Sarepta Therapeutics (NASDAQ) saw its shares soar 32% at market open on Friday following the FDA’s expanded approval of its drug, ELEVIDYS, for Duchenne muscular dystrophy (DMD). The drug is now fully approved for ambulatory patients aged 4 and above, with conditional approval for non-ambulatory patients, pending further research.
“This was the home-run scenario,” commented Piper Sandler analysts, reiterating their Overweight rating. Sarepta’s CEO, Doug Ingram, hailed the approval as a milestone for gene therapy and the DMD community.
Sarepta will conduct further studies to confirm ELEVIDYS’s benefits for non-walking patients, with ongoing collaboration with Roche for global distribution.
