Dyne Therapeutics (DYN) received orphan drug designation from the European Commission for its candidate drug DYNE-251 to treat Duchenne muscular dystrophy.
The drug is being assessed in phase 1/2 of a global trial in people with the disease who are amenable to exon 51 skipping, the company said Thursday in a statement.
"With full enrollment of the registrational expansion cohort in the DELIVER trial complete, we look forward to sharing data from this cohort in late 2025 and the potential to move forward with our first regulatory submissions in early 2026," Dyne Chief Medical Officer Doug Kerr said.
Dyne shares rose 3.1% in recent Thursday trading.
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