09:45 AM EDT, 10/13/2025 (MT Newswires) -- Avidity Biosciences ( RNA ) said Monday it completed a "positive" pre-biologics license application meeting with the US Food and Drug Administration for its drug candidate delpacibart zotadirsen, or del-zota, to potentially treat Duchenne muscular dystrophy patients with exon 44 mutations.

The company said it now plans to submit the BLA in Q1 2026, later than the prior forecast of year-end 2025, to include additional data for the chemistry, manufacturing, and controls package.

Avidity said del-zota received breakthrough therapy designation and that a confirmatory study is being prepared to support global approval.

The planned filing will be the first of three BLA submissions expected over 12 months, the company said.

Shares of the company were up 1.7% in early Monday trading.

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