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Design Therapeutics Submitted An Investigational New Drug Application For DT-216P2 With The FDA, The Company Received A Clinical Hold Notice On The IND Application From FDA Noting Nonclinical Deficiencies

Benzinga·06/04/2025 11:05:30
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  • Further details will be provided in an official letter from FDA within 30 days and the company plans to address their questions, once received.
  • IND Application Submitted to Expand RESTORE-FA Trial to U.S. Sites; Notice Received from FDA Placing Clinical Hold on IND Application to Open U.S. Sites