Grace Therapeutics, Inc. Common Stock
GRCEGrace Therapeutics, Inc. (GRCE) is a biopharmaceutical company focused on developing innovative therapies for the treatment of neurological and neurological-related disorders. The company engages in the identification, development, and commercialization of novel medications designed to address unmet medical needs in various medical conditions.
Company News
Law firm Holzer & Holzer is investigating whether Grace Therapeutics complied with federal securities laws following the FDA's issuance of a Complete Response Letter for its GTx-104 drug application on April 23, 2026. The CRL cited issues with packaging leachables data, non-clinical toxicology assessments, and manufacturing deficiencies, causing ...
Grace Therapeutics announced that its STRIVE-ON Phase 3 trial results for GTx-104, an injectable nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH), have been accepted for presentation at the 2026 American Academy of Neurology annual meeting. The trial met its primary endpoint, showing GTx-104 reduced clinically significant hypo...
Grace Therapeutics announced that CEO Prashant Kohli will present at TD Cowen's 46th Annual Health Care Conference on March 4, 2026. The company also revealed that the FDA established April 23, 2026 as the PDUFA target date for review of GTx-104, an IV infusion formulation of nimodipine being developed for aneurysmal subarachnoid hemorrhage (aSAH...
Grace Therapeutics announced that its Phase 3 STRIVE-ON trial for GTx-104, a novel injectable formulation of nimodipine, met its primary endpoint and showed evidence of clinical benefit over oral nimodipine in aSAH patients. The company plans to submit a New Drug Application (NDA) for GTx-104 in the first half of 2025.
