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.
"Today marks a significant step in our journey to build a DMD franchise to serve people across the globe with Duchenne mutations amenable to exon skipping. The clearance of our first IND is an important achievement for Dyne, and we appreciate the partnership with the FDA throughout this process. Our team has worked extensively with key opinion leaders, patient advocacy groups and individuals living with DMD to thoughtfully design and execute our global multiple-ascending dose Phase 1/2 clinical trial of DYNE-251," said Joshua Brumm, president and chief executive officer of Dyne.
According to data from Benzinga Pro, Dyne Therapeutics has a 52-week high of $21.70 and a 52-week low of $4.30.
