Grace Therapeutics Receives FDA CRL for GTx-104 NDA Citing CMC and cGMP Deficiencies at CMO

A Complete Response Letter issued by the FDA on April 23, 2026, has put Grace Therapeutics' NDA for GTx-104, an injectable nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH), into resubmission planning, with deficiencies concentrated in CMC and cGMP compliance at the company's contract manufacturing organization. No clinical deficiencies were cited, which narrows the remediation scope but does not simplify it.

The CRL identified three discrete gaps: additional leachables data time points for the commercial product, non-clinical product toxicology risk assessments, and cGMP deficiencies at the CMO. For QA directors and regulatory leads preparing their own NDA packages, the leachables finding is a pointed reminder that extractables and leachables data packages must reflect commercial-scale, time-matched sampling, not just development-phase profiles. The CMO compliance gap reinforces the due-diligence burden that 21 CFR Part 211 places on sponsors for contractor oversight, regardless of where manufacturing physically occurs.

Grace has scheduled a Type A meeting with the FDA to clarify the resubmission pathway and determine appropriate next steps. The company has indicated it will issue a regulatory update following receipt of official meeting minutes, a standard sequencing that gives QA and regulatory teams a defined checkpoint to watch. The Type A designation signals that FDA has agreed the issues are sufficiently defined to warrant a structured, time-bound meeting rather than an open-ended information request cycle.

On the intellectual property side, the U.S. Patent and Trademark Office issued U.S. Patent No. 12,414,943 covering the IV dosing regimen used in the Phase 3 STRIVE-ON safety trial, extending protection to 2043. Combined with five existing composition-of-matter patents running to 2037 and Orphan Drug Designation providing seven years of U.S. marketing exclusivity upon approval, the IP estate remains intact through the resubmission period. Phase 3 STRIVE-ON data were presented at five major medical conferences across fiscal 2026, including the American Academy of Neurology and the Neurocritical Care Society.

The outcome of the scheduled Type A meeting and the subsequent resubmission timeline will be the measurable indicators of whether Grace's CMC remediation strategy, particularly the leachables data package and CMO cGMP corrective actions, satisfies FDA's outstanding requirements.

Source: Grace Therapeutics, Inc. via GlobeNewswire, June 18, 2026.