Dyne Therapeutics, Inc. (DYN) announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to DYNE-101 for the treatment of myotonic dystrophy type 1.
Dyne Therapeutics, Inc. (DYN) is developing DYNE-101, an investigational therapeutic currently under evaluation in the Phase 1/2 global ACHIEVE clinical trial for individuals living with DM1.
The FDA grants Breakthrough Therapy Designation to expedite the development and review of drugs intended to treat serious conditions.
This designation is given when preliminary clinical evidence suggests that the drug may offer substantial improvement over existing therapies on one or more clinically significant endpoints.
Dyne Therapeutics, Inc. (DYN) also announced an updated plan for obtaining U.S. Accelerated Approval for DYNE-101 in DM1 following a Type C meeting with the FDA and analysis of new long-term functional data.
