USFDAJul 28, 2026, 07:21 AM
Grace Therapeutics Advances GTx-104 NDA Resubmission After FDA Meeting
AI Summary
Grace Therapeutics, Inc. announced receipt of U.S. Food and Drug Administration (FDA) meeting minutes for its GTx-104 new drug application, following a Complete Response Letter (CRL). The FDA did not identify any clinical safety or efficacy deficiencies, nor did it request additional clinical data. The CRL issues are related to the current good manufacturing practice (cGMP) compliance status of the company's contract manufacturing organization and additional data requirements. Grace Therapeutics is pursuing a dual-source manufacturing strategy and completing non-clinical studies to address these items for NDA resubmission.
Key Highlights
- Received FDA meeting minutes for GTx-104 NDA following a Complete Response Letter.
- FDA did not identify clinical safety or efficacy deficiencies for GTx-104.
- CRL issues relate to cGMP compliance of contract manufacturer and additional data.
- Company advancing dual-source manufacturing strategy for NDA resubmission.
- GTx-104 is an IV nimodipine for aneurysmal Subarachnoid Hemorrhage (aSAH).
- STRIVE-ON Phase 3 trial met primary endpoint, reducing hypotension by 19%.
- GTx-104 has Orphan Drug Designation, offering 7 years of market exclusivity.
- GTx-104 patent protection extends to 2043.
Price Impact
More from GRCE