Shares of Edwards Lifesciences (NYSE:EW) bounced back today after losing nearly 5 percent yesterday on speculation that FDA approval of its next-generation Sapien heart valve could be delayed.
Edwards shares closed at $68.53 yesterday, down 4.8 percent from its $72 close the day before. EW shares were trading at $69.73 as of about 1:15 today, up nearly 1.8 percent.
The sell-off started after Wells Fargo analyst Larry Biegelsen reported that a member of the FDA advisory panel that recommended approval of Sapien said the device wouldn’t get a green light until April 2012, according to MoneyWatch. Edwards denied the rumor, saying it’s still banking on approval later this month.
Dr. Jeffrey Borer, the advisory panel member, made the remark at a Chicago medical meeting.
“We believe Dr. Borer was just speculating and we remain confident that Sapien will be approved shortly,” Biegelsen hedged, but that didn’t deter Wall Street investors from selling their EW stakes.
Sapien could drive sales of $210 million next year, Biegelsen predicted; a six-month delay would cut that to about $110 million.
Edwards has had a rough ride of it lately, especially for a company that’s about two years ahead of its nearest competitor for the U.S. transcatheter aortic valve replacement market. Some analysts lowered their estimates for the stock after the Centers for Medicare & Medicaid Services initiated a review of its coverage policy for the Sapien device.