Delay News Blndsides Regeneron Shares Print E-mail
By Staff and Wire Reports   
Wednesday, 17 August 2011 06:18
Regeneron Pharmaceuticals (Nasdaq:REGN) declined as much as 13 percent in extended trading after U.S. regulators delayed a decision on whether to approve the company’s treatment for a common cause of blindness. The Food and Drug Administration has pushed back its target date for completing its review of the company's experimental eye drug, Eylea, by three months. 

According to reports, the agency now will look to complete its review of the drug by Nov. 18. The FDA needs more time to review recent responses as part of Regeneron's bid to obtain a license for the drug as a treatment for "wet" age-related macular degeneration, a common cause of blindness.

If Eylea is approved, it would be the first drug to compete with Roche's Lucentis. Eylea is injected every eight weeks, half as often as Lucentis. The less frequent dosing would help Regeneron capture 25 percent of the U.S. market from Lucentis, Edward Tenthoff, a senior research analyst with Piper Jaffray & Co. in New York, said yesterday in a note to investors.

In June, Bayer filed for approval of Eylea as a treatment for wet age-related macular degeneration in Europe and Japan.

Here is a look at other healthcare movers from Tuesday's markets:

Gainers (% price change) Last Trade Change Mkt Cap
Idenix Pharmaceuticals IDIX 4.60 +0.32 (7.48%) 441.58M
Syneron Medical Ltd. ELOS 10.80 +0.65 (6.40%) 375.84M
ISTA Pharmaceuticals, Inc ISTA 5.00 +0.27 (5.71%) 168.16M
ArQule, Inc. ARQL 4.70 +0.25 (5.62%) 250.88M
QLT Inc. (USA) QLTI 6.47 +0.30 (4.86%) 323.18M
Losers (% price change)
MannKind Corporation MNKD 2.59 -0.25 (-8.80%) 339.21M
Cornerstone Therapeutics CRTX 7.65 -0.71 (-8.49%) 198.52M
Array BioPharma Inc. ARRY 2.12 -0.19 (-8.23%) 120.88M
Cytori Therapeutics Inc CYTX 3.69 -0.33 (-8.21%) 193.62M
RadNet Inc. RDNT 2.71 -0.21 (-7.19%) 101.14M
Most Actives (dollar volume)
Johnson & Johnson JNJ 64.36 -0.23 (-0.36%) 176.42B
Pfizer Inc. PFE 18.31 -0.03 (-0.16%) 144.67B
Merck & Co., Inc. MRK 32.10 -0.03 (-0.09%) 99.08B
Gilead Sciences, Inc. GILD 38.85 +1.58 (4.24%) 29.97B
Kinetic Concepts, Inc. KCI 67.84 +1.86 (2.82%) 4.96B




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