In a recent public statement, Sarepta Therapeutics Inc (NASDAQ:SRPT) announced that it had not received new drug review date from FDA advisory panel. In addition to uncertainty over review date, Sarepta also made clear that it would cut about 17% jobs to handle financial charges.
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The initial meeting with regard to Sarepta’s drug, eteplirsen, was supposed to take place on January 20, 2016; however, FDA postponed it due to bad weather conditions in Washington. Sarepta believes that the next review meeting will most likely take place on or before May 26 deadline, which is the deadline given by FDA for the review.
Sarepta designed eteplirsen to treat Duchenne muscular dystrophy patients; however, the FDA team evaluating this drug wasn’t convinced about its effectiveness. According to FDA staff, Sarepta needed to improvise the drug, so that it could have a better impact on patients suffering from Duchenne muscular dystrophy.
Meanwhile, Sarepta announced that it would shut down Corvallis, Oregon unit due to inefficient business opportunities. It would relocate some employees and research activities to another facility located in Andover and Cambridge, Massachusetts. Over 17% of its workforce will lose jobs due to this business restructuring activity. It had 270 employees as of the annual report filed on December 31, 2015.
It believes that relocation of the workforce to Massachusetts will improve the overall operational efficiency in the long term. According to company’s CMO & Interim CEO, Edward Kaye, it’s very important for a company like Sarepta to centralize its manufacturing, R&D and pre-commercialization activities, and this restructuring initiative will help it do so. The impacts of this decision may not be visible immediately, but they will surely help the company forge ahead in the long run.
Going forward, it will take many more such initiatives to make eteplirsen a huge success across the globe. More details about these initiatives will be announced at a later date.