Expanded US FDA approval of Elevidys in DMD

US precision genetic medicines firm Sarepta Therapeutic (Nasdaq: SRPT) saw its close up 5% and soar a further 36.5% to $168.55 in after-hours activity, as it revealed a welcome indication extension for its Duchenne muscular dystrophy (DMD) drug.

The US Food and Drug Administration (FDA) approved an expansion to the labeled indication for Elevidys (delandistrogene moxeparvovec-rokl) to include individuals with DMD with a confirmed mutation in the DMD gene who are four years of age and above, regardless of ambulatory status.

This decision comes almost one year to the day since the FDA granted accelerated approval of Elevidys to treat ambulatory patients with Duchenne, restricting the ages four through five years only.