• Antares Pharma (ATRS) NDA Submission of QuickShot Testosterone for Male Hypogonadism

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    Biotech_Forecast
    Clinical and Regulatory
    Event Type: NDA Submission
    Timing: Q4 2016
    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: Endocrine
    Indication: Male Hypogonadism
    Lead Indication?: No
    Treatment Name: QuickShot Testosterone

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: Antares Pharma
    Stock Symbol: ATRS
    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://www.antarespharma.com/application/files/3014/7454/9504/QST_005_safety_study_final.pdf
    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

    ANALYSIS OF 26 WEEK SAFETY DATA FROM STUDY QST-15-005 COMPLETED, NDA SUBMISSION REMAINS ON TRACK FOR FOURTH QUARTER 2016

    EWING, NJ, September 22, 2016 -- Antares Pharma, Inc. (NASDAQ: ATRS) today announced safety results from the dose-blinded, multiple-dose, concentration-controlled, 26-week phase 3 study of QuickShot® Testosterone (QST) administered subcutaneously once each week to adult males with hypogonadism. The study, QST-15-005, included a screening phase, a titration phase and a treatment phase for evaluation of safety and tolerability, including laboratory assessments, adverse events and injection site assessments.


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