Needham & Company Confirms Sarepta Therapeutic (SRPT) Pulls From Conference; Likely Due to FDA Meeting

Needham & Company analyst Chad Messer confirmed to StreetInsider.com that Sarepta Therapeutic (NASDAQ: SRPT) did in fact cancel from the Needham Healthcare conference scheduled tomorrow.

The analyst believes this is tied to an FDA meeting to discus the details of a confirmatory study for eteplirsen in Duchenne’s muscular dystrophy (DMD). On their last earnings call in late February Sarepta announced they expected to meet with the FDA in March. Sarepta was scheduled to present and do 1x1s with investors on Tuesday.

The likely news Messer is expecting to come from the FDA meeting:

Confirmatory Study Issues: The biggest outstanding issue with regards to the study is what to do about the control arm. Given the fact that there is evidence for efficacy and the disease is so severe, it would be problematic to give placebo to patients who might benefit. It would also make the study harder to enroll since there are so few patients. Sarepta has suggested to the FDA that they use DMD patients who have a different mutation than the one that eteplirsen fixes. These patients can then be rolled over later into a new study that tests drugs to address their mutation. Sarepta has already begun preclinical work on several new drugs that address different mutations.

Pending Issue of Early Filing: Of course, another topic of high investor interest that could possibly come up with FDA is whether or not Sarepta can file an NDA based on the completed Phase IIb study. Sarepta was previously optimistic that they would be allowed to file based on previous conversations with the FDA. The company then changed its mind and stated that they do not believe they will be allowed to file early after a subsequent FDA meeting in November. The FDA has not made a formal decision one way or another and, in fact, is not required to make a decision unless Sarepta actually files. The company has said they will only file the NDA early if they believe the FDA will be inclined to accept it.

The firm has a Buy rating and price target of $36 on SRPT.

UPDATE: A Sarepta Therapeutics spokesperson also confirmed the cancellation saying, "unfortunately we had to cancel due to other obligations that prevent us from participating."

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 $23.05 yesterday.

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