Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Protalix Says FDA Extends Taliglucerase Alfa PDUFA Date To May 1, 2012

RELATED NEWS
Trade PLX now with 

Protalix BioTherapeutics, Inc. (PLX: Quote) Tuesday said it has received notification from the U.S. Food and Drug Administration that the FDA has extended the Prescription Drug User Fee Act goal date of the New Drug Application for taliglucerase alfa to May 1, 2012, a three-month extension from the previous PDUFA date of February 1, 2012.

Taliglucerase alfa is the Company's proprietary plant cell expressed recombinant form of human Glucocerebrosidase, which is being developed for the treatment of Gaucher disease.

In November 2011, the Company submitted certain clinical information regarding taliglucerase alfa in response to an FDA request. This request related mainly to the presentation of select data provided in the NDA.

Click here to receive FREE breaking news email alerts for Protalix BioTherapeutics Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
After ending the previous session modestly lower, stocks are turning in a lackluster performance in early trading on Thursday. The major averages have turned mixed on the day, with the Dow benefiting from a strong gain by shares of Visa (V). Hundreds of protesters stormed Burkina Faso's parliament on Thursday and set fire to the building, preventing the lawmakers from considering a bill to extend the president's 27-year rule. Security forces opened fire on protesters, as they looted computers and televisions in the National Assembly, news agencies reported. The angry crowd then marched towards the President's office, before they were U.S. economic activity increased by more than expected in the third quarter of 2014, according to a report released by the Commerce Department on Thursday. The Commerce Department said GDP increased by 3.5 percent in the third quarter compared to 3.0 percent growth expected by economists.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.