Grace Therapeutics, Inc.
Grace Therapeutics, Inc. is a late-stage biopharmaceutical company dedicated to developing drug candidates that target rare and orphan diseases. The company aims to disrupt the standard of care in various neurological diseases and improve clinical outcomes through its novel drug delivery technologies. Its principal executive offices are located in Princeton, New Jersey, United States.
Grace Therapeutics specializes in applying proprietary formulations to approved pharmaceutical compounds to enhance efficacy, accelerate onset of action, reduce side effects, and provide more convenient drug delivery. The company's pipeline focuses on underserved orphan diseases, including aneurysmal subarachnoid hemorrhage (aSAH), Ataxia-telangiectasia (A-T), and Postherpetic Neuralgia (PHN). Its lead clinical asset, GTx-104, is a novel injectable formulation of nimodipine designed for intravenous infusion in aSAH patients. Other key pipeline candidates include GTx-102, an oral mucosal spray for A-T, and GTx-101, a topical treatment for PHN.
In April 2026, Grace Therapeutics announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for GTx-104. The CRL cited issues related to chemistry, manufacturing, and controls (CMC) and non-clinical information, but did not request additional clinical data. The company plans to resubmit the application following the resolution of these items and intends to engage with the FDA in a Type A meeting. Prashant Kohli serves as the Chief Executive Officer, leading the company's efforts in advancing its pipeline. Grace Therapeutics is publicly traded on the NASDAQ under the ticker symbol GRCE.
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