Dyne Therapeutics Secures Orphan Drug Designation in Japan for DYNE-251 in Duchenne Muscular Dystrophy
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Dyne Therapeutics has received Orphan Drug designation in Japan for its investigational therapy DYNE-251, aimed at treating Duchenne muscular dystrophy (DMD) patients with specific mutations. This designation offers benefits such as development cost subsidies and potential market exclusivity for up to 10 years. DYNE-251 is currently in the Phase 1/2 DELIVER trial, showing sustained functional improvement. The therapy also holds multiple designations from the U.S. FDA and EMA. Results from the trial's expansion cohort are anticipated in late 2025.
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