Protalix BioTherapeutics Inc. (PLX)

equity holder wrote:

Chambers von Gekkowire schreibt einige PLX-Artikel.

Die Aktie war mal extrem hoch. Nur wenn andere Medikamente in der Pipeline sind, sehe ich evtl. ein Milliardenunternehm darin. Interessant die Firma.

siehst du den Fall im Jahr 2007? das war der Zeitpunkt als sich der damahlige PLX und TEVA Chef von Protalix verabschiedet hat. Ich glaub der hat sich einfach eine Menge Zeit freigekauft in dem er ging. PLX steht erst heute der FDA gegenüber.

sharewatch wrote:

Video zum Thema Gaucher Disease

http://www.itvisus.com/programs/hbhm/index.asp#ooid=9nZXJxOs6dkG-QA6VpRthRkU18qi3dBH,szZGZiMTrosYZ0HNKZx-l5tSR5eqhQHK

super video sharewatch, thanks :!:

Analyst commentary on Protalix's upcoming FDA decision

Quote:

Written by Patrick Crutcher

Monday, 14 February 2011 12:42

Certainly Protalix BioTherapeutics (AMEX: PLX) is on‎ everyone’s radar with a FDA decision coming on February 25th. We wanted to highlight a recent analyst's note on their upcoming decision.

As we have said before, their data is clean and very comparable to Cerezyme’s available data; their BLA for UPLYSO will very likely receive FDA approval. Additionally, they are awaiting approval in Israel, the EU, and Brazil, with additional filings to come for other territories. We have attached a link to their recent January corporate presentation that overviews the data. In that presentation, they also gave more details on the potential for a long-term supply agreement with the Brazilian government.

More recently, they have been at the center of an analyst tug of war. First, UBS downgrades them to neutral with a $10 price target, then the next day Cannacord Genuity reiterates their buy rating with a $14 price target. We think UBS’s analyst missed the boat here with his comments regarding the labeling. Nothing in the safety data we have seen would suggest the kind of black-box label they are suggesting. Actually, they report only 6% IgC antibodies detected, versus 15% with Cerezyme and 10% with Vpriv. Their 6% hypersensitivity is quite comparable to the labeled 6.8% for Cerezyme.

Cannacord’s Ritu Baral had this to say, “We think PLX/partner Pfizer’s (NYSE: PFE) taliglucerase (tali) for Gaucher’s will get FDA approval on its Feb. 25 PDUFA date. Q1/11 pivotal extension and full switch study data may be key catalysts. We expect a strong US launch in Q2/11 driven by EAP patients and Phase 3b data. We think tali will capture ~15%+ of the $1.2B+ Gaucher’s market, taking Cerezyme market share through strong marketing. We think tali’s safety profile continues to be positive and do not expect black box or special safety language on approval. We continue to believe taliglucerase hypersensitivity rates in clinical trials remain around 6% and that rates of true severe anaphylactoid reactions are much lower. We think safety on the approved label will read very similar to Cerezyme and Vpriv.“

Keep in mind that Protalix will be presenting data from the switchover trial of UPLYSO (taliglucerase alfa) in patients with Gaucher disease and preclinical data on the oral enzyme glucocerebrosidase(GCD) at the 7th Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2011 being held on February 16-18, 2011. Many are very interested in their developments on an oral GCD for Gauchers, since current patients must receive treatment intravenously. They recently spoke very positively about this program at a recent company sponsored medical meeting. The switchover trial data will be important for encouraging doctors and patients to switch to UPLYSO. The huge economic advantage that UPLYSO offers over Cerezyme will be an important factor in sales, especially with healthcare costs on everyone's mind.

More importantly, approval of UPLYSO would validate their plant-cell based technology, becoming the first FDA approved BLA for recombinant therapeutic proteins using a plant-cell based expression system. This technology(ProCellEx) allows for the expression of recombinant proteins that are cost-effective, easily scalable and lack the manufacturing pitfalls of current mammalian-cell based platforms. Their foray into biodefense applications (PRX-105), PRX-102 (Fabry) and rheumatoid arthritis(PRX-106, biosimilar to Enbrel), all become much more interesting programs with an approval under their belt. Approval of UPLYSO would be validation of their technology and make their platform extremely attractive for developing biologic drugs at a fraction of the cost.

Disclosure: Long PLX

Recent coverage - http://biomedreports.com/2011020163067/analysis-of-an-upcoming-fda-decis...

Recent corporate presentation - http://bit.ly/dVY2KI

Protalix Announces Oral Presentations at the WORLD Lysosomal Disease Network Symposium- http://bit.ly/g82dRW

http://biomedreports.com/2011021463717/analyst-commentary-on-protalixs-u...

es gibt gerüchte das die FDA schon morgen PLX zulassen könnte. würde sinn machen aber keine garantie darauf...

aktuell sind 10% der aktien short.

