Dyne Therapeutics (DYN) announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track designation for DYNE-101 for the treatment of myotonic dystrophy type 1. DYNE-101 is currently being evaluated in the ongoing Phase 1/2 ACHIEVE global clinical trial. “This Fast Track designation comes on the heels of robust clinical data from our ACHIEVE trial, which demonstrated substantial functional benefit for patients across a range of clinical measures and a compelling effect on the key disease biomarker of splicing correction,” said Doug Kerr, M.D., Ph.D., chief medical officer of Dyne.
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