Protalix BioTherapeutics, Inc. (NYSEMKT:PLX) Files An 8-K Other Events
Item 8.01. Other Events
On May 9, 2017, Protalix BioTherapeutics, Inc. (the Company)
issued a press release announcing that the U.S. Food and Drug
Administration (FDA) cleared an Investigational New Drug
application (IND) for a clinical trial evaluating the safety and
efficacy of administering 2 mg/kg of pegunigalsidase alfa
(PRX-102) once monthly in Fabry patients. The current dosing
regimen for approved enzyme replacement therapies for Fabry
disease is once every two weeks. A copy of the press release is
attached hereto as Exhibit 99.1 and is incorporated by reference
herein.
Item 9.01. Financial Statements and Exhibits
| (d) | Exhibits |
| 99.1 | Press release dated May 9, 2017. |
About Protalix BioTherapeutics, Inc. (NYSEMKT:PLX)
Protalix BioTherapeutics, Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of recombinant therapeutic proteins based on its ProCellEx protein expression system (ProCellEx). The Company has developed taliglucerase alfa (marketed under the name Uplyso in Brazil and certain other Latin American countries and Elelyso in the rest of the territories) for the treatment of Gaucher disease that has been approved for marketing in the United States, Brazil, Israel and other markets. The Company’s product pipeline includes PRX-102 for the treatment of Fabry disease; AIR DNase (PRX-110) for Cystic Fibrosis, and Oral Anti-TNF (OPRX-106) Anti Inflammatory. PRX-102 or alpha-GAL-A is an enzyme replacement therapy product for the treatment of Fabry disease. AIR DNase is a plant cell recombinant human Deoxyribonuclease 1. Oral Anti-TNF represents a mode of administering a recombinant anti-TNF protein. Protalix BioTherapeutics, Inc. (NYSEMKT:PLX) Recent Trading Information
Protalix BioTherapeutics, Inc. (NYSEMKT:PLX) closed its last trading session 00.000 at 0.920 with 606,063 shares trading hands.