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: “Sarepto 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.
By Ben Adams
Source: Fierce Biotech
Novartis will acquire Mariana’s lead candidate MC-339, a radioligand therapy (RLT) designed to target small-cell lung cancer. Last year, Mariana had raised $175m in a Series B round from several funds and pharma giant Eli Lilly.
The company’s aspiration to expand the use of its obesity products to cardiovascular indications has been successful. In March, its blockbuster drug Wegovy was approved by the US Food and Drug Administration (FDA) for reducing the risk of cardiovascular diseases in obese or overweight adults.
Massachusetts-based Deciphera brings to the table an extensive kinase inhibitor pipeline, kinase drug discovery expertise, and a strong commercial and sales platform in the US and European markets that is meant to advance Ono’s capabilities and presence in the oncology space.
