Entrada Therapeutics Inc TRDA shares are trading lower in Monday’s after-hours session after the company said it received a clinical hold notice from the U.S. Food and Drug Administration.
What Happened: Entrada received a clinical hold notice from the FDA regarding its Investigational New Drug Application for ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy.
The FDA said they would provide an official clinical hold letter to Entrada within 30 days.
“The clinical hold on our ENTR-601-44 program is disappointing and we will work to address the FDA’s concerns regarding the IND. 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,” said Dipal Doshi, president and CEO of Entrada.
Entrada is a biopharmaceutical company that aims to transform the lives of patients by establishing a new class of medicines to engage intracellular targets that have long been considered inaccessible.
TRDA Price Action: Entrada shares are down 32.10% in after hours at $13.50 at the time of publication, according to Benzinga Pro.
Photo: Michal Jarmoluk from Pixabay.