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BioWorld - Thursday, July 9, 2026
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Home » Dyne seeks accelerated path on positive dystrophy data; shares down
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Dyne seeks accelerated path on positive dystrophy data; shares down

Jan. 10, 2025
By Lee Landenberger
Dyne Therapeutics Inc. is eyeing accelerated approval for its myotonic dystrophy type 1 treatment after reviewing new results from a phase I/II study. DYNE-101, an oligonucleotide antisense and DMPK gene modulator, produced results on disease biomarkers that included DMPK and splicing correction, disease progression reversal on several functional endpoints and a favorable safety profile. The accelerated approval submission could come in the first half of 2026.
BioWorld Clinical Regulatory Endocrine/metabolic Antisense FDA

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