17 June 2025 - - Dyne Therapeutics today announced that the US FDA has granted breakthrough therapy designation to DYNE-101 for the treatment of myotonic dystrophy type 1. 

The company also announced an updated plan for obtaining US accelerated approval for DYNE-101 in DM1 following a type C meeting with the FDA and analysis of new long-term functional data.

Read Dyne Therapeutics press release