Edgewise's Inherited Neuromuscular Disorder Candidate Receives FDA Fast Track Tag

by Vandana Singh, Benzinga Editor

August 16, 2021 12:30 PM | 1 min read | Make a Comment

The FDA has granted Fast Track designation to Edgewise Therapeutics Inc's EWTX EDG-5506 for Becker Muscular Dystrophy (BMD).
EDG-5506, a selective, small molecule myosin inhibitor designed to protect injury-susceptible fast skeletal muscle fibers in DMD and BMD.
The candidate is advancing in the Phase 1 clinical trial.
The Company expects to have Phase 1 topline Multiple Ascending Dose (MAD) data in healthy volunteers and individuals with BMD later in 2021.
BMD is an inherited neuromuscular disorder that results from truncation or mutation of the X-linked dystrophin gene yielding unstable and/or dysfunctional dystrophin expression in muscles.
Price Action: EWTX shares are down 0.31% at $16.21 during the market session on the last check Monday.
Related content: Benzinga's Full FDA Calendar.