aktien-community.com

[rogueT]

[rogueT]

[carpediem]

@rogueT
Ist ja ein spannendes Teil! Congrats to your deal! Da köchelt "mein" Zock auf kleinerer Flamme. Doch ein Forum dient ja schliesslich auch dazu, auf Dinge aufmerksam zu werden, die man aus welchen Gründen auch immer, selbst nicht entdeckt hat. Danke!

[rogueT]

CEMP mal eben kurz angeschaut, resp. quergelesen was die Broker so meinen. Fazit: volatil seitwärts ist erstmal der wahrscheinlichste Kursverlauf von hier an.

Der FDA CRL beeinhaltet leider nicht nur Defizite rund um den Herstellungsprozess (das kann idR. einfach behoben werden, "meine" OCUL hatte dieses Problem auch, was mich nicht am Kauf hinderte), sondern eine Vergiftung der Leber scheint ein möglicher, starker Nebeneffekt zu sein.
Allerdings ist der FDA die Datengrundlage mit rund 900 Patienten auch zu dünn und sie schlagen vor, nochmal eine Runde mit über 9'000 Patienten zu machen. Falls CEMP dies tut, dann ist das Cash, welches aktuell den Valuecase ausmacht, relativ schnell weg.
Wahrscheinlich wärs das beste, CEMP würde Solithromycin einstampfen, das Verhältnis Entwicklungskosten vs. Marktpotenzial scheint mir auf den ersten Blick wenig erbaulich. Vom anderen Antibiotikum, Taksta werden im Q1 17 Daten erwartet. Das könnte dann wieder für Bewegung sorgen.

Ich behalt den mal im Auge aber rein ziehts mich - noch - nicht. Auch deshalb, weil ich punkto Biotech gerade wieder gut exponiert bin.
Gehe nun mit SGYP, MRUS und PLX ins neue Jahr (LABD bin ich flat wieder raus, der Zeitpunkt ist wohl noch nicht reif dafür).

Good Trades
& en guetä Rutsch allersiits!

[carpediem]

[rogueT]

soso, dann hast du also trotzdem nur den "Bounceback" gespielt und nicht die "Value".
Ist vielleicht auch besser, CEMP konnte seine intraday Gewinne jedenfalls erstmal nicht halten.

Und heute kriegst du gleich die nächste Gelegenheit, denn ITEK wird sich auch mal locker halbieren in der US Handelssession - reinfassen nur auf eigene Gefahr!

[carpediem]

Ja, so ist es.
Aber von ITEK lass ich die Finger, ausser sie gehen mehr als 2/3 runter und auch dann... Die haben jetzt rein gar nichts mehr, wenn ich das richtig gelesen habe. Ich muss ja auch nicht jeden Sch... zocken, denn man liegt schneller flach als man glaubt.

[rogueT]

"meine" PLX meldet heute noch gute Zwischenresultate zu ihrem CF Medi aus der Phase II.
Das war natürlich nicht der Grund meines Einstieges, auf solche binäre Geschichten wette ich bekanntlich nicht, aber die News ist natürlich herzlich willkommen und kann den Anstieg noch weiter tragen.


CARMIEL, Israel, Jan. 03, 2017 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today positive interim results from the Company’s phase II clinical trial of alidornase alfa for the treatment of Cystic Fibrosis (CF) for the first 13 CF patients enrolled in the study. Fifteen patients have been enrolled in, and are expected to complete, the study. alidornase alfa is a plant cell expressed, chemically modified recombinant DNase enzyme resistant to inhibition by actin, which the Company has specifically designed to enhance the enzyme’s efficacy in CF patients.


The phase II trial is a 28-day switch-over study to evaluate the safety and efficacy of alidornase alfa in CF patients previously treated with Pulmozyme®. Participation in the trial is preceded by a two-week washout period from Pulmozyme® before treatment with alidornase alfa via inhalation.

