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
Author: Benzinga Newsdesk | June 04, 2025 06:05am
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