Grace Therapeutics posts investor deck on IV nimodipine candidate GTx-104 for aneurysmal subarachnoid hemorrhage

• Grace Therapeutics outlined a path to resubmit the GTx-104 IV nimodipine NDA following an FDA Type A meeting.
• Complete response letter centered on CMC and manufacturing; no clinical safety or efficacy deficiencies cited, no additional clinical data requested.
• Strategy targets dual-source manufacturing, with remediation at the current CDMO requiring FDA reinspection, alongside US second-source transfer.
• Phase 3 STRIVE-ON safety trial met its primary endpoint, with clinically significant hypotension in 28% on GTx-104 vs 35% oral capsules.
• Data showed 54% of GTx-104 patients received at least 95% of prescribed dose vs 8% for oral capsules; 90-day good recovery rose 29%.

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