NEW YORK (TheStreet) -- Sarepta Therapeutics (SRPT) shares are up 46.76% to $24.04 in trading on Wednesday after the company announced that it will move forward with its plans to seek regulatory approval for its Duchenne muscular dystrophy treatment eteplirsen this week.
The company's decision to seek regulatory approval came after conferencing with Food and Drug Administration officials in a pre-New Drug Approval (NDA) meeting yesterday where the company was given the green light to file an NDA.
"We will initiate a rolling NDA submission to facilitate the regulatory review of the NDA. The initiation of our NDA submission for eteplirsen marks a significant milestone for the Duchenne community and we look forward to completing the submission by the middle of the year and to continuing to work with the Agency towards the goal of providing treatments to patients as quickly as possible," said interim CEO Edward Kaye, M.D..
Analysts at Baird reacted to the announcement by raising the company's price target to $34 from $20 as it also raised its expectations of the probability of eteplirsen's approval to 35% from 20%.
"We believe the decision to reaffirm their previous timelines without FDA minutes is an indication that this meeting went very well. We do not think it is feasible that management could have misread the agency, given the controversy surrounding their dialogue in the past, and believe the agency is indicating a favorable bias that will result in NDA acceptance and priority review. The company intends to submit the first portions of the submission this week and complete the submission by the middle of this year," said analysts.
TheStreet has further coverage of Sarepta here.