Approval PathwaysRNA has confirmed with the FDA that the accelerated approval path is available for del-zota and the clinical data package can support a BLA filing.
Clinical TrialsThere is strong interest in enrollment for the DM1 phase 3 study, with completion on track, demonstrating confidence in the program.
Regulatory ProgressRNA is effectively engaging with FDA and global regulators on the FSHD regulatory path, indicating proactive management.