uniQure (QURE) Reports Q2 Loss of EUR0.51/Share
uniQure (NASDAQ: QURE) reported Q2 EPS of (EUR0.51), versus (EUR0.87) reported last year. Revenue for the quarter came in at EUR1.04 million, versus EUR1.62 million reported last year.
Pipeline Updates
- Hemophilia B: Dosing is underway in the Phase I/II study of AMT-060 in hemophilia B and the Company anticipates providing a preliminary readout of safety and efficacy data from the initial patients in the second half of 2015.
- Sanfilippo B: One-year follow-up results of the Phase I/II clinical trial conducted in Sanfilippo B patients are scheduled to be presented by the Institut Pasteur, uniQure's collaborator, at two scientific meetings in the second half of 2015. Details related to these presentations are provided at the end of this release.
- Glybera®: uniQure remains on target to initiate in early 2016 a U.S.-based clinical study for Glybera® (alipogen tiparvovec) to support post-approval requirements in the EU. In the Company's communications with the FDA regarding the U.S. regulatory pathway for Glybera, the FDA has stated they will require more than one additional clinical study to support a BLA filing. The Company is currently assessing its options for pursuing regulatory approval of Glybera in the U.S.
- Parkinson's Disease: The investigator-initiated Phase I clinical study of glial cell line-derived neurotrophic factor (GDNF) in Parkinson's disease, led by Krystof Bankiewicz, MD, PhD, at the University of California, San Francisco, has completed enrolment of its first dosing cohort and initiated dosing of its second cohort in the third quarter of 2015.
For earnings history and earnings-related data on uniQure (QURE) click here.
