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

Quick Facts

Editors Pick
Toyota Motor Corp. (TM, TYT.L) Thursday announced 1.1 percent decline in worldwide production for October, as there was a sharp decline in production of passenger cars in Japan. Production outside Japan improved 2.3 percent. In a separate announcement, the Japanese automaker said it will recall more... Computer and printer maker Hewlett-Packard Co. said Tuesday after the markets closed that its fourth quarter profit fell 6% from last year, as revenue declined 2%. The company's quarterly earnings per share, excluding items, came in line with analysts' expectations, but its quarterly revenue fell short of analysts' forecast. This organic and natural products company has experienced strong compounded annual growth over the last four fiscal years with its net sales growing 25% and adjusted income from continuing operations over 30%.
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.