Avidity Biosciences (RNA) announced that the company completed a positive pre-BLA meeting with the U.S. FDA regarding its upcoming BLA submission of delpacibart zotadirsen. Del-zota, which received Breakthrough Therapy designation, is an investigational drug being evaluated as a potential treatment for people living with Duchenne muscular dystrophy who have gene mutations amenable to exon 44 skipping. The timing for the BLA submission has been updated to Q1 2026 from previous guidance of year end 2025 to ensure the FDA receives additional data to support the chemistry, manufacturing, and controls package at time of submission.
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