Sarepta Therapeutics Inc (NASDAQ: SRPT) Soars 60%
Shares of SRPT surged higher by over 60% in yesterday’s trading after the company announced it had initiated the process of attaining regulatory approval for their lead drug candidate, Eteplirsen, which treats muscular dystrophy, a rare disorder. SRPT expects to finalize the New Drug Application, or NDA, by the third quarter of 2015.
Edward Kaye, SRPT’s interim Chief Executive Officer said, “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 [FDA] towards the goal of providing treatments to patients as quickly as possible.”
Analyst Comments
Adam Walsh, an analyst out of Cannacord Genuity upgraded SRPT to Buy from Neutral and boosted his price target to $33 from $14.
Christopher Marai, an analyst out of Oppenheimer reiterated his Outperform rating as well as a $45 price target.
According to analysts at Baird, “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.” Baird analysts also boosted their price target on SRPT to $34 from $20.
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About SRPT
Sarepta Therapeutics, Inc., a biopharmaceutical company, focuses on the discovery and development of RNA-based therapeutics for the treatment of rare, infectious, and other diseases. Its lead product candidate is Eteplirsen, an antisense phosphorodiamidate morpholino oligomer therapeutic, which is in Phase III clinical development stage for the treatment of individuals with Duchenne muscular dystrophy (DMD), a rare genetic muscle-wasting disease caused by the absence of dystrophin. The company also focuses on developing therapeutics for the treatment of drug-resistant bacteria, Becker muscular dystrophy, progeria, adult onset pompe, lupus and graft-versus-host diseases; and other rare, genetic, anti-infective, neuromuscular, and central nervous system diseases. The company is also involved in developing treatments that are in Phase I clinical trials for infectious diseases, including AVI-7288 for Marburg virus; and AVI-7100 for H1N1 influenza virus. Sarepta Therapeutics, Inc. was founded in 1980 and is headquartered in Cambridge, Massachusetts. – Yahoo! Finance
