Grace Therapeutics Inc. has provided an update on GTx-104, its novel intravenous formulation of nimodipine, developed for the treatment of aneurysmal subarachnoid hemorrhage (aSAH). GTx-104 is designed to address challenges associated with the oral administration of nimodipine, the current standard of care, by offering an intravenous option that may improve drug delivery and patient outcomes. The pivotal Phase 3 STRIVE-ON safety trial met its primary endpoint and demonstrated clinical evidence of benefit compared to the oral formulation. GTx-104 has been granted Orphan Drug Status, providing seven years of market exclusivity and additional intellectual property protection. The company filed a New Drug Application (NDA) for GTx-104 in June 2025, which was accepted for review in August 2025. The target Prescription Drug User Fee Act (PDUFA) date is set for April 23, 2026. You can access the full presentation through the link below.