Avidity announces a Managed Access Program for del-zota, for eligible individuals with Duchenne amenable to skipping exon 44

The del-zota Managed Access Program (MAP) is now live on clinicaltrials.gov: 11/26/2025

Letter to the community added: 11/20/2025

Avidity Managed Access Program

As an early funder of Avidity Biosciences, CureDuchenne is so happy to share that Avidity has launched a Managed Access Program (MAP) for its investigational therapy del-zota (delpacibart zotadirsen).  Under an FDA-authorized treatment protocol, individuals with Duchenne who are amenable to skipping exon 44 will be able to be treated via participating healthcare providers.  Enrollment is expected to begin by the end of this year.

CureDuchenne’s goal has always been to help individuals with Duchenne have access to safe and effective treatments.  It was with that goal in mind that we made an investment in Avidity in 2018.  We are so pleased that Avidity is on track to submit for FDA approval in 2026, and that this new program will allow more individuals to have access to del-zota ahead of that process.  We thank both Avidity and the FDA for making this happen.  

Additional information about the MAP, including eligibility criteria, will be available on www.clinicaltrials.gov

Study Details | NCT07250737 | Managed Access Program for Del-zota in Participants With DMD Mutations Amenable to Exon 44 Skipping | ClinicalTrials.gov

Link to press release:  https://investors.aviditybiosciences.com/2025-11-19-Avidity-Biosciences-Announces-U-S-Managed-Access-Program-MAP-for-Investigational-Therapy-del-zota-in-DMD44

Letter to the community:

Related Posts

Share This Page

Make an Impact

You can advance the care, treatment and cure for Duchenne muscular dystrophy. Contributions in any amount can truly make a difference and can be credited to a fundraiser or event from the list below.

Donate