
Dyne Therapeutics Inc (NASDAQ:DYN) shares are trading lower by 5.42% to $6.81 after the company announced FDA clearance of its Investigational New Drug application for DYNE-251 for the treatment of Duchenne muscular dystrophy.
Dyne says the company plans to evaluate DYNE-251 in a global, randomized, placebo-controlled, multiple ascending dose (MAD) clinical trial with a long-term extension study. The trial aims to enroll 30 to 50 ambulant and non-ambulant males with Duchenne, who are aged 4 to 16 and have mutations amenable to exon 51 skipping therapy.