Entrada Therapeutics announced that the company received a clinical hold notice from the FDA regarding their Investigational new drug application, or IND, for ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy. The FDA indicated they will provide an official Clinical Hold letter to Entrada within 30 days. The company plans to share additional updates pending further communications with the Agency. "The clinical hold on our ENTR-601-44 program is disappointing and we will work to address the FDA’s concerns regarding the IND," said Dipal Doshi, president and CEO of Entrada Therapeutics. "There are no approved Duchenne therapies for people with exon 44 skippable mutations and we are eager to resolve this hold and continue down the treatment development pathway."
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