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Avidity Biosciences

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FDA designations

  • Avidity Biosciences Receives FDA Breakthrough Therapy Designation for Delpacibart Zotadirsen (del-zota) for the Treatment of DMD in People with Mutations Amenable to Exon 44 SkippingJul 23, 2025

News

  • Atrium Therapeutics received FDA IND clearance for ATR 1072 in PRKAG2 syndromeJul 14, 2026
  • Avidity Biosciences' Del-zota demonstrated reversal of disease progression across key functional endpoints in EXPLORE44® and EXPLORE44-OLE™ Phase 1/2 trial in people living with DMD44Sep 10, 2025
  • Avidity Biosciences announces completion of enrollment for HARBOR™, the first global Phase 3 trial of Delpacibart Etedesiran (del-desiran) for treatment of DM1, and provides regulatory submission guidanceJul 28, 2025
  • Avidity Biosciences receives FDA Breakthrough Therapy designation for Delpacibart Zotadirsen (del-zota) to treat Duchenne muscular dystrophy in patients with exon 44 skipping mutationsJul 23, 2025
  • Avidity Biosciences to present topline results from Phase 1/2 FORTITUDE™ trial in FSHD at upcoming international research congressJun 12, 2025

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