Dyne reports Q3 2026 results as z-rostudirsen BLA review continues toward January 2027 decision

Dyne Therapeutics said on November 5, 2026 that its biologics license application for z-rostudirsen in exon 51 Duchenne muscular dystrophy is under priority review by the FDA, with a target action date under the Prescription Drug User Fee Act set for January 21, 2027.¹ The company said it continues to expect a possible U.S. launch of the drug in the first quarter of 2027 if approved on that schedule.¹ A separate, ongoing Phase 3 study called "FORZETTO" is meant to turn accelerated approval, if granted, into full approval and to back marketing filings outside the U.S., according to the company.

On the myotonic dystrophy type 1 program, Dyne presented additional one-year data from the Phase 1/2 "ACHIEVE" trial of z-basivarsen at two medical meetings in late 2026. Results from a pooled dose group in the multiple ascending dose portion showed improvement compared to baseline, placebo, and a matched natural history group across several measures at the 12-month mark.¹ The company said topline results from the trial's registrational expansion cohort are expected in the first quarter of 2027, intended to support a potential accelerated approval filing in the third quarter of 2027.¹ Dyne said it expects a possible U.S. launch of z-basivarsen in the first half of 2028, assuming the FDA grants priority review and approval arrives on schedule.¹

The company also noted four additional DMD development candidates, DYNE-244, DYNE-245, DYNE-253 and DYNE-255, targeting exon skipping for exons 44, 45, 53 and 55, with supporting preclinical data presented at the Neuromuscular Study Group meeting.¹

On finances, Dyne held $1.134 billion in cash, cash equivalents and marketable securities as of September 30, 2026, which it said should fund operations into the second quarter of 2028.¹ Net loss for the quarter was $193.6 million, or $1.06 per share,¹ up from the prior-year period.