Core Insights - Grace Therapeutics, Inc. announced that the abstract of its Pivotal Phase 3 STRIVE-ON Safety Trial for GTx-104 has been accepted for late-breaking presentation at the Society of Vascular and Interventional Neurology annual meeting [1][2] Company Overview - Grace Therapeutics is a late-stage biopharma company focused on developing drug candidates for rare and orphan diseases, with a lead clinical asset, GTx-104, targeting aneurysmal subarachnoid hemorrhage (aSAH) [5] - The company utilizes novel drug delivery technologies aimed at improving the performance of existing drugs, achieving faster onset of action, enhanced efficacy, and reduced side effects [5] Product Details - GTx-104 is a clinical-stage injectable formulation of nimodipine designed for IV infusion in aSAH patients, addressing significant unmet medical needs [4] - The unique nanoparticle technology of GTx-104 allows for an aqueous formulation of insoluble nimodipine, facilitating standard peripheral IV infusion [4] - GTx-104 has been administered to over 200 patients and healthy volunteers, demonstrating good tolerance and significantly lower pharmacokinetic variability compared to oral nimodipine [4] Clinical Trial Information - The STRIVE-ON trial (NCT05995405) focuses on the safety and tolerability of GTx-104 compared to oral nimodipine in patients with aSAH [3] - The oral presentation of the trial results is scheduled for November 21, 2025, at the SVIN annual meeting [2][3] Market Context - Aneurysmal subarachnoid hemorrhage (aSAH) accounts for approximately 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. annually [3]

Company Overview - Grace Therapeutics, Inc. is a late-stage biopharma company focused on developing GTx-104, a novel injectable formulation of nimodipine for IV infusion targeting aneurysmal subarachnoid hemorrhage (aSAH) [1][7] - The company has received Orphan Drug Designation from the FDA for its lead clinical assets, providing seven years of marketing exclusivity post-launch in the U.S. and has over 40 granted and pending patents [7] Product Details - GTx-104 is designed to address significant unmet medical needs in aSAH patients, facilitating a convenient IV delivery method that may eliminate the need for nasogastric tube administration [5][6] - The product has been administered to over 150 healthy volunteers, showing good tolerance and significantly lower pharmacokinetic variability compared to oral nimodipine [6] Market Context - Aneurysmal subarachnoid hemorrhage accounts for approximately 5% of all strokes, with an estimated 42,500 patients treated in U.S. hospitals annually [4] - The BIO International Convention, where the CEO will participate, is the largest biotechnology event globally, attracting over 20,000 leaders from various sectors including biopharma and investment [2]