With Exondys 51 approved, Sarepta chief Ed Kaye to bow out

Sarepta's new leader will be looking to its pipeline to find a medication to treat more patients.

He was for a long time an interim chief executive, then a full CEO and president, but Ed Kaye, who did what looked impossible a year ago and got Sarepta’s controversial Duchenne medication approved, will now step down later this year.

He’ll still be a director, but the hunt is on for a new CEO: Last night, Bio Twitter was abuzz with M&A rumors, with some speculating his departure will be a forerunner to a deal.

There were already some hints, however, given that he was not planning on many more years, remained an interim CEO for so long, and recently hung up his chief medical officer title, handing that over to former Regeneron executive Catherine Stehman-Breen, M.D., M.S.

As The Street’s Adam Feuerstein said last night: “$SRPT CEO Ed Kaye. Class act. Took over job he didn’t really want and executed extremely well.”

The SEC filing said the resignation “was planned,” although it added that Kaye only informed them of his decision four days ago. His current contract runs until Sept. 20, and he can leave then, “or some other future date.”

FierceBiotech asked Kaye last year, just after Exondys 51 had been approved, what the experience of getting this drug to market had been like. “It’s been challenging, and we along with these families have had our ups and downs and it has not been an easy course," he said.

“That thought [to get the drug on the market] was on my mind constantly; that I had an obligation to get this to the finish line and allow them to use the drug if they wanted. I’d say all in all, it’s been a unique experience and what it shows it just how much a small group of people, who are very dedicated, can do. As Woody Allen once said, 80% of success is showing up; so you’ve just got to hang in there every single day, and remember why you’re doing what you’re doing.”

Sarepta’s current FDA-approved DMD med Exondys 51 (eteplirsen), which got the nod last fall despite having limited data and a negative AdComm, is designed to treat certain patients—namely those with the mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13% of the population with DMD.  The genetic condition usually proves fatal by early adulthood.

A new CEO (or owner) will be looking to its pipeline, and includes research deals with Nationwide Children’s Hospital to work on their microdystrophin gene therapy program, as well as another form of gene therapy.