Sarepta (SRPT) Could Still Gain Approval - Oppenheimer

Oppenheimer analyst, Christopher Marai, believes it is still possible for Sarepta (NASDAQ: SRPT) to gain approval and recommends buying shares going into the panel decision. He believes it is possible to gain approval on the basis that it is safe and offers at least a minor measurable benefit.

SRPT’s post hoc analysis highlights 16.7% loss of ambulation vs. 89.7% for SRPT’s proposed historically matched control. Independent data we reviewed highlights LOA for DMD patients aged 11.0-14.6 has a range of 25-75% (increases with age) and depends on SOC and genotypes (Exhibit 1, p.3). Median LOA in prior studies (Exhibit 2, p.4) was 14.5 years and 12 years with daily and intermittent GC-steroids respectively.

Uncharted territory makes this risky; however several oncology drugs have been approved based on low response rates or modest (months) improvements in overall survival. If LOA data is considered, we believe Friday's panel may find that eteplirsen results in a modest benefit, which together with safety yields a positive risk/benefit finding.

New four-year data will delay the PDUFA decision beyond February 26 as FDA takes more time to evaluate newly submitted data. Unsurprisingly dystrophin as a surrogate is a no-go, though data appears to support MOA in FDA's briefing comments.

The firm maintained an Outperform rating and $45 price target.

For an analyst ratings summary and ratings history on Sarepta Therapeutic click here. For more ratings news on Sarepta Therapeutic click here.

Shares of Sarepta Therapeutic closed at $13.44 yesterday.

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