2016 Press Releases

2016 Press Releases
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2016 Press Releases

Dec-01-2016

Protalix BioTherapeutics Announces Investor Call

CARMIEL, Israel, Dec. 01, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX) announced today that the Company will hold an investor conference call on December 2, 2016 at 7:00 a.m. (Eastern time), where the Company will discuss the recently priced private exchange (the “Exchange”) and related private placement of secured notes (the “Private Placement”), as well as the progress of its product candidates. If you would like to participate in the call, please dial... 
Dec-01-2016

Protalix BioTherapeutics Announces Private Note Exchanges and Private Placement of Secured Convertible Notes due 2021

CARMIEL, Israel, Dec. 01, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX) (the “Company”) announced today the entry into a definitive exchange agreement relating to an exchange (the “Exchange”) of $54.1 million principal amount of the Company’s outstanding 4.50% Senior Convertible Notes due 2018 (the “Existing Notes”) for (i) $40.2 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2021 (the “Notes”) and (ii) approximately 23.8... 
Nov-30-2016

Protalix BioTherapeutics Enrolls First Patient in Phase II Clinical Trial of OPRX-106 for the Treatment of Ulcerative Colitis

CARMIEL, Israel, Nov. 30, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that the first patient has been enrolled in its phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis.  OPRX-106 is a plant cell-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain (TNFRII-Fc). “With the enrollment of the first patient in our OPRX-106 phase II trial, clinical studies are now underway for our t... 
Nov-22-2016

Alfataliglicerase Approved for Pediatric Indications in Brazil for the Treatment of Gaucher Disease in Children Four years and Older

Approval further supports the advanced ongoing discussions with the Brazilian Ministry of Health for the supply of a significant amount of alfataliglicerase for Gaucher patients in Brazil CARMIEL, Israel, Nov. 22, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX) announced today that the Brazilian National Health Surveillance Agency (ANVISA, Agencia Nacional de Vigilancia Sanitaria) has granted regulatory approval for alfataliglicerase as a long-term enzyme rep... 
Nov-09-2016

Protalix BioTherapeutics Provides Update and Reports 2016 Third Quarter Results

Patient Enrollment Ongoing for Phase III Fabry Clinical Trial with approximately 10 Patients Currently in Evaluation and Screening Stages Enrollment for the Phase II Cystic Fibrosis Clinical Trial in Final Stages with Results Expected around Year-End Phase II Ulcerative Colitis Study Expected to Commence Before Year-End CARMIEL, Israel, Nov. 09, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX) today announced financial results for the fiscal quarter ended... 
Oct-25-2016

Protalix BioTherapeutics Doses First Patient in Global Phase III Clinical Trial of PRX-102 for the Treatment of Fabry Disease

Six Sites Activated Across the United States and Europe with additional patients currently in the screening process for potential inclusion in trial CARMIEL, Israel, Oct. 25, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that the first patient has been dosed in its global phase III clinical trial of PRX-102 for the treatment of Fabry disease.  There are currently six of the leading Fabry centers activated and participating in the trial, wit... 
Sep-07-2016

Protalix BioTherapeutics Announces Presentation of Results from the Phase I/II Clinical Trial of PRX-102 for the Treatment of Fabry Disease at the Society for the Study of Inborn Errors of Metabolism

CARMIEL, Israel, Sept. 07, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today an oral presentation highlighting the results of the phase I/II clinical trial of PRX-102 for the treatment of Fabry disease will be given at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium being held September 6-9, 2016 in Rome, Italy. The oral presentation titled, “A novel treatment for Fabry disease – IV administration of plant de... 
Aug-10-2016

Protalix BioTherapeutics Announces Additional Positive Data from its Phase I/II Clinical Trial for PRX-102 for the Treatment of Fabry Disease

CARMIEL, Israel, Aug. 10, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today additional positive data from its phase I/II clinical trial of PRX-102 for the treatment of Fabry disease.  PRX-102 is a recombinant, plant cell expressed, pegylated, modified version of the human alpha-Galactosidase-A enzyme. “We are pleased to announce additional positive results from our phase I/II Fabry clinical trial,” said Moshe Manor, Protalix’s President and C... 
Aug-08-2016

Protalix BioTherapeutics Reports Second Quarter 2016 Financial Results

Patient Screening Underway for Fabry Phase III Clinical Trial Data from the Cystic Fibrosis Phase II Clinical Trial Expected Around Year-End CARMIEL, Israel, Aug. 08, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), today announced financial results for the fiscal quarter ended June 30, 2016. “We remain focused on developing our clinical assets, and now have three drugs being evaluated in clinical trials,” said Moshe Manor, Protalix’s President and Chief ... 
Jul-07-2016

