Entrada Therapeutics Receives FDA Hold Notice For Duchenne Muscular Dystrophy Drug; Stock Tanks 30%

(RTTNews) - Shares of Entrada Therapeutics, Inc. (TRDA) tanked nearly 30% in extended session on Monday after the company announced that FDA has put a clinical hold on IND application for ENTR-601-44 in Duchenne Muscular Dystrophy.

Entrada Therapeutics announced that the company received a clinical hold notice from the FDA regarding their Investigational New Drug Application (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 Chief Executive Officer 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."