Grace Therapeutics Inc. has provided an overview of its lead product candidate, GTx-104, a novel intravenous formulation of nimodipine designed for the treatment of aneurysmal subarachnoid hemorrhage (aSAH). The company highlights unmet needs with the current standard of care, oral nimodipine, and positions GTx-104 as a potential alternative that may address oral delivery challenges. The pivotal Phase 3 STRIVE-ON safety trial met its primary endpoint, demonstrating clinical evidence of benefit compared to oral nimodipine. GTx-104 has received Orphan Drug Status, granting seven years of market exclusivity, and is supported by additional intellectual property protections. The New Drug Application (NDA) for GTx-104 was filed in June 2025 and accepted for review in August 2025, with a target Prescription Drug User Fee Act (PDUFA) date of April 23, 2026. You can access the full presentation through the link below.