“Our lead programs in DMD and DM1 have now each been granted Breakthrough Therapy Designation by the FDA and are advancing toward anticipated U.S. Accelerated Approval submissions, as we aim to further validate the potential of our FORCE platform to safely and effectively deliver multiple drug payloads broadly and deeply into muscle and the CNS. We believe z-rostudirsen has the potential to transform the lives of individuals living with DMD amenable to exon 51 skipping, and we are excited to share topline data in December,” said John Cox, president and chief executive officer of Dyne.
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