Dyne reports Q2 2026 results as FDA accepts BLA for z-rostudirsen

Dyne Therapeutics said on July 29, 2026 that the FDA accepted its BLA for z-rostudirsen for review in July 2026 and granted Priority Review, with a PDUFA target action date of January 21, 2027.¹ The company said it continues to expect a potential U.S. launch of z-rostudirsen in Q1 2027, assuming approval on the anticipated timeline.¹ Dyne also noted it initiated the global confirmatory Phase 3 FORZETTO trial of z-rostudirsen in May 2026.¹

In its DM1 program, Dyne completed enrollment of 71 participants in the registrational expansion cohort of the ACHIEVE trial in June 2026.¹ The company also started dosing patients in July 2026 in its global Phase 3 trial for z-basivarsen, called HARMONIA.¹ Topline data from the ACHIEVE expansion cohort are planned for Q1 2027 to support a potential BLA submission for U.S. Accelerated Approval in Q3 2027.¹ Dyne said it expects a potential U.S. launch of z-basivarsen in H1 2028, assuming the FDA grants Priority Review and approval comes on schedule.¹

For FSHD, the FDA cleared Dyne's IND application in July 2026, allowing the company to start a Phase 1 trial of DYNE-302.¹ That trial is designed as a randomized, placebo-controlled, double-blind, multiple ascending dose study in ambulatory adults with FSHD, with safety and tolerability as the primary endpoint.¹

On financing, Dyne expanded its non-dilutive term loan facility with Hercules Capital, Inc. to up to $400 million through an amendment signed in June 2026.¹ It also sold 21,045,000 shares in an underwritten public offering priced at $20.50 per share in July 2026, raising about $431 million in gross proceeds.¹ As of June 30, 2026, the company reported cash, cash equivalents and marketable securities of $898.5 million,¹ and said this, combined with the July offering proceeds, is expected to fund operations into the second quarter of 2028.¹