The US Food and Drug Administration (FDA) recently granted fast track status to Sarepta Therapeutics, Inc.’s (SRPT) candidates, AVI-7288 and AVI-7537. The designation has been granted to the candidates, AVI-7288 and AVI-7537, for the treatment of infectious diseases caused by Marburg virus and ebola virus, respectively.
We note Sarepta is developing the platform-based therapeutics under the US Department of Defense (DoD) contract. The contract is managed by the Joint Project Manager Transformational Medical Technologies (JPM-TMT) Project Management Office.
The fast track program not only facilitates the development but also expedites the review of drugs which are developed for treating serious diseases. Such diseases are usually characterized by a huge unmet medical need.
The receipt of such a designation from the FDA ensures frequent communication with the US regulatory body during the drug development and review process. The frequent dialogue ensures quicker resolution of the FDA’s queries regarding the drug, often leading to faster approval.
Sarepta is currently evaluating the safety and efficacy of AVI-7288 in pre-clinical studies for the treatment of hemorrhagic fever, caused by Marburg virus. The company also plans to commence a phase I study at various dosages for characterizing the safety, tolerability and pharmacokinetics of the candidate.
At present, the ebola programs of JPM-TMT, which includes AVI-7537, are halted due to a lack of funds.
Sarepta Therapeutics, a biopharmaceutical company, is focused on the development of first-in-class RNA-based therapeutics for the treatment of serious and life-threatening, uncommon and infectious diseases.
The company's lead candidate eteplirsen is currently in clinical studies for the treatment of Duchenne muscular dystrophy. Sarepta expects to begin patient enrollment of a pivotal phase III study of eteplirsen in late 2013.
Our Recommendation
Currently, we have a Neutral recommendation on Sarepta Therapeutics, Inc. However, the stock carries a Zacks #2 Rank (Buy rating) in the short run.
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