Grace Therapeutics posts investor deck on IV nimodipine candidate GTx-104 for aneurysmal subarachnoid hemorrhage
GRCE•Phase 3 STRIVE-ON data highlighted
Phase 3 STRIVE-ON safety trial met its primary endpoint, with clinically significant hypotension in 28% on GTx-104 versus 35% on oral capsules.
Data showed 54% of GTx-104 patients received at least 95% of the prescribed dose versus 8% for oral capsules; 90-day good recovery rose 29%.
Resubmission path outlined after FDA Type A meeting
Grace Therapeutics outlined a path to resubmit the GTx-104 IV nimodipine NDA following an FDA Type A meeting.
The complete response letter centered on CMC and manufacturing issues; no clinical safety or efficacy deficiencies were cited, and no additional clinical data were requested.
The company said its strategy targets dual-source manufacturing, with remediation at the current CDMO requiring FDA reinspection, alongside a U.S. second-source transfer.
