• Valeant (VRX) PDUFA of RELISTOR for Opioid-Induced Constipation

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    Clinical and Regulatory
    Event Type: PDUFA
    Timing: 07/19/2016
    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: Opioid-Induced Constipation
    Lead Indication?: No
    Treatment Name: RELISTOR (methylnaltrexone bromide)

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

    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: Positive
    Event Discussion: Forums
    Event Announcement(s): http://ir.progenics.com/releasedetail.cfm?ReleaseID=963260
    Partnership: Yes

    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


    LAVAL, Quebec  and  TARRYTOWN, N.Y. ,  April 4, 2016  /CNW/ --  Valeant Pharmaceuticals International, Inc.  ( NYSE : VRX) (TSX: VRX) and  Progenics Pharmaceuticals, Inc.  (Nasdaq: PGNX) today announced that the  U.S. Food and Drug Administration  (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Oral RELISTOR (methylnaltrexone bromide) new drug application (NDA) by three months to  July 19, 2016 .  The  FDA  extended the action date to allow for a full review of  Valeant's  responses to recent information requests from the  FDA .


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