FDA accepts Grace Therapeutics' NDA for GTx-104; PDUFA date set for April 23, 2026

Grace Therapeutics, Inc.

FDA accepted NDA for GTx-104 (injectable nimodipine) for aSAH treatment; PDUFA target April 23, 2026.
Acceptance triggers up to $7.6M in warrants exercisable at $3.003/share, expiring 60 days post-acceptance or Sept 25, 2028.
Phase 3 STRIVE-ON trial met primary endpoint: 19% reduction in clinically significant hypotension vs oral nimodipine (28% vs 35%).
GTx-104 showed 54% of patients had ≥95% relative dose intensity vs 8% for oral; 29% more favorable functional outcomes at 90 days.
Orphan Drug Designation provides 7-year US marketing exclusivity if approved.

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