Edwards' stock starts rebounding after FDA expanded approval for Sapien valve

Edwards' Sapien transcatheter heart valve--Courtesy of Edwards Lifesciences

Edwards Lifesciences ($EW) has seen its stock climb steadily this week in the wake of an FDA approval to use its Sapien transcatheter heart valve in an even broader class of patients. If the trend continues, those gains could give the company some breathing room in the face of investor revolt over scaled-back sales projections.

Edwards' stock hit $73.08 during late-morning trading on Oct. 4. That's up nearly 1.3% from the day before, and a substantial improvement over a low of $68.25 on Sept. 25.

Still, Edwards is trading much lower than the high of nearly $85 it reached in April, when the company slashed its full-year sales projections by approximately 5% to reflect a slower-than-expected sales start to the year. Investors responded by knocking the share price down over 20%. It has recovered somewhat since, but it dipped again in late September in the wake of news that some investors were suing Edwards, alleging that executives lied about heart valve sales and mislead stockholders about demand for Sapien.

Around that time, Edwards won expanded approval to use Sapien in patients with inoperable aortic valve stenosis. Previously, the FDA's approval covered only transfemoral or transapical delivery of the device, but the new label also removes those restrictions.

The hope is that the latest expansion will boost sales. In the wake of the FDA's news, The Street reported that traders expected Edwards to rebound based on the expanded indication and higher trading volume that followed. So far, those predictions appear to be holding.

- read The Street's story

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