Grace Therapeutics posts corporate presentation on GTx-104 IV nimodipine program for aneurysmal subarachnoid hemorrhage

• Grace Therapeutics outlined a targeted FDA NDA resubmission plan for IV nimodipine candidate GTx-104 in aneurysmal subarachnoid hemorrhage.
• Complete response letter centered on CMC and manufacturing; no clinical safety or efficacy deficiencies cited, no additional clinical data requested.
• Strategy includes remediation at the current CDMO requiring FDA reinspection, parallel US second-source transfer, and completion of non-clinical studies.
• Phase 3 STRIVE-ON safety trial met its primary endpoint; clinically significant hypotension occurred in 28% on GTx-104 vs 35% on oral capsules.
• Company highlighted higher dose intensity at 95% or more in 54% of GTx-104 patients vs 8% on oral capsules, with a 29% relative increase in good recovery at 90 days.

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