Entrada Therapeutics Shares Tumble 27% After FDA Keeps Clinical Hold
22 Novembro 2023 - 1:56PM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 22, 2023 11:41 ET (16:41 GMT)
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