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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