NasdaqGM:RNABiotechs
Will FDA Accelerated Pathway for Delpacibart Zotadirsen Reshape Avidity Biosciences' (RNA) Rare Disease Trajectory?
In November 2025, Avidity Biosciences announced the launch of its Managed Access Program for the investigational therapy delpacibart zotadirsen for eligible Duchenne muscular dystrophy (DMD44) patients in the United States, aligning with the FDA on a 2026 accelerated approval submission pathway.
This move reflects significant clinical and regulatory progress, as the therapy has earned multiple expedited designations from both U.S. and European regulators.
We'll explore how securing FDA...