Baird Positive on Surprise FDA Clarification on Sarepta Therapeutic (SRPT)
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Baird analyst Brian Skorney was out positive on Sarepta Therapeutic (NASDAQ: SRPT) after the FDA responded publicly to clarify on what they've told the company.
Skorney notes, "In what is by far the strangest back and forth we've seen between a sponsor and regulators, the FDA has issued a response to the outcry from the DMD community following Sarepta's press release earlier this week. While the letter reads as a sharp criticism of the company's management of information disclosure, it also provides comfort that the agency's efforts to better understand the profile didn't turn up anything to insinuate data manipulation."
He added, "Following the FDA response, we're beginning to think the whole delay isn't a result of a guidance change but a misunderstanding of the submission/review process and timeline. It seems increasingly like the FDA meant to guide Sarepta to submit the additional requested data during a rolling submission process, prior to NDA completion as opposed to following a standard NDA submission, prior to the completion of the review as Sarepta interpreted it following the April minutes."
The FDA statement can be seen here.
The firm maintained a Neutral rating and $21 price target on the stock.
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 $15.73 yesterday.
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