Grace Therapeutics publishes corporate presentation on GTx-104 IV nimodipine for aSAH

• Grace Therapeutics highlighted FDA complete response letter for GTx-104, an intravenous nimodipine candidate for aneurysmal subarachnoid hemorrhage.
• Company framed letter as driven by CMC package completeness and manufacturing readiness, citing no clinical deficiencies.
• Grace plans to resubmit NDA once cited items are resolved, with work focused on leachable data, nonclinical assessment tied to that dataset, and CDMO remediation.
• Phase 3 STRIVE-ON trial met primary safety endpoint, with clinically significant hypotension in 28% of GTx-104 patients versus 35% on oral nimodipine.
• Presentation also cited 90-day outcomes, including a 29% relative increase in good recovery and 54% of GTx-104 patients achieving at least 95% relative dose intensity versus 8% for oral nimodipine.

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