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PLX – FDA

Feb 12, 2014 07:46 AM Protalix BioTherapeutics (PLX) Updates on PRX-112 Phase I; Plans Presentation
Oct 14, 2013 07:32 AM Protalix BioTherapeutics (PLX) Oral GCD Well-Tolerated in Phase I on Gaucher Disease
Jun 20, 2013 03:10 PM Protalix (PLX) Updates on Three New ProCellEx Compounds
Apr 2, 2013 07:32 AM Protalix Bio (PLX) Treats First Patient in PRX-112 Phase I
Mar 18, 2013 02:17 PM Pfizer (PFE), Protalix (PTX) UPLYSO Receives Approval in Brazil
Feb 13, 2013 07:43 AM Protalix BioTherapeutics (PLX) to Present Data on ELELYSO
Dec 6, 2012 07:49 AM Protalix (PLX) Enters ELELYSO Development Agreement w/ Pfizer (PFE)
Nov 1, 2012 11:04 AM Pfizer (PFE),Protalix (PLX) Report Taliglucerase Alfa Denied Marketing Approval by EC
Sep 27, 2012 06:33 AM Protalix Bio (PLX) Gets Elelyso Marketing Authorization in Israel
Aug 13, 2012 07:33 AM Protalix (PLX) Gets FDA Okay for PRX-102 Phase I/II Study of Fabry Disease
Jul 2, 2012 07:33 AM Protalix BioTherapeutics (PLX) Reports Encouraging Data from Taliglucerase Alfa in Type 1 Gaucher Disease
Jun 25, 2012 07:32 AM Data on Protalix's (PLX) ELELYSO to be Presented at 10th Annual European Working Group on Gaucher Disease Meeting
Jun 22, 2012 08:44 AM Protalix BioTherapeutics (PLX) Hit as EMA CHMP Denies MAA for Taliglucerase Alfa
Jun 22, 2012 08:35 AM Pfizer (PFE), Protalix (PLX) Say Taliglucerase Alfa MAA Not Approved by EMA CHMP
Jun 11, 2012 07:33 AM Protalix (PLX) Gets $25M Milestone from Pfizer in FDA Approval of ELELYSO as Treatment of Type 1 Gaucher
May 1, 2012 06:39 PM Protalix (PLX) Shares Jump Following FDA Approval of ELELYSO, Co. to Host Call at 8am ET Wednesday
May 1, 2012 04:22 PM FDA approves Protalix's (PLX) Gaucher Disease drug Elelyso
May 1, 2012 08:10 AM Traders Eye Protalix BioTherapeutics (PLX) Ahead of FDA PDUFA Date
Apr 30, 2012 10:51 AM UPDATE - Auriga Downgraded Protalix BioTherapeutics (PLX) to Hold; Odds of FDA Approval Are Difficult to Gauge
Apr 19, 2012 09:14 AM Canaccord Genuity Reiterates a 'Buy' on Protalix BioTherapeutics (PLX); U.S. Tali Approval May Unlock Potential
Dec 6, 2011 11:09 AM Protalix (PLX) Shares Hit as FDA Extends Taliglucerase Alfa PDUFA by Three Months
Dec 6, 2011 07:31 AM FDA Extends PDUFA Date for Protalix's (PLX) Taliglucerase Alfa NDA
Nov 10, 2011 07:00 AM Protalix (PLX) Reports Presentation of PRX-105 Research on Striatum Splicing Patterns
Oct 17, 2011 09:51 AM Canaccord Genuity on Life Sciences/Biotechnology: FDA �Flexibility� May Add To Advantages of Orphan Drugs in Today's Market
Sep 8, 2011 10:58 AM Protalix (PLX) Reports Publication of Encouraging Data from Taliglucerase Phase III in Gaucher Disease
Aug 17, 2011 07:50 AM Protalix (PLX) Says FDA Accepts Resubmission of CRL for Taliglucerase Alfa; Sets Feb. 1 as PDUFA Date
Aug 1, 2011 08:04 AM Protalix (PLX) Submits Reply to Taliglucerase Alfa Response Letter from FDA
Feb 25, 2011 06:37 AM Protalix (PLX) Receives FDA CRL On Taliglucerase
Feb 24, 2011 10:37 AM Protalix BioTherapeutics (PLX) Lower Ahead of Tomorrow's PDUFA Date
Feb 14, 2011 02:28 PM Canaccord Adams Sees Protalix BioTherapeutics (PLX) FDA Approval Early
Jan 19, 2011 06:59 AM Protalix (PLX) Updates on PRX-102 and Gaucher Treatment GCD
Nov 2, 2010 08:39 AM Protalix BioTherapeutics (PLX) Completes Patient Switch from Cerezyme to Taliglucerase Alfa in Gaucher Study
Sep 29, 2010 09:17 AM Brazil To Produce Pfizer/Protalix Gaucher Disease Drug In $730 Million Deal
Aug 16, 2010 09:00 AM Protalix (PLX) Discloses $30M Pfizer Taliglucerase Alfa Supply Agreement In Latin American
Jul 12, 2010 08:04 AM Protalix BioTherapeutics (PLX) NDA for Taliglucerase Alfa Accepted for Review by U.S. FDA
Apr 27, 2010 08:36 AM Protalix BioTherapeutics (PLX) Submits Validation Data to FDA on Taliglucerase Alfa Manufacturing
Mar 17, 2010 07:24 AM Protalix BioTherapeutics (PLX) Announces Commencement of PRX-105 Phase I
Feb 2, 2010 07:33 AM Protalix BioThera (PLX) to Supply U.S. FDA with Additional Data Tied to Taliglucerase Alfa NDA
Jan 14, 2010 04:12 PM Protalix (PLX) Gets Orphan Drug Recommendation on Taliglucerase Alfa
Jan 13, 2010 07:38 AM Protalix BioTherapeutics (PLX) Taliglucerase Alfa Gets Recommendation from EMEA (PFE)
Dec 9, 2009 07:33 AM Protalix (PLX) Completes NDA Submission for taliglucerase alfa
Dec 1, 2009 09:11 AM Protalix (PLX) Sells-Off On Pfizer News, As Fast Money Disappointed In No Takeover
Dec 1, 2009 06:41 AM Protalix (PLX) Enters Deal With Pfizer (PFE) To Develop Gaucher's Disease Treatment
Sep 14, 2009 09:27 AM Protalix (PLX) Completes Pivotal Phase III Trial for prGCD for the Treatment of Gaucher Disease
Sep 8, 2009 07:34 AM FDA Grants Protalix (PLX) Orphan Drug Designation for prGCD
Aug 25, 2009 08:07 AM Protalix (PLX) Receives FDA Fast Track Designation for prGCD
Aug 17, 2009 07:32 AM Protalix BioTherapeutics (PLX) Announces FDA Approval of Treatment Protocol for prGCD
Jul 14, 2009 08:15 AM Protalix BioTherapeutics (PLX) Holds Pre-NDA Meeting with FDA for prGCD
Jul 6, 2009 07:50 AM Protalix (PLX) Approached by the FDA to Consider Submitting a Treatment Protocol for the Use of prGCD
Jul 13, 2007 03:27 PM Protalix BioTherapeutics (PLX) Receives Special Protocol Assessment Approval from FDA for its Phase III Clinical Study of prGCD
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