Oppenheimer Downgrades Sarepta Therapeutic (SRPT) to Perform
Oppenheimer downgraded Sarepta Therapeutic (NASDAQ: SRPT) from Outperform to Perform after the FDA hosted an AdCom to discuss SRPT's eteplirsen NDA and the result of 5-voting questions was unambiguously negative.
Analyst Christopher Marai commented, "We'd have viewed even a positive vote on the final question as supportive of approval. The scope of the data-package, lack of placebo control and inability of the panel to recognize an efficacy signal contributed to the outcome in our view. The FDA typically follows the advice of the panel and given outcome we believe chances of approval are increasingly slim, thus we are moving to the sidelines. We note the FDA makes a Type-2 error by not approving a drug that works, and that FDASIA, statutory regulatory flexibility, patient involvement, and unmet need leave the window open for approval. Downgrading to Perform from Outperform and removing our $60 price target."
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Shares of Sarepta Therapeutic closed at $14.95 yesterday.