NEW YORK, January 4, 2026, 13:49 ET — Market closed
- Dyne Therapeutics shares closed down 5.5% on Friday at $18.50.
- The company is targeting a Q2 2026 U.S. accelerated-approval filing for its Duchenne drug.
- The next earnings report is listed for Feb. 26, with investors watching spending needs ahead of a planned Phase 3 start.
Dyne Therapeutics shares closed down 5.5% on Friday at $18.50, ending the first U.S. trading session of 2026 on a softer note. About 2.65 million shares changed hands.
The pullback matters because 2026 is shaping up as a timing-driven year for the clinical-stage biotech, with investors focused on whether its lead Duchenne muscular dystrophy program can reach regulators on schedule and on what that path costs.
Dyne said in December its Phase 1/2 DELIVER trial met its main biomarker goal, lifting dystrophin — a muscle protein missing in Duchenne — to 5.46% of normal at six months, and it reiterated a plan to file for U.S. accelerated approval in the second quarter of 2026. Accelerated approval is an FDA pathway that can clear drugs based on a marker that is reasonably likely to predict benefit, rather than waiting for longer-term outcomes; a BLA, or Biologics License Application, is the approval filing. “I am highly encouraged by these new results,” said Perry Shieh, a UCLA neurologist and a principal investigator on the trial. GlobeNewswire
The company’s drug, z-rostudirsen (also called DYNE-251), targets patients amenable to exon 51 skipping — a genetic approach that helps cells “skip” over a faulty part of a gene to make a shorter, functional protein. Dyne has said it expects to start a global Phase 3 trial in the second quarter of 2026 and is aiming for a potential U.S. launch in the first quarter of 2027 if the FDA grants priority review. GlobeNewswire
Dyne’s update put its program squarely into a competitive corner of Duchenne, where the U.S. already has an exon 51-skipping therapy on the market. Sarepta Therapeutics’ Exondys 51 (eteplirsen) is approved under accelerated approval based on increased dystrophin, with continued approval contingent on confirmatory trials.
Another peer in muscle-targeted RNA drugs is Avidity Biosciences, which is also developing antibody-oligonucleotide conjugates in muscle diseases including myotonic dystrophy type 1 and Duchenne.
Dyne bolstered its balance sheet in December with an upsized public offering: 21.83 million shares at $18.44 per share, raising roughly $402.5 million in gross proceeds. GlobeNewswire
Friday’s close leaves the stock trading roughly in line with that $18.44 offering price, after a volatile December. Shares touched an intraday high of $23.96 on Dec. 8, then fell nearly 17% the next day as the financing was announced.
The company has not released fresh corporate news since late December, its website’s “Latest news” section shows, leaving the stock to trade largely on broader risk appetite and positioning into the new year. Dyne Therapeutics
But the downside case remains clear: accelerated approval rests on regulators’ comfort with dystrophin as a surrogate and with the durability of functional signals, while any safety surprises, trial delays or higher-than-expected spending could pressure the timeline and increase dilution risk.
