USFDAApr 23, 2026, 01:15 PM
FDA Issues CRL for Grace Therapeutics' GTx-104 NDA
AI Summary
Grace Therapeutics, Inc. 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, developed for aneurysmal subarachnoid hemorrhage (aSAH) patients. The CRL referenced outstanding items in the Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections, specifically related to leachables data, toxicology risk assessments, and manufacturing deficiencies. The FDA did not request additional clinical data. The company intends to request a Type A meeting with the FDA to clarify the path forward and plans to resubmit the application after resolving the cited issues.
Key Highlights
- FDA issued a Complete Response Letter (CRL) for Grace Therapeutics' GTx-104 New Drug Application (NDA).
- CRL cited outstanding issues in Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections.
- Issues include leachables data, non-clinical product toxicology risk assessments, and manufacturing deficiencies.
- FDA did not request additional clinical data for GTx-104.
- Grace Therapeutics plans to request a Type A meeting and resubmit the NDA.