This Upcoming Event Could Affect Sarepta Therapeutics Investors

Credit Suisse commented on Sarepta Therapeutics Inc SRPT ahead of an FDA workshop on Friday titled "Measuring Dystrophin in Dystrophinopathy Patients and Interpreting the Data."

Analysts led by Jeremiah Shepard thought the meeting would "highlight the pros and cons of current methods for quantifying dystrophin and might provide a framework for the anticipated review of SRPT's eteplirsen NDA."

Shepard felt that the panel meeting would be neutral for the stock, however, the analyst expected "that dissenting points of view about dystrophin could weigh on the stock for the short-term."

The analysts thought that dystrophin could be used as a surrogate marker for approving eteplirsen under accelerated approval. "A surrogate endpoint used for accelerated approval is a marker - a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit," according to the FDA definition.

Shepard did not anticipate that the panel discussion would "provide binding guidance on how to review the expected eteplirsen NDA, but the tenor of the discussion and various points of view could influence the FDA's position on dystrophin quantification and its thinking around dystrophin as a surrogate."

Several companies are expected to present at the meeting including PTC Therapeutics, Inc. PTCT which had stated previously that it did not think dystrophin could "serve as a surrogate endpoint due to limitations of quantifying dystrophin."

BioMarin Pharmaceutical Inc. BMRN was also expected to be present and to make an argument against dystrophin as a surrogate at Friday's workshop.

Credit Suisse maintained an Outperform rating on the stock with a $36 price target.

Sarepta Therapeutics recently traded at $13.41, down 1.32 percent.