Trial Profile

A Phase 2 Open-label Study to Evaluate the Pharmacodynamics and Long-Term Safety and Tolerability of AOC 1044 Administered Intravenously to DMD Participants With Mutations Amenable to Exon 44 Skipping

Status: Active, no longer recruiting

Phase of Trial: Phase II

Latest Information Update: 13 Nov 2025

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At a glance

13 Oct 2025 According to an Avidity Biosciences media release, the company announced that it has completed a positive pre-BLA meeting with the FDA regarding its upcoming BLA submission of delpacibart zotadirsen (del-zota). The timing for the BLA submission has been updated to Q1 2026 from previous guidance of year end 2025 to ensure the FDA receives additional data to support the chemistry, manufacturing, and controls (CMC) package at time of submission.
10 Sep 2025 Results presented in an Avidity Biosciences media release.
14 May 2025 Planned End Date changed from 31 Dec 2026 to 31 Jul 2027.

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