Grace Therapeutics Receives FDA CRL for GTx-104; Plans Resubmission
Grace Therapeutics, Inc. announced it received a Complete Response Letter (CRL) from the FDA in April 2026 for its New Drug Application (NDA) for GTx-104, an intravenous nimodipine for aneurysmal subarachnoid hemorrhage (aSAH). The CRL cited chemistry, manufacturing, and controls (CMC) and non-clinical information, with no clinical deficiencies identified. The company plans to resubmit the NDA after resolving these items and has scheduled a Type A meeting with the FDA. The updated corporate presentation also highlighted positive Phase 3 STRIVE-ON trial data for GTx-104, showing a 19% reduction in hypotension and a 29% relative increase in good recovery at 90 days compared to oral capsules. As of March 31, 2026, the company reported $17.0 million in cash and cash equivalents.
Key Highlights
- FDA issued a Complete Response Letter (CRL) for GTx-104 NDA in April 2026, citing CMC and manufacturing issues.
- No clinical deficiencies were identified in the CRL for GTx-104.
- Phase 3 STRIVE-ON trial for GTx-104 showed a 19% reduction in clinically significant hypotension.
- GTx-104 patients had a 29% relative increase in good recovery at 90 days compared to oral capsules.
- GTx-104 demonstrated 1.5 fewer ICU days and 5 fewer ventilator days than oral capsules.
- Cash and cash equivalents stood at $17.0 million as of March 31, 2026.
- Potential gross proceeds of $15.0 million from the exercise of outstanding warrants.
Price Impact
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