Sarepta CEO resigns as company looks to renewed focus on gaining eteplirsen approval

Sarepta Therapeutics announced that CEO Christopher Garabedian resigned with immediate effect, with chief medical officer Edward Kaye appointed to the role on an interim basis. The company said that Kaye "will focus his efforts" on heading the regulatory and clinical process for Duchenne muscular dystrophy (DMD) therapy eteplirsen.

In October last year, shares in Sarepta fell up to 40 percent after announcing that it plans to seek FDA approval of eteplirsen by mid-2015, delayed from a previous timeline of the end of 2014. At the time, the drugmaker noted that the regulator asked for further data to be included in the filing. Kaye said that Sarepta is "on track in collecting and analysing the data requested by the FDA" in order to submit an application "in the middle of this year as planned."

John Hodgman, Sarepta's interim board chairman, said the change in CEO "will facilitate the company's clinical and regulatory discussions and relationships." Hodgman remarked that Kaye "has excellent relationships with the clinical, regulatory and patient advocacy communities so critical to making this treatment a reality." The drugmaker indicated that it will conduct a search for a new full-time CEO.

Commenting on the news, RBC Capital analyst Simos Simeonidis said it is "an incremental net positive for Sarepta, since we expect the change at the CEO position can help with improving the company's problematic interactions with FDA, and its credibility with investors." Simeonidis added that "Kaye's background as a paediatric neurologist with industry experience in rare disease drug development at Genzyme definitely brings a different gravitas to the role."

For related analysis, see ViewPoints: Drop off in effect of eteplirsen may prolong – but not block – Sarepta’s path to market.

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