Oramed Pharmaceuticals Inc.
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Auszug aus 9-Monats-Bericht:
We initiated a Phase IIb clinical trial on approximately 180 type 2 diabetic patients in approximately 30 sites in the United States, beginning in June 2015. This double-blind, randomized, 28-day study clinical trial is conducted under an Investigational New Drug application, or IND, with the U.S.
Food and Drug Administration, or FDA. The clinical trial is designed to assess the safety and efficacy of ORMD-0801, will investigate ORMD-0801 over a longer treatment period and will have statistical power to give us greater insight into the drugs efficacy. We anticipate that the last patient will complete this
trial during the first quarter of calendar year 2016.
We are also conducting a glucose clamp study of our oral insulin capsule on type 2 diabetic volunteers that will be performed at The University of
Texas Health Science Center at San Antonio and University Health Systems Texas Diabetes Institute. The glucose clamp is a method for quantifying insulin
absorption in order to measure a patients insulin sensitivity and how well a patient metabolizes glucose. As previously announced, the first patient has been
enrolled and we anticipate completing the study in the second quarter of calendar year 2016.
In September 2013, we submitted a pre-IND, package to the FDA, for ORMD-0901, our oral exenatide capsule, for a Phase 2 clinical trial on healthy
volunteers and type 2 diabetic patients. We began pre-clinical studies in November 2014 and expect to begin IND-enabling studies in the second quarter of
calendar year 2016. We then intend to file an IND and move immediately and directly into a large Phase II multi-center trial in the United States. In August
2015, we began a non-FDA approved clinical trial on type 2 diabetic patients, and we anticipate it will be completed during the first quarter of calendar year
2016.
http://www.businesswire.com/news/home/...cs-Market-Analysis-2015-2020
Dazu
http://www.researchandmarkets.com/research/pm25h9/antidiabetics
Interessant für Analyse
http://de.investing.com/equities/oramed-pharmaceuticals-inc-technical
à bientôt
OC
Vermutlich
supp 6.60 6 §
supp 6.17 4 §
supp 5.46 6 §
supp 5.02 2
§
Könnte ORMP unter 6 $ gehen.....nur vermutlich
à bientôt
OC
https://clinicaltrials.gov/archive/NCT02496000/2016_02_01/changes
Rekrutierung abgeschlossen. Folgt bald Meldung: Last Patient out.
http://secfilings.nasdaq.com/...A&RcvdDate=2%2F16%2F2016&pdf=erhöht Aktienanteile um fast 1 Million Aktien: von 896.400 auf 1.880.138 Aktien
Steckt dahinter die Verhandlung mit dem neuen Partner, der bei positiven Ergebnissen der Phase 2b bekannt gegeben wird?
http://services.corporate-ir.net/SEC/...5cGU9MiZmbj0xMDc1MzM5OC5wZGY=
Next up is Oramed Pharmaceuticals Inc. (ORMP:NASDAQ), "which is developing an orally bioavailable form of insulin, as well as an orally bioavailable form of exenatide, which is a member of the GLP-1 agonist subclass.
"Oramed recently inked a China licensing deal with total milestones of $50M." Selvaraju explained. "It is well capitalized for at least the next two years. It will report data from a Phase 2b trial from its oral insulin product, ORMD-0801, in April or May of this year. If those data are positive, and given this is an orally bioavailable form of insulin and is risk mitigated, it should be a transformative event for the company. Positive data could spark acquisition interest from any number of large diabetes players, including the usual suspects, Sanofi SA (SNY:NYSE), Novo Nordisk (NVO:NYSE) and AstraZeneca Plc (AZN:NYSE).
https://www.thelifesciencesreport.com/pub/na/16879
http://services.corporate-ir.net/SEC/...STUlOQ18xMFFfMjAxNjAxMTMucGRmRecent business developments
Seite 20:
Product Candidates
We initiated a Phase IIb clinical trial on approximately 180 type 2 diabetic patients in approximately 30 sites in the United States, beginning in June 2015. This double-blind, randomized, 28-day study clinical trial is conducted under an Investigational New Drug application, or IND, with the U.S. Food and Drug Administration, or FDA. The clinical trial is designed to assess the safety and efficacy of ORMD-0801, will investigate ORMD-0801 over a longer treatment period and will have statistical power to give us greater insight into the drugs efficacy. We anticipate that the last patient will complete this trial during the first quarter of calendar year 2016.
