Grace Therapeutics issued Complete Response Letter from FDA

Grace Therapeutics (GRCE) announced that the U.S. Food and Drug Administration has issued a Complete Response Letter for the company’s New Drug Application for GTx-104 for the treatment of patients with aSAH. “In its CRL, the FDA referenced certain items in the Chemistry, Manufacturing, and Controls 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 leachables data for product packaging, non-clinical product toxicology risk assessments, and product manufacturing deficiencies at our contract manufacturing organization. The Company intends to request a Type A meeting with the FDA to clarify the path forward and determine the appropriate next steps,” Grace stated. “Potential FDA approval of our NDA for GTx-104 for the treatment of aSAH would represent the first meaningful innovation in the standard of care for these patients in more than 40 years. We are confident in the robust data package supporting our NDA submission, and that the CMC issues identified by the FDA can be successfully addressed in our resubmission,” said Prashant Kohli, Chief Executive Officer of Grace Therapeutics.