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Thursday, April 23, 2026

CRL for Grace Therapeutics' GTx-104 NDA citing CMC and non-clinical issues

 

FDA issues Complete Response Letter for Grace Therapeutics' GTx-104 NDA citing CMC and non-clinical issues

  • FDA letter cites CMC and non-clinical issues but does not request any additional clinical data for GTx-104.
  • Grace Therapeutics plans to resubmit the GTx-104 NDA to address the Complete Response Letter deficiencies.
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