• Lipocine (LPCN) PDUFA of LPCN 1021 for Testosterone Replacement Therapy

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    Biotech Forecast
    Clinical and Regulatory
    Event Type: PDUFA
    Timing: 06/28/2016
    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: Endocrine
    Indication: testosterone replacement therapy
    Lead Indication?: Yes
    Treatment Name: LPCN 1021

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: Lipocine
    Stock Symbol: LPCN
    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.lipocine.com/releasedetail.cfm?ReleaseID=960051
    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


    Announced the acceptance of its 505(b)(2) New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. The FDA has assigned a Prescription Drug User Fee Act ("PDUFA") action date of June 28, 2016, for completion of the review of the NDA for LPCN 1021. Additionally, the 74-day filing communication letter did not mention a need to convene an Advisory Committee for advice on the NDA for LPCN 1021.


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