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

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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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Posted-In: Briefs central nervous system disordersBiotech News Health Care Small Cap FDA General

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