08:05 AM EDT, 09/10/2025 (MT Newswires) -- Avidity Biosciences ( RNA ) said Wednesday that new data from 17 DMD44 patients treated continuously with del-zota for one year in a phase 1/2 trial demonstrated reversal of disease progression and "unprecedented" improvement compared to baseline and natural history across multiple endpoints.

DMD44 is a form of Duchenne muscular dystrophy with mutations amenable to exon 44 skipping.

Data from the trial showed that participants treated with del-zota demonstrated "statistically significant" increases of approximately 25% of normal in dystrophin production and over 80% reduction in creatine kinase levels compared to baseline, the company said.

Avidity said it remains on track to submit a biologics license application for del-zota to the US Food and Drug Administration by the end of 2025.

The company said it is also preparing a confirmatory study to support global approval.

Shares of the company were up 1.4% in recent premarket activity Wednesday.