• Galmed (GLMD) Phase 2b Topline Results of Aramchol in NASH

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    Biotech Forecast
    Clinical and Regulatory
    Event Type: Phase 2b Results
    Timing: Q1 2018
    Designation(s): None

    This event is set for a broad date range and therefore the exact timing is unknown. This adds a degree of risk.
    FDA special designations may increase the likelihood of success and decrease the time to approval.
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    Disease and Treatment
    Disease: Other
    Indication: NASH
    Lead Indication?: Yes
    Treatment Name: Aramchol

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: Galmed Pharmaceuticals
    Stock Symbol: GLMD
    Shares Traded: NASDAQ

    The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
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    Event Status
    Event Outcome: Ongoing
    Event Discussion: Forums
    Event Announcement(s): http://galmedpharma.investorroom.com/2016-03-22-Galmed-Pharmaceuticals-Reports-Full-Year-2015-Financial-Results-and-Provides-Business-Update
    Partnership: No

    Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
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    Detailed Event Description from Company Announcement

    Quote

    Importantly, worldwide, we have now screened over 400 subjects for the ARREST Study.  As of March 20th, 2016, we had randomized 75 patients and have another 15 subjects that are eligible to be randomized.  In addition, 68 subjects are currently within the screening process, which normally takes between 6-8 weeks.  We expect the 120th patient to be randomized by the end of the second quarter, 2016, and the 240th patient by the end of 2016.  Based on the current rate of screening and enrollment, we now expect results from the Interim Analysis to be available by December 2016, or early first-quarter 2017, and top-line data for the complete study by the first quarter, 2018, inclusive of the three-month follow-up period.  Now that we have six months of active global screening in the ARREST Study behind us, we feel very comfortable with our estimates

     


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