Grace Therapeutics Inc. has released a corporate presentation detailing the development of GTx-104, a novel intravenous formulation of nimodipine for the treatment of aneurysmal subarachnoid hemorrhage (aSAH). The company reported that the pivotal Phase 3 STRIVE-ON safety trial met its primary endpoint, demonstrating a lower incidence of clinically significant hypotension compared to oral nimodipine. GTx-104 is designed to address delivery challenges associated with the oral standard of care and has been granted Orphan Drug Status, providing seven years of market exclusivity and multi-layered intellectual property protection. The New Drug Application for GTx-104 was filed in June 2025 and accepted for review by the FDA, with a target Prescription Drug User Fee Act (PDUFA) date of April 23, 2026. Additional data from the trial indicate favorable patient-reported health outcomes for GTx-104 versus oral nimodipine. You can access the full presentation through the link below.

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