Entrada: FDA Declines to Lift Hold on Duchenne Study
22 Novembro 2023 - 9:54AM
Dow Jones News
By Colin Kellaher
Entrada Therapeutics on Wednesday said the U.S. Food and Drug
Administration declined to lift the clinical hold on a planned
study of ENTR-601-44 as a potential treatment of Duchenne muscular
dystrophy.
The Boston clinical-stage biopharmaceutical company said it is
disappointed by the FDA's decision, citing the strength of a data
package it submitted to the agency after the hold was implemented
late last year.
Entrada said the information it submitted to the FDA supported
the initiation of a Phase 1 study in the U.K. in September, and
that it has completed dosing for the first and second cohorts in
the study, with plans to announce data in the second half of
2024.
Entrada said it continues to plan for the global development of
ENTR-601-44, adding that it will re-engage the FDA to discuss its
next steps in due course.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 22, 2023 07:39 ET (12:39 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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