We are also conducting a glucose clamp study of our oral insulin capsule on type 2 diabetic volunteers that will be performed at The University of Texas Health Science Center at San Antonio and University Health Systems Texas Diabetes Institute. The glucose clamp is a method for quantifying insulin absorption in order to measure a patients insulin sensitivity and how well a patient metabolizes glucose. As previously announced, the first patient has been enrolled and we anticipate completing the study in the second quarter of calendar year 2016.
In September 2013, we submitted a pre-IND, package to the FDA, for ORMD-0901, our oral exenatide capsule, for a Phase 2 clinical trial on healthy volunteers and type 2 diabetic patients. We began pre-clinical studies in November 2014 and expect to begin IND-enabling studies in the second quarter of calendar year 2016. We then intend to file an IND and move immediately and directly into a large Phase II multi-center trial in the United States. In August 2015, we began a non-FDA approved clinical trial on type 2 diabetic patients, and we anticipate it will be completed during the first quarter of calendar year 2016.
um den 01.04 herum erwartet.
http://www.riversidegazette.com/...ed-pharmaceuticals-inc-nasdaqormp/
Willkommen. Ich hoffe, dass wir bald die erwartete und hoffentliche positive News erhalten werden.
Ich frage mich, ob der Kurs bei guter News nur kurzfristig steigt und der Kurs wieder auf 6 Dollar zurückfällt oder ob er sich sich halten wird? Das kann mir natürlich keiner beantworten. Bisher habe ich die Kursanstiege nicht genutzt, um zu verkaufen und später wieder einzusteigen. Aussichten nach der "positiven" News gibt es reichlich: Partnerschaftverkündung, News der anderen Studien etc. Also tendiere ich dazu, die Aktien zu halten. Bisher wurde ich immer eines besseren belehrt.
Anbei etwas zu Oramed von heute:
http://www.investing.com/analysis/...call-activity-detected-200123784
Oramed Pharmaceuticals, Inc. (NASDAQ:ORMP) is one of those bottomed out stocks that appears to have finally started climbing out of the basement. The stock has printed a bullish engulfing candlestick pattern on Friday, breaking also a symmetrical triangle formation. Maybe this is the right time to see a more significant rebound. Volume starts to pick up (4x average). It has more room to run, so I'll be watching it on Monday and will be buying more shares once it breaks Fridays high of $7.38. Plus, the very unusual call buying (May $10) was also interesting to see. I think we might get big news very soon. Based on the 52-week technical daily chart, the MACD indicator is now going up showing a positive swing.
http://www.chinabiotoday.com/articles/20151120
Grundsätzlich halte ich es lieber so, dass ich mich zur aktuellen Kursentwicklung nicht äußere. Die Analystenreports sind ja hinlänglich bekannt. Phantasiediskussionen von $500 (Larryharry-yahoo-board) sind m.E. fruchtlos, wenn auch manchmal lustig zu lesen.
kann keiner voraussagen. Ich kann mir vorstellen, dass die Aktionäre aufgrund des starken Rücksetzers nach dem rasanten Kursanstieg mit Verkündung der 2a Studienergebnisse vorsichtiger nach Verkündung der 2b-Ergebnisse handeln werden. Der Kurs wird dabei nicht wie erhofft ansteigen, sondern erst nach und nach mit weiteren positiven News. Aber das ist alles Spekulation und daher halte ich mich auch zurück. Daher sammeln wir weiter Fakten. Anbei die neue April Präsentation:
http://www.oramed.com/investors/corporate-presentation/
Wenn ich tippen müsste sag ich morgen rot - Tendenz Richtung GD100 bei 7,30USD
Außer es passiert was überraschendes.
Allerdings wollen die diesen Quartal schon Resultate rausbringen, heißes Eisen die Nummer hier :-)
"We are pleased with the successful and timely completion of this comprehensive study," stated Oramed CEO Nadav Kidron. "We look forward to reporting top-line results shortly."
...erfolgreicher und rechtzeitiger Abschluss der umfassenden Studie...