Dyne Therapeutics reported third-quarter 2026 results alongside progress toward two potential drug launches and updates on its Duchenne muscular dystrophy and myotonic dystrophy programs. Its lead Duchenne candidate, z-rostudirsen, is under priority review by the FDA, while the company plans to report a key set of trial results for its myotonic dystrophy candidate in early 2027.
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Z-rostudirsen for Duchenne: The FDA’s target date for an action on the drug’s application is January 21, 2027. Dyne expects a possible U.S. launch in the first quarter of 2027 if the drug is approved on that timeline. The ongoing Phase 3 FORZETTO trial is intended to support a move from any accelerated approval to traditional approval and to support applications outside the U.S.
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More Duchenne programs: Dyne is advancing four preclinical candidates aimed at Duchenne mutations that can be addressed by skipping exons 44, 45, 53 or 55. The company says these programs could extend its reach to more than one-third of people with Duchenne.
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Z-basivarsen for myotonic dystrophy type 1: Additional one-year results from the Phase 1/2 ACHIEVE trial showed functional improvement at 12 months across multiple measures, compared with participants’ starting points, placebo and a matched natural-history group. The release did not provide numerical effect sizes for these comparisons.
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Upcoming z-basivarsen milestones: Dyne expects topline results from ACHIEVE’s registrational expansion cohort in the first quarter of 2027. It plans to use those results, along with data from other ACHIEVE participants, to support a potential U.S. application for accelerated approval in the third quarter of 2027. A potential U.S. launch is anticipated in the first half of 2028, assuming priority review and approval on the expected timeline. The ongoing Phase 3 HARMONIA trial is intended to support traditional approval if accelerated approval is granted, as well as applications outside the U.S.
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Cash and research spending: Dyne had $1.134 billion in cash, cash equivalents and marketable securities at September 30, 2026. The company expects those funds to support operations into the second quarter of 2028. Research and development expense was $161.7 million for the quarter, up from $97.2 million a year earlier—an increase of $64.5 million, or about 66%.
The disclosed timelines put z-rostudirsen closest to a potential commercial launch, while z-basivarsen’s next major step is the planned early-2027 trial readout. The cash runway estimate extends beyond both anticipated launch windows, based on the company’s current expectations.