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.
UniQure is one of AMP Biotech Research's quarterly picks for Q1 2017. AMP is a biotech research firm that publishes a quarterly list of companies with attractive valuations and near-term catalysts. To see all of AMP's picks for Q1 2017, go to www.ampbioresearch.com.
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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