UniQure’s AMT-060 for Hemophilia B receives Breakthrough Therapy designation

UniQure announced this morning that their lead asset, AMT-060 received Breakthrough Therapy designation by the FDA. With this designation come several commercialization advantages including expedited development and review times. To qualify for Breakthrough Therapy designation, the investigational therapy must treat a life threatening disease and have preliminary clinical evidence demonstrating a substantial improvement over existing therapies.

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Find the press release here: http://www.uniqure.com/investors-newsroom/press-releases.php

For more on Breakthrough Therapies, see here: http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm

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