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May 27, 2014
05:53 EDTQUREuniQure announces successful transfection of liver cells with AAV5
uniQure announced successful transfection of liver cells with the porphobilinogen deaminase gene, or PBGD, from an ongoing Acute Intermittent Porphyria, or AIP, dose-escalation Phase I trial conducted in collaboration with the AIPGENE Consortium, a pan-European collaboration. The results also provided evidence that the AAV5 vector from uniQure's bacculovirus production platform is safe by inducing liver cell transfection in AIP patients without liver enzyme perturbations at the tested dose levels. AMT-021 aims to provide long-term normalization of the PBGD protein in order to prevent acute AIP attacks and the associated complications. The ongoing Phase I trial, conducted by Digna Biotech as part of the AIPGENE Consortium, has enrolled eight patients with severe AIP. The study's primary objective is to assess the safety of systemic administration and to determine the maximum tolerated dose of AMT-021. Secondary objectives include exploring urinary levels of toxic metabolites to determine their adequacy as biomarkers of treatment effect. uniQure received orphan drug designation for AMT-021 in 2009 from the European Medicines Agency.
News For QURE From The Last 14 Days
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August 28, 2015
16:10 EDTQUREPoint72 Asset reports 5.0% passive stake in uniQure
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08:50 EDTQUREuniQure price target lowered to $44 from $50 at Leerink
Leerink lowered its price target to $44 from $50 on uniQure after the company's Q2 report and pipeline update, noting that management said it is reassessing its development options for Glybera in the U.S. after the FDA said another trial would be required to support BLA filing. The firm said the company's key pipeline programs are on track, with initial data from hemophilia B and Sanfilippo B phase 1 trials expected in the second half, and keeps its Outperform rating on uniQure shares.
08:21 EDTQUREuniQure likely to delay Glybera U.S. registration indefinitely, says WallachBeth
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07:25 EDTQUREuniQure weakness creates buying opportunity, says H.C. Wainwright
After uniQure reported a lower than expected per share loss, H.C. Wainwright believes that Hemphilia B is a key value driver for the stock. The firm notes that in a previous Phase 1 trial the same gene cassette being used by the company in an upcoming trial demonstrated continuous expression greater than 5% at the high dose and improved median bleeding episodes by 90%. The firm thinks that the stock should rise sharply if the current trial yields similar results. It keeps a $39 price target and Buy rating on the shares.
August 27, 2015
05:36 EDTQUREuniQure reports Q2 EPS (EUR 87c) vs. (EUR 51c) last year
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