Avidity Biosciences Announces US Managed Access Program for Investigational Therapy del-zota in DMD44.

Avidity Biosciences announced a Managed Access Program (MAP) for investigational therapy del-zota for Duchenne muscular dystrophy mutations amenable to exon 44 skipping (DMD44) in the US. The program aims to provide eligible patients with access to del-zota as quickly as possible, with enrollment anticipated to begin by year-end. The FDA has authorized the treatment protocol, and Avidity plans to submit a Biologics License Application (BLA) for accelerated approval in 2026.