Showing posts with label Protalix Bio Therapeutics. Show all posts
Showing posts with label Protalix Bio Therapeutics. Show all posts

Wednesday, May 2, 2012

Wednesday’s biggest gaining and declining stocks

Wednesday’s biggest gaining and declining stocksShawshank, VA 5/2/12 (StreetBeat) – Shares of Charming Shoppes (Nasdaq: CHRS +23.39%) rose 24%. The company agreed to be bought by Ascena Retail Group Inc. (Nasdaq: ASNA +10.19%) for $7.93 a share, or about $890 million. Ascena’s shares also rose, up 13%.

Protalix BioTherapeutics (Nasdaq: PLX +15.19%) rallied 14%. The company said the Food and Drug Administration approved one of its treatments for adults with a confirmed diagnosis of type 1 Gaucher disease.

TripAdvisor Inc. (Nasdaq: TRIP +16.75%) jumped 16%. The company reported sharp growth in revenue for the first quarter, both on a year-over-year and a sequential basis.

Decliners

Chesapeake Energy Corp. (NYSE: CHK -12.99%) shares fell 13%. The company said in a regulatory filing that it had ended certain arrangements with CEO Aubrey McClendon. Also on Wednesday, analysts at Robert W. Baird cut their rating on Chesapeake to neutral from outperform.

American Depositary Shares of Banco Santander SA (NYSE: STD -6.50%) shed 6.4%, retreating with the broader Spanish market following recent data showing the country has dipped back into recession amid the European debt crisis.

Shares of OpenTable Inc. (Nasdaq: OPEN -15.98%) retreated 17%. Late Tuesday, the company reported first-quarter results and issued a financial outlook for the second quarter and the full year.

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Tuesday, December 6, 2011

FDA Extends Taliglucerase Alfa PDUFA Date to May 1, 2012

FDA Extends Taliglucerase Alfa PDUFA Date to May 1, 2012Palm Beach, FL 12/6/11 (StreetBeat) --Protalix BioTherapeutics, Inc. (AMEX: PLX), announced today that it received notification from the U.S. Food and Drug Administration (FDA) that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date of the New Drug Application (NDA) 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 (GCD), 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. As this information was requested and provided within 90 days of the February 1, 2012 PDUFA goal date, the agency has the option to extend the PDUFA goal date to provide adequate time for the FDA to complete their review. A three month extension cycle is the standard period granted. No additional data were requested by the FDA in the notification, nor was the Company notified of any specific deficiency in the taliglucerase alfa NDA.

"We believe we have addressed the FDA's request," said Dr. David Aviezer, Protalix's President and Chief Executive Officer. "We look forward to working closely with the agency as it continues its review."

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