warrants issued in Sept 2023, yielding up to $7.6M gross proceeds.
GTx-104 has FDA Orphan Drug Designation, providing 7 years U.S. exclusivity if approved.

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