Grace Therapeutics, Inc. announced the receipt of FDA meeting minutes from a Type A meeting held on July 28, 2026, regarding the Complete Response Letter issued on April 23, 2026, for its New Drug Application for GTx-104. The FDA did not identify clinical safety or efficacy deficiencies nor request additional clinical data. The CRL items relate to cGMP compliance at the current contract manufacturer's facility, additional leachables data, and excipient toxicology risk assessments. The company plans to address these issues through a dual-source manufacturing strategy, including remediation at the current site and technology transfer to a second-source contract manufacturer in the United States. Grace Therapeutics operates in the biopharmaceutical industry, developing novel drug delivery technologies for rare diseases.
