Entrada Therapeutics Shares Tumble 27% After FDA Keeps Clinical Hold

By Colin Kellaher

Entrada Therapeutics shares slid on Wednesday after the biopharmaceutical company said the Food and Drug Administration wouldn't lift the clinical hold it placed on the company's planned study of its Duchenne muscular dystrophy drug candidate.

Shares of the Boston company were recently changing hands at $12.18, down 27%.

The FDA late last year placed the clinical hold on Entrada's application seeking approval to study ENTR-601-44 Duchenne, one of the most severe forms of inherited muscular dystrophies, and the agency asked the company to gather and submit additional information regarding the drug candidate.

According to the FDA's website, subjects can't be given an investigational drug when a proposed study is placed on clinical hold. The agency lists several potential reasons for putting an investigational new drug application on hold, including the possibility that human subjects "would be exposed to an unreasonable and significant risk of illness or injury," or that the application doesn't contain enough information to assess the risks to subjects of the proposed studies.

Entrada on Wednesday said the FDA declined to lift the hold despite the submission of what the company said was a strong data package.

However, Entrada noted that the information it submitted to the FDA supported the launch of a Phase 1 study of ENTR-601-44 in the U.K. in September, and that it has completed dosing for the first and second cohorts in the study.

Entrada said it plans to re-engage the FDA to discuss its next steps in due course, and that it has a cash runway to support its operation through 2025.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

November 22, 2023 11:41 ET (16:41 GMT)

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