• Aralez (ARLZ) PDUFA of YOSPRALA for secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers

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    Biotech Forecast
    Clinical and Regulatory
    Event Type: PDUFA
    Timing: 09/14/2016
    Designation(s): None

    This event is set for a specific date and makes planning easier. However, specific dates may change.
    FDA special designations may increase the likelihood of success and decrease the time to approval.
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    Disease and Treatment
    Disease: Cardiovascular
    Indication: secondary prevention of cardiovascular disease
    Lead Indication?: Yes
    Treatment Name: YOSPRALA

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: Aralez Pharmaceuticals
    Stock Symbol: ARLZ
    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://ir.aralez.com/phoenix.zhtml?c=254163&p=irol-newsArticle&ID=2148457
    http://ir.aralez.com/phoenix.zhtml?c=254163&p=irol-newsArticle&ID=2151050
    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

     Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) ("Aralez" or the "Company"), a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration ("FDA") has acknowledged acceptance of the New Drug Application ("NDA") for its investigational candidate, YOSPRALA™ (PA32540/PA8140) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. The FDA Prescription Drug User Fee Act ("PDUFA") goal date for a decision is September 14, 2016.

     

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