USFDAJul 28, 2026, 07:02 AM
Grace Therapeutics addresses FDA CRL for GTx-104; dual manufacturing
AI Summary
Grace Therapeutics received meeting minutes from the FDA regarding the Complete Response Letter (CRL) for its drug candidate, GTx-104. The FDA did not identify any clinical safety or efficacy deficiencies and did not request additional clinical data. The CRL issues primarily concern the current good manufacturing practice (cGMP) compliance status of the company's contract manufacturing organization, along with requests for additional leachables data and excipient toxicology risk assessments. Grace Therapeutics is advancing a dual-source manufacturing strategy, including adding a U.S.-based site, to address these items for NDA resubmission.
Key Highlights
- FDA issued a Complete Response Letter (CRL) on April 23, 2026, for GTx-104.
- FDA did not identify clinical safety or efficacy deficiencies for GTx-104.
- CRL issues relate to cGMP compliance of the contract manufacturing organization.
- Additional leachables data and excipient toxicology risk assessments were requested.
- Company is pursuing a dual-source manufacturing strategy for resubmission.
- GTx-104 met primary endpoint in STRIVE-ON trial with 19% reduction in hypotension.
- 54% of GTx-104 patients had 95%+ relative dose intensity vs. 8% for oral nimodipine.
- 29% more GTx-104 patients had favorable functional outcomes at 90 days.
Price Impact
More from GRCE