Grace Therapeutics posts corporate presentation on GTx-104 IV nimodipine program for aneurysmal subarachnoid hemorrhage
GRCE•Phase 3 safety trial results
- The Phase 3 STRIVE-ON safety trial met its primary endpoint; clinically significant hypotension occurred in 28% on GTx-104 vs 35% on oral capsules.
- The 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.
Corporate presentation outlines FDA resubmission plan
- Grace Therapeutics outlined a targeted FDA NDA resubmission plan for IV nimodipine candidate GTx-104 in aneurysmal subarachnoid hemorrhage.
- The complete response letter centered on CMC and manufacturing; no clinical safety or efficacy deficiencies were cited, and no additional clinical data were requested.
- The strategy includes remediation at the current CDMO requiring FDA reinspection, parallel US second-source transfer, and completion of non-clinical studies.
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