Oramed Pharmaceuticals Inc.

diese seitwärtsbewegung macht irgendwie unglücklich....aber immerhin besser wie abwärts.  

Vor einem Jahr noch bei 840.370  

Short Percent of Float = 5.12 %

hier noch die aktuelle sec eintragung :

http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=11505673  

alle news kommen zeitgleich als mail...  

Oramed Reports Additional Phase IIb Oral Insulin Study Data Demonstrating Significant Lowering of Glucose Levels vs Placebo

na also.  

ORAMED PHARM INC has added a news release to its Investor Relations website.
Title: Oramed Reports Additional Phase IIb Oral Insulin Study Data Demonstrating Significant Lowering of Glucose Levels vs Placebo

Date(s): 28-Jul-2016 8:15 AM

For a complete listing of our news releases, please click here  

gewartet.......vieleicht kommt nun auch der kurs wieder in schwung.  

http://www.oramed.com/wp-content/uploads/2016/07/...ly-2016-FINAL.pdf

 

Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, today reported additional data from the recently concluded Phase IIb trial of its oral insulin capsule ORMD-0801 in adults with type 2 diabetes. The data indicate a statistically significant lowering of glucose relative to placebo across several endpoints. Oramed had previously announced positive topline data showing the study successfully met its primary efficacy and safety endpoints.

"ORMD-0801 was safe and efficacious in reducing blood glucose endpoints with a promising clinically meaningful reduction in the mean 24-hour blood glucose," said Dr. Roy Eldor, Oramed's Chief Medical Director, "We look forward to preparing the groundwork for a Phase III trial as we continue to bring this revolutionary product to market."

The primary objective of the study was to evaluate the nighttime glucose lowering effect and safety of ORMD-0801 compared to a placebo. Excessive production of glucose at night is a significant challenge in diabetes management. Reducing nighttime blood glucose levels can significantly slow down the progression of diabetes and its life threatening comorbidities.

In the study, the mean nighttime glucose showed a significant difference in mean change from run-in (13.70 mg/dL for placebo vs. 1.66 mg/dL for the pooled ORMD-0801 arms with a p= 0.0117). ORMD-0801 was safe and well tolerated, with no drug related serious or severe adverse events and no statistically significant differences in laboratory values or vital signs.  

Other secondary and exploratory objectives of the study included evaluating the effect of ORMD-0801 on mean 24-hour glucose, fasting glucose, and daytime glucose. The mean 24-hour glucose showed a highly significant difference in mean change from run-in (13.26 mg/dL for placebo vs. -0.32 mg/dL for ORMD-0801, p <0.0001). The mean fasting glucose showed a highly significant difference in mean change from run-in (15.95 mg/dL for placebo vs. -0.41 mg/dL for ORMD-0801, p <0.0001). The mean daytime CGM glucose showed a highly significant difference in mean change from run-in (11.88 for placebo vs. 0.88 for ORMD-0801, p= 0.0010).

There was a statistically significant difference in change in HbA1c at Day 29 (0.20% for placebo vs.-0.01% for ORMD-0801, p= 0.0149). It is important to note that due to the kinetics of change of HbA1c, a four week study is insufficient to fully appreciate the potential positive impact of ORMD-0801 on HbA1c.

ORMD-0801 did not show a significant difference in change in morning fasting serum insulin, C-Peptide, or triglycerides.  

A conference call on the results of the Phase IIb study will be held today, July 28, 2016, at 11:00 AM ET.  Presentation slides to be used for the conference call are available at: http://www.oramed.com.

http://www.biospace.com/news_story.aspx?StoryID=427481&full=1

 

halben stunde die daten sehr gut auf......

onka : ist das nun ein weiterer meilenstein zum eintritt in den milliarden markt für die insulin pille von oramed ?    

alle Einzel-Ergebnisse sind positiv, HbA1c wurde auch gesenkt, aber dieser Wert ist aufgrund der "nur" 28 Tage dauernden Studie nicht aussagekräftig. Jetzt kommt es darauf an, wie gut die Analysten das erweiterte Ergebnis bewerten. In den USA werden die Ergebnisse bisher vorsichtig angenommen, auch wenn der Kurs um 10% gestiegen ist. Die Foren in Amerika sind ebenfalls alle ruhig. Scheint so, dass zunächst die Konferenz um 17 Uhr abgewartet wird.