The initial primary efficacy result shows that alidornase alfa improves lung function as demonstrated by a mean absolute increase in the percent predicted forced expiratory volume in one second (ppFEV1) of 4.1 points from baseline. A commercially available small molecule CFTR modulator for the treatment of CF has reported a mean absolute increase in ppFEV1 of 2.5 from baseline in its registration clinical study. This score was achieved while 74% of the patients participating in the trial of the CFTR modulator were also treated with Pulmozyme® on top of the modulator. While this marketed CFTR addresses a certain mutation applicable to less than 50% of CF patients, alidornase alfa is being developed to treat all CF patients.

Sputa available DNA samples were analyzed for approximately half of the patients. A mean reduction of approximately 60% in DNA content from baseline was observed, and a mean reduction of approximately 90% from baseline was observed for sputa visco-elasticity. This data provides further supportive evidence of improved lung function after treatment with alidornase alfa, as demonstrated by the increase in ppFEV1.

No serious adverse events were reported, and all adverse events that occurred during the study were mild and transient in nature.

“We are enthusiastic about the data generated in this trial as we were able to see meaningful improvements in efficacy in a way that have not been reported for a long time in the challenging CF space,” commented Moshe Manor, Protalix’s President and Chief Executive Officer. “We are looking forward to reporting full results from the study before the end of the first quarter of 2017.”

“The preliminary efficacy results of alidornase alfa are very encouraging, even when compared to past trials of approved drugs for the treatment of CF. Although the study was performed on a small number of patients, the data is very encouraging since it shows clinically meaningful results,” said Professor Eitan Kerem, Chairman of Pediatrics, Head of The Cystic Fibrosis Center, Hadassah University Hospital. “I look forward to following the results of upcoming trials of alidornase alfa. If the data continues to be as positive, clearly alidornase alfa will be a key treatment for all CF patients.”

About Protalix BioTherapeutics, Inc.

Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix’s unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights. Protalix’s development pipeline includes the following product candidates: PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; PRX-106, an orally delivered anti-inflammatory treatment; PRX-110, a chemically modified DNase I for the treatment of Cystic Fibrosis; and others.

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms “anticipate,” “believe,” “estimate,” “expect,” “plan” and “intend” and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause material differences include, among others: failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to monitor patients adequately during or after treatment; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and lack of sufficient funding to finance clinical trials; the risk that the results of the clinical trials of our product candidates will not support our claims of safety or efficacy, that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks related to the amount and sufficiency of our cash and cash equivalents; risks related to the successful conclusion of our negotiations with the Brazilian Ministry of Health regarding the purchase of alfataliglicerase, and our commercialization efforts for alfataliglicerase in Brazil generally; risks relating to our ability to make scheduled payments of the principal of, to pay interest on or to refinance our 2018 convertible notes or any other indebtedness; risks relating to the compliance by Fundação Oswaldo Cruz with its purchase obligations and related milestones under our supply and technology transfer agreement; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; delays in our preparation and filing of applications for regulatory approval; delays in the approval or potential rejection of any applications we file with the FDA or other health regulatory authorities, and other risks relating to the review process; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.
Investor Contact

Marcy Nanus
The Trout Group, LLC
646-378-2952
mnanus@troutgroup.com

[carpediem]

Wieder einmal "sell on good news" oder sind die Daten etwa nicht so gut? Also reizen würde es mich jetzt schon, die "Bude" ist ja bei 0.40$ noch mit 50 Mio$ bewertet. Ich kauf mir mal eine (erste) Tranche...

[rogueT]

Ja, wollte ich auch grad schreiben. Muss Sell on good news sein, von einem Equity Offering hab ich jedenfalls nix gelesen.
Dieses kommt ja oft gleich auf gute Nachrichten und einem Kurssprung, aber PLX hat eigentlich noch ordentlich Cash und müsste also eher nicht neue Aktien auf den Markt werfen. Aber man weiss ja nie.
Auf jeden Fall hatte ich auch schon grösseren Schrott im Depot als die hier