Why Is Neuromuscular Disease Focused Entrada Therapeutics Shares Trading Lower Today?

Entrada Therapeutics Inc TRDA shares are trading lower after the company announced updates on ENTR-601-44 in Duchenne Muscular Dystrophy.

The FDA previously notified Entrada that the Investigational New Drug (IND) application for the Phase 1 clinical trial of ENTR-601-44 had been placed on clinical hold. 

Despite providing additional information to the FDA, the company was informed that the Agency declined to lift the clinical hold. 

The company said the information submitted to the FDA supported initiating the Phase 1 clinical trial in the U.K. in September 2023.

"We are disappointed that the U.S. clinical hold has not been lifted, especially given the strength of the data package submitted to the FDA. It's important to emphasize that the ongoing ENTR-601-44 development program continues to progress, with ENTR-601-44-101 clinical data expected in the second half of 2024. We will re-engage the FDA to discuss next steps in due course," said Dipal Doshi, President and CEO at Entrada Therapeutics.

William Blair writes that Entrada could amend the IND application to go straight into the proposed global multiple-ascending-dose/Phase 2b study in patients.

The analyst notes the disappointment with the clinical hold response while saying it's just a small setback. This decision won't affect the planned timeline for clinical trials, and the company has funding secured until 2025. William Blair maintains an Outperform rating on Entrada.

Price Action: TRDA shares are down 29.9% at $11.69 on the last check Wednesday.