Grace Therapeutics Inc. Unveils Presentation on GTx-104 for aSAH Treatment, Highlighting Phase 3 Trial Success and Upcoming NDA Review
Reuters
Aug 27
<a href="https://laohu8.com/S/GRCE">Grace Therapeutics</a> Inc. Unveils Presentation on GTx-104 for aSAH Treatment, Highlighting Phase 3 Trial Success and Upcoming NDA Review
Grace Therapeutics Inc. has recently presented an update on their novel intravenous nimodipine, GTx-104, designed for the treatment of aneurysmal Subarachnoid Hemorrhage (aSAH). The presentation highlights that while nimodipine is the standard of care, its only available oral form has significant unmet needs. GTx-104 aims to address these challenges and potentially replace oral nimodipine as the standard of care. The pivotal Phase 3 STRIVE-ON safety trial met its primary endpoint, showing clinical evidence of benefit from GTx-104 compared to oral nimodipine. The company has filed a New Drug Application (NDA) in June 2025, which was accepted for review on August 22, 2025, with a target PDUFA date set for April 23, 2026. Grace Therapeutics underscores the potential of GTx-104 to address severe rare diseases, backed by orphan drug status, market exclusivity, and multi-layered IP protection. You can access the full presentation through the link below.
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