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This Quarter's Sentiment:
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SocialPicks Community
rated strong buy
PLX
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+42.53%
in
76 days
Yesterday, Protalix BioTherapeutics, Inc. ( PLX - Snapshot Report ) announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to prGCD for the treatment of Gaucher disease, an enzyme disorder that can cause liver and neurological problems
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FDA Calendar Updates: Genzyme FDA Woes Benefit Protalix, Shire
PLX
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+49.64%
in
119 days
Below is a summary of updates to the BioMedReports.com FDA Calendar , which includes a database of 293 entries as of 7/31/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results. ...
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FDA Calendar: 2H09 Binary Event Trades
PLX
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+10.57%
in
5 days
(closed on 07/31/09)
<> Below is a selection of companies included in the BioMedReports.com FDA Calendar database of 281 entries as of 7/26/09 with expected binary event catalysts through year-end. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the >...
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BioMedReports: FDA Calendar Updates
PLX
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+27.82%
in
20 days
(closed on 07/26/09)
<> <font> Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 240 entries as of 7/6/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results>...
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Bullish on PLX ...
PLX
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+414.22%
in
240 days
Protalix BioTherapeutics, Inc., a biopharmaceutical company, engages in the development and commercialization of recombinant therapeutic proteins based on its proprietary ProCellEx protein expression system in the United States. Its principal product candidate, prGCD, is a proprietary plant cell expressed recombinant Glucocerebrosidase enzyme for the treatment of Gaucher disease, which has approval to commence phase III clinical trial. The company also develops PRX-102, a proprietary alpha Galactosidase enzyme for the treatment of Fabry disease, a genetic lysosomal storage disorder in human...
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From the Blogosphere
Shire Drug Seeks EU Nod – Analyst Blog
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Shire plc (SHPGY) continues to make progress with its Gaucher disease candidate, velaglucerase alfa. The company recently submitted a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for velaglucerase alfa for the treatment of type I Gaucher disease. The company has already asked for approval in other markets like the U.S. and Canada. Shire is seeking an accelerated review of the MAA. Given the shortage in supply of Genzyme’s (GENZ) Cerezyme, which is the leader in the treatment of patients with Gaucher disease, the Committee for Medicinal Products for Hu...
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Zacks Bull and Bear of the Day Highlights: Sealed Air Corporation, Hologic, Inc., Genzyme Corp., Shire plc and Protalix BioTherapeutics Inc. – Press Releases
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For Immediate Release Chicago, IL – November 17, 2009 – Zacks Equity Research highlights Sealed Air Corporation (SEE) as the Bull of the Day and Hologic, Inc. (HOLX) the Bear of the Day. In addition, Zacks Equity Research provides analysis on Genzyme Corp.(GENZ), Shire plc (SHPGY) and Protalix BioTherapeutics Inc. (PLX). Full analysis of all these stocks is available at http://at.zacks.com/?id=5506 Here is a synopsis of all five stocks: Bull of the Day: <>Sealed Air Corporation (SEE) reported third quarter 2009 EPS of 38 cents, above the Zacks Consensus Estimate of 33 cents and the prior-year >...
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Contamination Issues Haunt GENZ – Analyst Blog
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Biotech company Genzyme Corp. (GENZ), faced yet another setback recently when the U.S. Food and Drug Administration (FDA) announced that vials of five drugs marketed by the company were found to be contaminated. The affected drugs include Cerezyme, Myozyme, Fabrazyme, Aldurazyme and Thyrogen. All these drugs, excluding Thyrogen, are indicated for the treatment of rare disorders. The vials were found to be contaminated with stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process which could potentially harm patients. As adve...
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Why Would an Insider Be Selling Protalix Shares Now of All Times?
Among the shares in Israeli companies in my portfolio tracked by "Globes", Protalix Biotherapeutics Inc. (AMEX:PLX) can be expected to attract the most attention over the coming weeks. It is a rare situation in our area - a biotech company that grew from an Office of the Chief Scientist incubator to reach a market cap of $500 million, on the verge of completing a clinical trial for a drug aimed at a market of over $1 billion in annual sales. <>In the next few days, the last patient will complete the administration of the Gaucher disease drug, and the company said that in October it will repor>...
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Why I'm Buying Protalix
<>I'm adding Protalix Biotherapeutics Inc. (AMEX:PLX) to my portfolio at the expense of half my holding in Fundtech (Nasdaq: FNDT), although I continue to believe in Fundtech as a special niche company in financial software. I'm getting into biotechnology again, which, as is well known, is a risky field but one with dreams of big profits that sometimes come true. My first experience with biotech in my portfolio, with Pharmos Corp. (Nasdaq: PARSD), ended, as will be recalled, with an almost complete write-off after failure in the decisive trial for a new drug. The second, with Omrix, ended wit>...
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