Item 8.01. Other Events

On May 1, 2012, Protalix BioTherapeutics, Inc. (the "Company") issued a press release announcing that the United States Food and Drug Administration ("FDA") approved ELELYSO™ (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease. Also on May 1, 2012, the Company issued a second press release announcing that the Company has scheduled a conference call and webcast for Wednesday, May 2 at 8:00 AM EDT to review the FDA's approval of ELELYSO™ and that a second conference call, in Hebrew, is scheduled also on Wednesday at 9:45 AM EDT (4:45 PM IDT). Copies of the press releases are attached hereto as Exhibits 99.1 and 99.2.

Item 9.01. Financial Statements and Exhibits

(d) Exhibits

99.1 Press release dated May 1, 2012.
99.2 Press release dated May 1, 2012.