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    Chiasma (CHMA) PDUFA of Mycapssa for acromegaly

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    Biotech Forecast
    Clinical and Regulatory
    Event Type: PDUFA
    Timing: 04/15/2016
    Designation(s): Orphan Drug

    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: acromegaly
    Lead Indication?: Yes
    Treatment Name: Mycapssa™ (octreotide)

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: Chiasma
    Stock Symbol: CHMA
    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.chiasmapharma.com/phoenix.zhtml?c=254057&p=irol-newsArticle&ID=2148299
    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

    Quote

    As we draw closer to our April 15, 2016 Prescription Drug User Fee Act (PDUFA) target date, we are keenly focused on increasing awareness of Chiasma among key constituents while also raising awareness about acromegaly and the unmet needs of patients with this rare disease.

     


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