Quote:

PLX-BRIEFING

Canaccord Genuity notes that the PDUFA for Protalix's taliglucerase is largely expected for February 25. However, Firm, says the PDUFA may be issued on February 15, just prior to the WORLD Lysosomal Disease Network conference in Las Vegas. Firm notes that Protalix and partner Pfizer's (PFE) taliglucerase is for treatment of Gaucher's disease.

http://www.happycountdown.com/plx%2Disrael/

lol

sharewatch wrote:

Ich bin dabei @ 9.55

cool. ich auch. :roll: gratuliere zu deinem 1000 Beitrag sharewatch. lol

http://www.happycountdown.com/plx%2Disrael/

nöö ist nur ein coutdown. glück werden wir keins brauchen.

http://www.happycountdown.com/plx%2Disrael/

hilft wohl alles nix, müssen warten bis heute in 1 woche.

die gerüchte das der Entscheid zusammen mit dem Symposium kommen haben sich bis jetzt nicht bestätigt.

PLX handelt heute mit überdurchschnittlichem Volumen.

http://www.happycountdown.com/plx%2Disrael/

# Vol / Avg. 568,179.00/401,182.00

PS: neue Homepage ist online:

http://www.protalix.com/index.asp

sharewatch wrote:

Habe heute PLX nachgeladen @ 9.44. :?

wird schon schieffgehn...

ich find die neue Homepage voll geilo, und den starken Partner erst...Am Freitag ist es dann soweit und die FDA dürfte Ihren Entscheid bekannt geben. Laut Homepage ist der Termin fix. Ich glaube, dass wir hier eine Zulassung sehen werden, was Protalix neue Möglichkeiten eröffnen wird ihr System weiter voranzubringen und weitere Medis auf der gleichen pflanzlichen Protein Basis herzustellen. Konservative 11.50$ könnte es geben. Shortposi ist bei 10%.

http://www.protalix.com/index.asp

http://www.gaucherpartners.com/

kennst du den Film schon, "Love and other Drugs"? muss du dir mal ansehen falls nicht. 8)

Jahresbericht für Protalix kam gestern noch in den AH. Bin noch am lesen, werd später etwas dazu schreiben. Bis jetzt gefällt mir sehr gut was ich gelesen habe. :):)

http://www.sec.gov/Archives/edgar/data/1006281/000095012311017213/y04571...

PLX 9.00$

Wer noch nicht drin ist und will kann sich hier günstige Aktien kaufen. Ich halte meine position bei 9.50$.

Bear Raid ahoi.

Quote:

Inching Closer Towards Approval

by M.E. Garza

Thursday, 24 February 2011

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We are issusing a trade alert this morning, based on a 10K that was filed last night after hours by Protalix BioTherapeutics (AMEX: PLX).

Within the filing, investors will find the answer to the number one open concern going into this week's pending FDA approval PLX/partner Pfizer’s Gaucher's disease enzyme replacement therapy Uplyso (taliglucerase alfa). The agency has set a PDUFA date of 25 February 2011 for the plant-cell expressed therapy.

From the 10-K filing: "On February 20, 2011, we received a letter from the FDA notifying us that the FDA had completed its review of the Establishment Inspection Report in connection with the FDA's inspection of our facility in Carmiel, Israel, and that the FDA had classified our facility as acceptable."

As biotech investors know, the acceptance of a firm's manufacturing facilities are a critical step towards FDA approval. The fact that U.S. regulators have signed off on the Israeli facility bodes well.

Analysts actively covering the sector have been very bullish about the drug candidate's chances in the days and weeks leading up to this point.

Cannacord Genuity’s Ritu Baral had this to say in her latest report: “We think PLX/partner Pfizer’s taliglucerase (tali) for Gaucher’s will be approved by its Feb. 25 PDUFA date. We expect a strong US launch in Q2/11 driven by EAP patients and Phase 3b data. We think tali will capture ~15+% of the $1.2B+ Gaucher’s market, taking Cerezyme market share through strong marketing and competitive pricing. Our $13 target is based on a pNPV analysis."

Ritu's complete report can be dowloaded here.

In addition, Wells Fargo Market Securities issued this comment along with a $12-$14 "outperform" price target for the company:

We believe regulatory approval of Protalix’s lead drug taliglucerase, an enzyme replacement therapy for Gaucher disease partnered with Pfizer (PFE) is highly likely, potentially catalyzing upside for the shares in H1 2011. We also believe Protalix has a unique profile among small-cap biotechs, which should command a

premium: the potential for sustainable profitability from product sales near term, and an underlying technology platform capable of producing other successful candidates longer term. Although recent share appreciation indicates that the company is no longer below investors’ radars, we believe the stock remains undervalued based on the potential of taliglucerase and the unique protein production platform."

The complete report from Wells Fargo Securities can be downloaded here.

As you can see from the chart below, the stock has been trading within a rising channel since April.

That makes this trade candidate appealing as well.

As always, we urge you to do your own due dilligence and to set your stop-losses carefully before any trade.

bin jetzt +-500 im minus. *log off*

huere maipulation. all diese ratingagenturen sind so was von short.

Drama hier.

3 in der Runde?

POZN, AVNR, PLX

http://www.happycountdown.com/plx-israel

wenn ich nicht schon drin wär würd ich jetzt kaufen.