Sarepta Announces CEO Departure But Remains On Track For DMD Drug Approval

Sarepta Therapeutics (SRPT) announced Tuesday night that CEO Christopher Garbedian has resigned from the company and the Chief Medical Officer Ed Kaye will take over as interim CEO until a new one can be found to replace him. Shares of Sarepta are up about 6% on this news of the CEO resignation. There is a possibility that the board of directors may have let Chris Garbedian go in order to improve relations with the FDA. This is because Chris was known to be very vocal and had created strained relations with the FDA. The new CEO even states that Sarepta Therapeutics must improve the relationship with the FDA to get this DMD drug through approval.The new interim CEO Ed Kaye states in the press release:

"I look forward to further strengthening our relationship with the FDA and other regulatory agencies that share our goal of doing what’s in the best interest of DMD patients and their families"

The Board of Directors for Sarepta probably felt that Chris Garbedian was straining the relationship with the FDA to get Eteplirsen approved. Now Ed Kaye states that he will have a nice open dialogue with the FDA to get Eteplirsen approved for patients who desperately need this treatment. DMD stands for Duchenne Muscular Dystrophy. DMD is an inherited rare disorder that involves muscle deterioration which gets quickly worse as the patient gets older. DMD just doesn't affect the muscles in the legs and arms, it eventually targets the patient's heart and respiratory muscles. Muscle weakness is seen at age 3 and then gets progressively worse till possible patient death by the mid 30's. 

There are limited treatment options currently that attempt to restore the proteins of the DMD disease by diminishing the mutation that occurs. This new DMD treatment from Sarepta looks to be just the drug that these patients need. According to the most recent clinical results, Sarepta patients who took Eteplirsen saw a slight decline in the 6-MWT -- 6 minute walk Test -- at week 168 compared to week 144. Despite this, these patients are typically immobilized so the fact that these patients were able to walk a certain distance is improvement in itself. The main primary endpoint for the FDA is whether or not Eteplirsen improves Dystrophin levels in the body. Dystrophin is a protein connected to muscle for movement, therefore an improvement in dystrophin correlates with an improvement in the patient's muscles. The company met the primary endpoint of dystrophin which was measured using a muscle biopsy at week 48. Sarepta now remains on track to file the Eteplirsen NDA-- New Drug Approval --  to the FDA by mid 2015.