Dyne Shares Fall After Clinical Hold for DYNE-251 in Duchenne Muscular Dystrophy
January 18 2022 - 9:12AM
Dow Jones News
By Michael Dabaie
Dyne Therapeutics Inc. shares fell 14%, to $8, premarket after
the company said it got a clinical hold from the FDA on the
application for DYNE-251 in Duchenne muscular dystrophy.
The company said the U.S. Food and Drug Administration placed on
clinical hold its investigational new drug application to initiate
a clinical trial of DYNE-251.
Dyne said it received a clinical hold letter from the FDA on
Friday, requesting additional clinical and non-clinical information
for DYNE-251. The company said it expects to submit to the FDA its
response with data from existing and ongoing studies in the second
quarter of 2022.
If that is satisfactory to the FDA, the company said it expects
to be dosing patients in a Phase 1/2 clinical trial of DYNE-251 by
mid-2022 in accordance with its current guidance.
The company said expects to submit an IND for DYNE-101 in
myotonic dystrophy type 1 during the first quarter of 2022 and to
be dosing patients in a planned clinical trial by mid-2022.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
January 18, 2022 08:57 ET (13:57 GMT)
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