Grace Therapeutics Pursues Dual-Source Manufacturing to Address FDA Requirements for GTx-104

Grace Therapeutics has received the official meeting minutes from a recent Type A Meeting with the U.S. Food and Drug Administration (FDA) concerning the Complete Response Letter (CRL) issued for GTx-104 on April 23, 2026. GTx-104 is a novel injectable formulation of nimodipine being developed for intravenous infusion to address significant unmet medical needs in patients with aneurysmal subarachnoid hemorrhage (aSAH).

According to the company, the CRL did not identify any concerns related to the clinical safety or efficacy of GTx-104 and did not require additional clinical data. Instead, the FDA's concerns primarily involve the current good manufacturing practice (cGMP) compliance status of Grace Therapeutics' contract manufacturing organization, along with requests for additional leachables data and excipient toxicology risk assessments. The company plans to address all outstanding requirements in its future resubmission, including completing the necessary non-clinical studies.

“Following receipt of the FDA’s minutes, we have a clear view of what is required and are executing against it, including advancing a second manufacturing source in the United States so that we are not dependent on a single path to resubmission,” said Prashant Kohli, Chief Executive Officer of Grace Therapeutics. “We will report progress as key milestones are achieved. If approved, GTx-104 would represent a meaningful innovation in the care for aSAH, and we are committed to improving outcomes for aSAH patients.” 

To strengthen its manufacturing strategy, Grace Therapeutics is pursuing a dual-source manufacturing approach. Its existing contract manufacturer is working to resolve the cGMP issues identified at its facility and demonstrate readiness for a potential FDA reinspection. At the same time, Grace is transferring manufacturing technology to a second contract manufacturer based in the United States, creating an additional potential pathway for GTx-104 registration.

The company has not yet committed to a single resubmission route and could potentially rely on either manufacturing partner or both. Grace Therapeutics believes the dual-source strategy could provide greater flexibility in meeting regulatory requirements while reducing dependence on a single manufacturing facility as it prepares to resubmit GTx-104 for FDA review.