Dyne's Shares Gain After FDA Removed Clinical Hold On Muscular Disease Study

Dyne Therapeutics DYN announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and cleared its Investigational New Drug (IND) application to initiate a clinical trial of its drug DYNE-25.

The Phase 1/2 clinical trial will investigate DYNE-251 in patients with Duchenne muscular dystrophy (DMD), dosing is expected to begin in mid-2022.

The company plans to evaluate DYNE-251 in a global multiple ascending dose (MAD) clinical trial with a long-term extension study by enrolling 30 to 50 ambulant and non-ambulant males with Duchenne.

Joshua Brumm, president and chief executive officer, said, “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.”

Duchenne muscular dystrophy (DMD) is a rare disease caused by mutations in the gene that encodes for dystrophin, a protein critical for the normal function of muscle cells.

Dyne Therapeutics Shares are trading up 8 percent at $7.76 last check on Tuesday.