• OPKO (OPK) PDUFA of Rayaldee for Secondary Hyperparathyroidism

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    Clinical and Regulatory
    Event Type: PDUFA
    Timing: 10/22/2016
    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: Secondary Hyperparathyroidism
    Lead Indication?: No
    Treatment Name: RAYALDEE® (calcifediol)

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: OPKO
    Stock Symbol: OPK
    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://investor.opko.com/releasedetail.cfm?ReleaseID=976439
    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

    MIAMI --(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE:OPK) announced that the  U.S. Food and Drug Administration  (FDA) has approved RAYALDEE®(calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. RAYALDEE is a patented extended release product containing 30 mcg of a prohormone called calcifediol (25-hydroxyvitamin D3).

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