Dyne Therapeutics reported second quarter 2026 financial results and provided major regulatory updates. The FDA accepted the Biologics License Application (BLA) for z-rostudirsen (DYNE-251) for Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping, granting Priority Review with a PDUFA date of January 21, 2027. The company also completed enrollment for the registrational expansion cohort of the Phase 1/2 ACHIEVE trial for z-basivarsen in DM1, with topline data expected in Q1 2027. Additionally, the FDA cleared the IND for DYNE-302 in FSHD. Financially, Dyne reported a net loss of $178.6 million for the quarter. Following a July 2026 public offering that raised approximately $431 million in gross proceeds, the company reported a cash position of approximately $898.5 million as of June 30, 2026 (pro forma for the offering). Management expects this capital to fund operations into Q2 2028. R&D expenses rose to $152.2 million due to increased manufacturing and clinical costs for its lead programs.