Announcement • Jun 19
Grace Therapeutics Provides Update On GTx-104 NDA Resubmission And Reports Phase 3 STRIVE-ON Safety Trial Data
Grace Therapeutics received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for GTx-104 for the treatment of patients with aneurysmal Subarachnoid Hemorrhage (aSAH) on April 23, 2026. In the CRL, the FDA referenced certain items in the Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections of the application, which Grace believes it can address in a resubmission of its NDA. The cited items are related to additional leachable data time points for commercial product, non-clinical product toxicology risk assessments, and current Good Manufacturing Practices (cGMP) deficiencies with the contract manufacturing organization. No clinical deficiencies were identified. A Type A meeting with the FDA has been scheduled to potentially clarify the path forward and determine the appropriate next steps. The Company expects to provide a regulatory update after the receipt of official meeting minutes. Phase 3 STRIVE-ON trial results were presented at multiple major medical conferences over the last twelve months: 2026 American Academy of Neurology (April 18-22, 2026, Chicago, IL), Society of Critical Care Medicine’s Critical Care Congress (March 22-24, 2026, Chicago, IL), American Association of Neuroscience Nurses (March 21-24, 2026, Dallas, TX), Society of Vascular and Interventional Neurology (November 19-22, 2025, Orlando, FL), and 2025 Neurocritical Care Society (September 18-21, 2025, Montreal, Quebec). The U.S. Patent and Trademark Office issued a U.S. Patent No. 12,414,943, titled “Nimodipine Parenteral Administration”. The method of use patent, published on September 16, 2025, covers the dosing regimen for IV administration of nimodipine used in the Phase 3 STRIVE-ON safety trial for GTx-104. Grace Therapeutics has established a multi-layered intellectual property estate for GTx-104, including five patents on the composition of the Company’s formulation of nimodipine, which provide patent protection to 2037. The new patent on the IV dosing regimen for GTx-104 strengthens the Company’s intellectual property position and extends protection to 2043. The STRIVE-ON trial (NCT05995405) was a prospective, randomized open-label trial of GTx-104 compared with nimodipine oral capsules (oral nimodipine) in patients hospitalized with aSAH. 50 patients were administered GTx-104 and 52 patients received oral nimodipine. The primary endpoint was the number of patients with at least one episode of clinically significant hypotension reasonably considered to be caused by the drug, and additional secondary endpoints included safety, clinical, and pharmacoeconomic outcomes. The trial met its primary endpoint, with patients receiving GTx-104 observed to have a 19% reduction in at least one incidence of clinically significant hypotension compared to oral nimodipine (28% versus 35%). Other measures also favored GTx-104 or were comparable between the GTx-104 arm and the oral nimodipine arm, including: 54% patients on GTx-104 had relative dose intensity (RDI) of 95% or higher compared to only 8% on oral nimodipine, and 29% more patients on GTx-104 than on oral nimodipine had favorable functional outcomes at 90 days. In addition, there were fewer intensive care unit (ICU) readmissions, ICU days, and ventilator days for patients receiving GTx-104 versus oral nimodipine. Adverse events were comparable between the two arms and no new safety issues were identified with patients receiving GTx-104. All deaths in both arms of the trial were due to severity of the patient’s underlying disease. There were eight deaths in the GTx-104 arm compared to four deaths in the oral nimodipine arm. The survival status of one patient in the oral nimodipine arm was unknown. No deaths were determined to be related to GTx-104 or oral nimodipine. GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for IV infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to nimodipine oral capsules.
