Edwards Lifesciences (NYSE:EW) hit a new 52-week high yesterday as Wall Street reacted to news of an FDA panel’s near-unanimous recommendation to expand approval of its Sapien transcatheter heart valve.
Edwards opened yesterday at $91.21, hit the $99 high mid-morning and closed at $96.88, clusing up 7% on the day.
Analysts lined up to raise their valuations on the company in light of the FDA vote, which was 11-0 in favor, with 1 abstaining, for expanding approval for the Sapien transcatheter aortic valve implantation system to a wider group of patients. Should the FDA follow the panel’s recommendation, Edwards will win approval to market its transcatheter aortic valve implant for patients whose aortic stenosis is operable, but who are not good candidates for open heart surgery.
Analysts at Jeffries, Leerink Swann, Citigroup, Barclays, Deutsche Bank and BMO Capital all raised their price targets for the company, some by as much as $21, helping drive the stock’s spike on The Street.
Shares continued to rise after hours, gaining another 1.2% and trading at $98 as of about 6:30 p.m. last night.
EW shares opened up a hair today at $97.42 and were trading at $96.96 as of about 10 a.m.
The device maker in November 2011 won PMA for the Sapien device for inoperable patients with aortic stenosis, a hardening and narrowing of the aortic valve.
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