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What Does Sarepta's Big CEO Shakeup Mean?

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Sarepta Says FDA Postpones Advisory Committee Meeting to Review Eteplirsen Due to Severe Weather Storm in the Washington D.C.

In a report published Wednesday, RBC Capital Markets analyst Simos Simeonidis maintained a Sector Perform rating on Sarepta Therapeutics, Inc (NASDAQ: SRPT), after Chris Garabedian resigned as the company's CEO and a Board member with immediate effect. CMO Ed Kaye has stepped in as interim CEO.

Simeonidis views the news as "an incremental net positive" for the company. The change at the CEO position may help smooth out Sarepta's "problematic interactions" with the FDA, while also helping to improve the company's credibility with investors.

"Dr. Kaye's background as a pediatric neurologist with industry experience in rare disease drug development at Genzyme definitely brings a different gravitas to the role," the analyst wrote.

Although Mr. Garabedian's regulatory interactions had been criticized by investors, the former CEO does deserve credit for "having raised awareness for the company, the drug and the disease, by being a passionate and charismatic advocate for all three," Simeonidis said.

Talks with the senior management indicate that the change does not impact expectations of a mid-2015 submission and that "there are no issues with the data."

RBC Capital Markets cited the forthcoming events at Sarepta's:
1. Start enrollment for Study 203 in patients 46yo, 2Q15

2. FDA meeting to discuss data for NDA submission, 2Q15

3. FDA submission of eteplirsen NDA, mid-2015

4. FDA advisory panel, 2H15

5. Full enrollment of Study 301 eteplirsen confirmatory Phase III trial, YE15

6. Complete enrollment for both phases of Study 4053-101 in Europe, YE15

7. FDA decision on eteplirsen based on priority review, 1H16

8. Launch eteplirsen in the US, 1H16

Posted-In: RBC Capital MarketsAnalyst Color Reiteration Analyst Ratings

 

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