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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)
05/09/201617:25:40Quarterly Report (10-q)
05/09/201607:17:46Current Report Filing (8-k)
04/22/201617:02:58Amended Annual Report (10-k/a)
04/08/201617:01:54Current Report Filing (8-k)
04/07/201609:13:22Amended Statement of Ownership (sc 13g/a)
04/01/201617:02:05Current Report Filing (8-k)
03/09/201619:46:35Protalix BioTherapeutics Presents Positive Six and Twelve Month...
03/08/201607:38:57Current Report Filing (8-k)
03/03/201607:07:28Current Report Filing (8-k)
02/12/201613:07:16Amended Statement of Ownership (sc 13g/a)
02/11/201614:52:39Amended Statement of Ownership (sc 13g/a)
02/08/201610:43:54Amended Statement of Ownership (sc 13g/a)
01/04/201616:31:56Current Report Filing (8-k)
12/21/201506:01:39Notice of Effectiveness (effect)
12/15/201510:13:07Confidential Treatment Order (ct Order)
12/15/201507:31:59Statement of Changes in Beneficial Ownership (4)
12/11/201516:35:07Amended Quarterly Report (10-q/a)
11/27/201513:16:49Securities Registration Statement (simplified Form) (s-3/a)
11/23/201516:50:30Statement of Ownership (sc 13g)
11/23/201516:07:08Current Report Filing (8-k)

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