Sarepta CEO Exits, Eteplirsen Regulatory Filing on Track

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Sarepta Therapeutics, Inc. SRPT announced that its President and Chief Executive Officer (CEO), Christopher Garabedian, has stepped down from his position and resigned from the company’s board with immediate effect. The news comes just months before the company prepares to file for its Duchenne muscular dystrophy (DMD) candidate, eteplirsen’s approval in the U.S. Sarepta, however, did not cite any reason for his resignation.

Sarepta’s current Chief Medical Officer (CMO) Edward Kaye has taken over in the meanwhile as the CEO of the company until a permanent CEO is appointed. We note that Edward Kaye has occupied the post of Sarepta’s CMO since Jun 2011. During his tenure as a CMO, he was responsible for the company’s medical and clinical operations. Prior to joining Sarepta, he had worked in Genzyme, which is a subsidiary of Sanofi SNY now.

Sarepta declared in its press release that it remains on track to file a new drug application for eteplirsen in the U.S. in mid-2015. We note that eteplirsen, the company’s lead pipeline candidate, is being developed for the treatment of DMD.

DMD, a devastating and debilitating disease, is estimated to affect nearly 1 in every 3,500 boys born across the world. There is significant unmet need for DMD treatments. Eteplirsen has the potential to address up to 13% of the total DMD population.

We remind investors that BioMarin BMRN has already started the rolling NDA submission for its DMD candidate, drisapersen in the U.S. and expects to complete the submission shortly.

With no approved product in Sarepta’s portfolio at the moment and eteplirsen being the company’s lead pipeline candidate, we expect investor focus to remain on updates pertaining to its development.

Sarepta currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Horizon Pharma plc HZNP carrying a Zacks Rank #1 (Strong Buy).

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