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FDA Accepts Protalix Resubmission For Gaucher Disease Drug; Shares Up

DOW JONES NEWSWIRES Protalix BioTherapeutics, Inc. (PLX) said the U.S. Food and Drug Administration has accepted its resubmitted new drug application for its experimental drug for Gaucher's disease, a rare genetic ailment. Protalix shares were up 4.8% at $5.01 in recent premarket trading. The stock through Tuesday's close is down 52% this year. The U.S. regulator in February had requested more data on clinical trials and on chemistry, manufacturing and controls for the experimental treatment, information the company at that time said it didn't have when it first submitted the new drug application. Protalix on Wednesday said the new submission addresses the FDA's questions, including its request for clinical data from the company's switchover trial and long-term extension trial. Gaucher's disease affects one of 20,000 live births and causes a fatty substance to develop in cells in the liver, spleen and bone marrow. Protalix is developing the product with Pfizer Inc. (PFE). The pharmaceutical giant's shares were up 7 cents at $18.38 in recent premarket trading. -By Tess Stynes, Dow Jones Newswires; 212-416-2481;

Stock News for Protalix Biotherapeutics (PLX)
06/19/201308:26:20Protalix Reaches Pact to Transfer Technology for Gaucher Disease...
04/29/201308:40:57Protalix BioTherapeutics Treatment for Gaucher Disease Approved...
12/06/201208:36:34Protalix Signs Deal With Pfizer to Continue Managing Elelyso...
06/22/201209:50:54EMA Recommends Against Marketing Authorization to Pfizer and...
06/11/201208:29:40Protalix Gets $25 Million Milestone Payment For Rare-Disease...
05/02/201216:17:45US Stocks Trade Lower Late On Concerns Over Hiring, Europe
05/02/201214:40:14US Stocks Edge Lower On Weak Private-Sector Hiring
05/01/201217:37:05CORRECT: FDA Approves Protalix, Pfizer Drug To Treat Gaucher...
05/01/201217:07:24FDA Approves Protalix, Pfizer Drug To Treat Gaucher Disease
08/17/201108:57:24FDA Accepts Protalix Resubmission For Gaucher Disease Drug; Shares...
02/25/201107:31:34Protalix: FDA Requests More Information On Gaucher's Drug
10/01/201011:53:15Genzyme Efforts To End Cerezyme Shortage Proceeding
09/15/201013:31:11Genzyme To End Fabrazyme Rationing By Mid-2011
07/12/201007:02:50FDA May Not Rule On Protalix's Gaucher's Treatment Until 2011
02/19/201007:52:16Shire 4Q Profit Up 23% As Drug Sales Offset Generic Losses
12/01/200912:10:05Pfizer-Protalix Deal Strengthens Competition For Genzyme
12/01/200907:25:14Pfizer To Pay Protalix Up To $115 Million In Gaucher's Deal

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