Grace Therapeutics Updates on GTx-104 FDA Complete Response Letter and Path to Resubmission

Grace Therapeutics, Inc. (Nasdaq: GRCE) provided a corporate presentation updating the status of its lead candidate, GTx-104, a novel intravenous nimodipine for aneurysmal subarachnoid hemorrhage (aSAH). In April 2026, the company received a Complete Response Letter (CRL) from the FDA. The CRL cited deficiencies related to Chemistry, Manufacturing, and Controls (CMC) data package completeness, specifically regarding leachable data from the commercial CDMO and manufacturing readiness/compliance observations at the facility. No clinical deficiencies or new safety signals were identified. The company has scheduled a Type A meeting with the FDA to clarify the path toward resubmission. Grace believes it can address the CRL items by generating baseline data from the commercial site and completing longitudinal datasets. Additionally, the company highlighted positive Phase 3 STRIVE-ON safety trial results, which met the primary endpoint with a 19% reduction in clinically significant hypotension compared to oral nimodipine. As of March 31, 2026, Grace reported $17.0 million in cash and equivalents, with potential additional proceeds of $15.0 million from warrant exercises.