- Dyne Therapeutics has been granted **Orphan Drug designation** by the Ministry of Health, Labour and Welfare (MHLW) in Japan for **DYNE-251**, intended for individuals with **Duchenne muscular dystrophy (DMD)** amenable to exon 51 skipping.  **[1818794_babab93fde474ef68e1eb3a3e3137e8e_0]** 
- This designation provides benefits such as **subsidies for development costs** and potential **market exclusivity for up to 10 years** if approved in Japan.  **[1818794_babab93fde474ef68e1eb3a3e3137e8e_0]** 
- DYNE-251 is currently in the **Phase 1/2 DELIVER global clinical trial**, with results from the Registrational Expansion Cohort anticipated **late 2025**.  **[1818794_babab93fde474ef68e1eb3a3e3137e8e_0]** 
- The therapeutic has also received **Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug designations** from the U.S. FDA and Orphan Drug designation from the European Medicines Agency (EMA).  **[1818794_babab93fde474ef68e1eb3a3e3137e8e_0]** **[1818794_babab93fde474ef68e1eb3a3e3137e8e_1]**

Dyne Therapeutics (DYN)