Avidity Biosciences (RNA) said Wednesday it plans to file a biologics license application for delpacibart zotadirsen, or del-zota, for patients with Duchenne muscular dystrophy mutations amenable to exon 44 skipping for year end.

The US Food and Drug Administration confirmed the accelerated approval path is available for del-zota and that the clinical data package from the EXPLORE44 program could support a BLA filing, the company said.

"We look forward to an exciting year ahead as we prepare to become a commercial organization," said Chief Executive Officer Sarah Boyce.

Avidity also said it is on track to complete enrollment in del-desiran HARBOR Phase 3 and potential registrational del-brax biomarker cohort as well as initiate global pivotal trial for del-brax by mid-2025.

The company said Eric Mosbrooker expanded his role to chief commercial officer to lead its multiple product launches. It also said Charles Calderaro III has joined the firm as chief technical officer, and Kat Lange as chief business officer.

Price: 30.83, Change: +0.04, Percent Change: +0.13