FDA grants Breakthrough Therapy designation to Avidity's del-zota for DMD44

Avidity Biosciences, Inc.

Delpacibart zotadirsen (del-zota) receives Breakthrough Therapy designation for Duchenne muscular dystrophy amenable to exon 44 skipping.
Avidity remains on track to submit a BLA for del-zota by year end 2025.
Breakthrough Therapy designation may expedite development and review; does not guarantee approval.
Designation based on clinical data; no financial details or additional program updates provided.

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