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Oramed Pharmaceuticals Inc. (ORMP)

NasdaqCM - NasdaqCM Delayed Price. Currency in USD
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10.71+1.21 (+12.74%)
At close: 4:00PM EDT
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Previous Close9.50
Bid8.90 x 1000
Ask14.00 x 3500
Day's Range9.55 - 10.87
52 Week Range5.70 - 10.87
Avg. Volume56,436
Market Cap142.67M
PE Ratio (TTM)-11.30
EPS (TTM)-0.95
Earnings DateN/A
Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est25.00
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  • GuruFocus.com2 days ago

    Oramed Now Has a Clear Path to Market With Oral Insulin

    A look at the most recent announcement about the company's efforts to bring oral insulin to market in the US

  • Zacks Small Cap Research20 days ago

    Oramed (ORMP): Successful Meeting with FDA for Oral Insulin

    By Grant Zeng, CFA NASDAQ:ORMP The FDA Meeting Earlier today (Sept. 5, 2017), Oramed Pharmaceuticals Inc. (NASDAQ:ORMP) announced that it has successfully concluded a meeting with the US FDA regarding ...

  • Oramed Announces Successful Meeting with FDA for Oral Insulin
    PR Newswire20 days ago

    Oramed Announces Successful Meeting with FDA for Oral Insulin

    JERUSALEM, Sept. 5, 2017 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (ORMP) (ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it has successfully concluded its meeting with the U.S. Food and Drug Administration (FDA) regarding ORMD-0801, the Company's novel oral insulin formulation. At the meeting, the FDA gave clear guidance that the regulatory pathway for submission of ORMD-0801, would be a Biologics License Application (BLA).  Such a pathway would grant a full 12 years of marketing exclusivity for ORMD-0801 if approved.  On top of this, an additional six months of exclusivity can be granted if the product also receives approval for use in pediatric patients. The FDA confirmed that the approach to nonclinical toxicology, CMC and qualification of excipients would be driven by their published guidance documents, consistent with the Company's expectations.  They also made specific recommendations for clinical trials designed to provide pivotal data prior to registration.