Sarepta Shares Under Pressure As Jefferies Downgrades To Underperform

Sarepta Therapeutics Inc SRPT shares have gained 30 percent since April 22. Jefferies’ Gena Wang downgraded the rating for the company to Underperform, while maintaining the price target at $7.

Comments by CDER director Janet Woodcock at the AdCom had fueled some speculation on the potential approval of eteplirsen. Dr. Woodcock had noted flexibility and Type 2 error, and expressed sympathy to DMD pts.

Dr. Eric Bastings, deputy director of division of neurology products, stressed that the FDA is a science-based organization, even though there were pressures that it faced. Flexibility should be based on substantial evidence, the FDA's AdCom presentation noted. The current weak biomarker and clinical data does not seem to constitute substantial evidence for accelerated or even standard approval.

Analyst Gena Wang mentioned that the current weak evidence based on the FDA analysis did not support drug effect and there seemed to be low probability of an approval on the PDUFA date of May 26. New controlled Phase III trials may be required for full approval.