Protalix BioTherapeutics Announces First Patient Dosed in the AIR DNase™ Phase II Clinical Trial for Cystic Fibrosis

CARMIEL, Israel, July 07, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today the first patient has been dosed in the Company’s phase II clinical trial of AIR DNaseTM (PRX-110) for the treatment of Cystic Fibrosis (CF).  AIR DNase is a plant cell derived recombinant form of human deoxyribonuclease I (DNase I) that the Company has designed, through chemical modification, to be resistant to inhibition by actin.  Given actin is a potent inhibitor of ... 
Jun-06-2016

Protalix BioTherapeutics Initiates PRX-102 Global Phase III Clinical Trial of Fabry Disease to Support United States and European Filings

24-Month Superiority Trial vs. Fabrazyme® for a United States Filing At 12 Months, Interim Analysis of the Superiority Trial Data will be Performed to Test for Non-Inferiority Compared to Fabrazyme for an EMA Filing Additional 12-Month Switch-Over Study from Replagal® to be Initiated to Provide Supportive Data for United States and EMA Filings CARMIEL, Israel, June 06, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that based on guidanc... 
Jun-02-2016

Protalix BioTherapeutics to Present at the Jefferies 2016 Global Healthcare Conference

CARMIEL, Israel, June 02, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), today announced that Moshe Manor, the Company's President and Chief Executive Officer, will present a corporate overview at the Jefferies 2016 Global Healthcare Conference on June 7, 2016 at 9:30 AM ET.  The conference is being held at the Grand Hyatt Hotel in New York City. A live and archived webcast of the presentation will be available at www.protalix.com, on the event calendar p... 
May-09-2016

Protalix BioTherapeutics Reports First Quarter 2016 Financial Results and Provides Corporate Update

Advanced Discussions with FDA regarding SPA for Phase III Clinical Trial of PRX-102  Expected to Commence around Mid-Year Phase II Clinical Trial of PRX-110 in Cystic Fibrosis Patients to commence by Mid-Year Phase II Clinical Trial of PRX-106 in Ulcerative Colitis Patients to commence around Mid-Year Strong Cash Position; finances the Company into 2018, through significant milestones CARMIEL, Israel, May 09, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX... 
Mar-08-2016

Protalix BioTherapeutics Reports Fiscal Year 2015 Financial Results and Provides Corporate Update

Net Income of $58 Million Generated mainly due to the Sale of Our Share in Collaboration to Pfizer Strong Cash Position of $76.3 Million Projected to Fund Operations into 2018 Special Protocol Assessment for Phase III Clinical Trials of Fabry Disease Filed Fabry Disease Phase III Trials Expected to Start in First Half of 2016 Two Proof of Concept Studies in Patients of AIR DNaseTM and Oral antiTNF Planned to Start in Mid 2016 CARMIEL, Israel, March 08, 2016 (GLOBE NEWSWIRE) -- Protalix ... 
Mar-03-2016

Protalix BioTherapeutics Presents Positive Six and Twelve Month Interim Clinical Data on PRX-102 for the Treatment of Fabry Disease at the 12th Annual WORLDSymposium™ 2016

Demonstrated Effectiveness Across All Disease Parameters Including Cardiac and Kidney Functions PRX-102 Safe and Well Tolerated With Very Low Formation of Antibodies CARMIEL, Israel, March 03, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE:PLX) (TASE:PLX), announced today that positive interim data from the Company's phase I/II dose-ranging clinical trial of PRX-102 for the treatment of Fabry disease will be presented on March 3, 2016 at 3:15 PM PT at the Lysosomal Disease Net... 
Feb-22-2016

Protalix BioTherapeutics to Participate in the SunTrust Robinson Humphrey Orphan Drug Day and the 12th Annual WORLDSymposium™ 2016

CARMIEL, Israel, Feb. 22, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE:PLX) and (TASE:PLX), announced today that the Company will participate in the SunTrust Robinson Humphrey Orphan Drug Day and the 12th Annual WORLDSymposiumTM 2016.  The details are as follows: SunTrust Robison Humphrey Orphan Drug Day February 23, 2016 JW Marriott Essex House, New York City, NY 12th Annual WORLDSymposiumTM 2016 February 29 – March 4, 2016 Manchester Grand Hyatt, San Diego, C...