• ZS Pharma (ZSPH) PDUFA of ZS-9 for Hyperkalemia

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    Clinical and Regulatory
    Event Type: PDUFA
    Timing: 05/26/2016
    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: Other
    Indication: Hyperkalemia
    Lead Indication?: Yes
    Treatment Name: ZS-9 (sodium zirconium cyclosilicate)

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: ZS Pharma
    Stock Symbol: ZSPH
    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: Negative
    Event Discussion: Forums
    Event Announcement(s): http://www.sec.gov/Archives/edgar/data/1459266/000119312515268241/d66049dex991.htm
    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



    Redwood City, Calif. – July 29, 2015 – ZS Pharma, Inc. (Nasdaq: ZSPH), today announced that its New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalemia, has been accepted for filing by the United States Food and Drug Administration (FDA).

    We have been informed that the Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is May 26, 2016.



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