FDA Did Not Identify Any Clinical Safety or Efficacy Deficiencies and Did Not Request Additional Clinical Data

Company Advancing a Dual-Source Manufacturing Strategy, Adding a U.S.-Based Site, Toward NDA Resubmission

PRINCETON, N.J., July 28, 2026 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (NASDAQ:GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aSAH patients, today announced receipt of the U.S. Food and Drug Administration (FDA) meeting minutes from a Type A Meeting held with the FDA to discuss the Complete Response Letter (CRL) issued on April 23, 2026. The minutes constitute the official record of the Type A meeting.

As previously disclosed, the CRL did not identify any clinical safety or efficacy deficiencies and did not request additional clinical data. The items cited by the FDA relate to the current good manufacturing practice (cGMP) compliance status of the Company's contract manufacturing organization — a facility-level matter, and not a GTx-104 product-specific quality finding — together with additional leachables data time points and excipient toxicology risk assessments. The Company intends to address each of the CRL items in its planned resubmission, including completing the required non-clinical studies.

As part of that plan, the Company is pursuing a dual-source manufacturing strategy. Its current contract manufacturer is responsible for remediating the cGMP matters identified at its facility and demonstrating inspection readiness, which would ultimately need to be verified through an FDA reinspection. In parallel, the Company is advancing technology transfer to a second-source contract manufacturer located in the United States. This approach gives GTx-104 more than one route to a compliant registration site and reduces reliance on any single manufacturing source. The Company has not designated a single path to resubmission; a resubmission may be supported by either contract manufacturer, or both.