Sarepta Therapeutics Inc.
SRPT,
which yesterday scored a win with U.S. Food and Drug Administration approval of the first gene therapy for children with Duchenne muscular dystrophy, was downgraded Friday by analysts who are skeptical that Sarepta can expand the treatment’s narrow label. The treatment, Elevidys, was approved under the FDA’s accelerated approval pathway, which gives patients access to promising new treatments while the company conducts trials to confirm the expected clinical benefit. Elevidys was approved for a narrow population of four- and five-year-old children, and Sarepta will need positive phase 3 trial data to expand the label, Evercore ISI analysts wrote in a note Friday. While data will likely be strong enough to maintain the current narrow indication, “we just think the path to expand the label is tough,” the analysts wrote in the note, downgrading the stock to in line from outperform and trimming their price target to $139, from $151 previously. Sarepta shares gained 1.7% in premarket trading Friday.
