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


Benzinga | Aug 16, 2021 12:30PM EDT

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

* The FDA has granted Fast Track designation to Edgewise Therapeutics Inc's (NASDAQ: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.







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