By Kelly Cloonan
Shares of Sarepta Therapeutics rose after the Food and Drug Administration accepted the company's supplemental new drug applications for two treatments for Duchenne muscular dystrophy.
The stock gained 5.4% to $17.93 in midday trading on Tuesday. Shares are down 17% this year.
Sarepta said the FDA has assigned a Prescription Drug User Fee Act target action data of Feb. 28, 2027 for the treatments, Amondys 45 and Vyondys 53.
The submissions seek to convert the accelerated approvals of the drugs to traditional approvals, the company said.
Analysts at Mizuho view the FDA filing acceptance as positive news, given investor concerns that the regulatory path forward could be limited after a Phase 3 trial evaluating the treatments failed to achieve statistical significance.
"We continue to believe the risk of Amondys 45/Vyondys 53 being withdrawn from the market remains low, given the clinical benefits demonstrated with real-world evidence and the ultra-rare nature of the exon 45 and exon 53 amenable DMD patient populations," the analysts said in a note.
Duchenne muscular dystrophy is a progressive, genetic neuromuscular disorder that results in progressive muscle degeneration and weakness.
Write to Kelly Cloonan at kelly.cloonan@wsj.com