Dyne Therapeutics announces Z-rostudirsen remains on track for 1Q27 launch

Z-rostudirsen remains on track for potential launch in Q1 2027: Dyne continues to anticipate a potential BLA submission for U.S. Accelerated Approval in Q2 2026. Dyne continues to expect a potential U.S. launch of z-rostudirsen in Q1 2027, assuming FDA grants Priority Review. Dyne also continues to pursue approval pathways outside of the U.S. for z-rostudirsen in patients with DMD who are amenable to exon 51 skipping.