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Grace Therapeutics Announces Receipt of Type A Meeting Minutes from U.S. Food and Drug Administration

GRCE
  • Grace Therapeutics received FDA meeting minutes from a Type A meeting held regarding the Complete Response Letter (CRL) issued on April 23, 2026.
  • The FDA did not identify clinical safety or efficacy deficiencies nor request additional clinical data for GTx-104.
  • FDA CRL items relate to cGMP compliance at a contract manufacturing organization facility, additional leachables data time points, & excipient toxicology risk assessments.
  • The company plans to address all CRL items in its NDA resubmission, including completing required non-clinical studies.
  • Grace Therapeutics is advancing a dual-source manufacturing strategy that includes remediation at its current contract manufacturer & technology transfer to a U.S.-based second source.
  • The resubmission may be supported by either contract manufacturer or both, reducing reliance on a single path.
  • The STRIVE-ON trial showed a 19% reduction in clinically significant hypotension for patients receiving GTx-104 versus oral nimodipine (28% vs 35%).
  • GTx-104 demonstrated higher relative dose intensity (95% or higher in 54% of patients) compared to oral nimodipine (8% of patients).
  • 29% more patients on GTx-104 achieved favorable functional outcomes at 90 days compared to the oral nimodipine arm.
  • No deaths were determined to be related to GTx-104 or oral nimodipine, with all deaths attributed to the severity of the underlying disease.
  • GTx-104 is an injectable formulation of nimodipine for IV infusion in aSAH patients & holds FDA Orphan Drug Designation.