GTX-104 - (STRIVE-ON)

July 28, 2026: Grace Therapeutics, Inc. (NASDAQ: GRCE) said it received FDA Type A meeting minutes regarding the Complete Response Letter (CRL) issued April 23, 2026 for its NDA for GTx-104 (IV nimodipine formulation) for aneurysmal subarachnoid hemorrhage (aSAH). The company stated the CRL did not cite any clinical safety or efficacy deficiencies and did not request additional clinical data; issues were tied to the cGMP compliance status of its contract manufacturing organization (a facility-level matter), plus requests for additional leachables time points and excipient toxicology risk assessments (including required non-clinical studies).

To support an NDA resubmission, Grace is pursuing a dual-source manufacturing strategy: remediation and inspection readiness at the current contract manufacturer (ultimately requiring FDA reinspection) and, in parallel, tech transfer to a second, U.S.-based contract manufacturer. A resubmission may be supported by either or both sites.

The press release also recapped STRIVE-ON (NCT05995405), where GTx-104 met its primary endpoint vs oral nimodipine with fewer clinically significant hypotension episodes (28% vs 35%), higher relative dose intensity ≥95% (54% vs 8%), and comparable adverse events; deaths were 8 vs 4 (one oral patient unknown), with none deemed treatment-related.