• Advanced Accelerator Applications (AAAP) Phase 3 Results of Lutathera for Neuroendocrine Tumors

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    Clinical and Regulatory
    Event Type: Phase 3 Results
    Timing: 05/11/2016
    Designation(s): Orphan Drug, Priority Review

    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: Oncology
    Indication: Neuroendocrine tumor diagnosis
    Lead Indication?: Yes
    Treatment Name: Lutathera (177-Lu-Dotatate)

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: Advanced Accelerator Applications
    Stock Symbol: AAAP
    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: Positive
    Event Discussion: Forums
    Event Announcement(s): http://www.sec.gov/Archives/edgar/data/1611787/000095010316011371/dp63730_6k.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

    25 February 2016, Saint-Genis-Pouilly, France – Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA” or “the Company”), an international specialist in molecular nuclear medicine, today announced both updated data from the pivotal Phase 3 NETTER-1 study investigating the treatment of Lutathera (177-Lu-Dotatate) in patients with inoperable, progressive, somatostatin receptor positive midgut neuroendocrine tumors (midgut NETs) as well as Prescription Drug User Fee Act (PDUFA) date update for Somakit-TATE New Drug Application (NDA).

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