Anmerkung: Die Präsentation sieht ein wenig lieblos aus und ist noch nicht von einer News begleitet. Vielleicht ist das ein positives Zeichen?!  

warten wir ab was die konferenz ergibt, und was die analysten dann daraus machen werden.

imo wieder bei   8,450,55 (6,96 %)..  

von heute zu verarbeiten........ist aber nicht so leicht..tztzzz. is halt börse....!!

vllt klapps ja morgen oder in einer woche oder in einem monat oder......in 10j.  

http://seekingalpha.com/article/...cal-results-conference?part=single

 

 

...These results suggest we will observe a further and clinically meaningful reduction in A1C in longer studies.

....In this study, no clear dose response was observed. While it may be due to lack of clear pharmacokinetic differentiation between the two dose levels studied it may very well suggest a mechanistic effect of a liver directed insulin. This would align with the sustained daylong anti-hyperglycemic effect observed in this study. We are currently planning a short dose response study to get a better understanding of this phenomenon and to ‘fine tune’ our selected doses as we move towards our planned Phase III trial.

Concluding my remarks, I want to say that we are truly encouraged by these results and see a clear path forward towards an end of Phase II meeting with the FDA and initiation of our Phase III studies. While currently under development, our Phase III program will focus on safety and long-term A1C lowering efficacy, and will include both active comparator and placebo controlled trials.

 

die notierungen ziehen wieder leicht an. der rückgang der kurse gestern war mir auch recht unerklärlich. die daten der studie 2b waren i.o. und der fortgang zur phase 3 wird ebenfalls vorangetrieben......das der langzeitzuckerwert hier nicht 100% ausgewertet werden konnte war doch klar..bei einer studiendauer von 28 tagen. der hba1c wert wird normalerweise in 8-12 wo abständen gemessen..

allso meiner ansicht steht alles auf grün.  

also wir bewegen uns egal was kommt nicht wirklich vom Fleck...bin leicht ratlos was uns wirklich mit mal nachhaltig in 2 stellige Gefilde heben soll....

Bisher läuft alles nach Plan...nur der Kurs nicht :-(  

http://www.nasdaq.com/press-release/...yment-from-htit-20160802-00685

Oramed Receives Additional $4 Million Milestone Payment From HTIT

Totaling $25.5 M in payments from HTIT received to date

 

womöglich könnten sie auch 100mio meilenstein zahlungen erhalten.....und der kurs bewegt sich nicht......??

schon ein bizzel komisch !  

auch noch mit dem bruch der 200tg linie bei 7,76$ ??

dann mal gute nacht !

 

...

Bottom line, if the upcoming results for Novo Nordisk’s Phase II oral insulin therapy are negative and Oramed proceeds to Phase III, there may be a bidding war over Oramed in a mad dash to keep the current diabetes business model alive. That means the final results of this Novo Nordisk Phase II trial for oral insulin could have profound effects on Oramed shares and its shareholders, even more than a first-hand Oramed data readout.

http://...disk-adr-nasdaqnvo-vs-oramed-pharmaceuticals-inc-nasdaqormp

 

Von Ihnen kommen bereits 7 der letzten 20 (oder weniger) positiven Bewertungen für Onka.

sehr schöner und ermutiger bericht über oramed und novo....unter diesen gesichtspunkten sitzen wir also auf einem möglichen pulverfass.....kurstechnisch...!!  

http://marketexclusive.com/...rmaceuticals-inc-nasdaqormp/24162/?icd1

 

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