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2023-05-15 08:26:38 ET Dutch biotech uniQure N.V. ( NASDAQ: QURE ) added ~7% pre-market Monday after announcing an agreement to sell a portion of royalty rights expected to receive from Australian drugmaker CSL Limited ( OTCQX:CSLLY ) in relation to the gene therapy Hemgenix...
~ uniQure to receive $375 million upfront cash payment ~ ~ Under the existing agreement with CSL Behring, uniQure retains the rights to future milestones totaling up to $1.5 billion and maintains an interest in HEMGENIX ® royalties ~ ~ Capped royalty financing provi...
2023-05-09 08:42:56 ET uniQure press release ( NASDAQ: QURE ): Q1 GAAP EPS of -$1.63 misses by $0.73 . Revenue of $5.33M (+197.8% Y/Y). As of March 31, 2023, the Company had cash and cash equivalents and investment securities of $315.3 million. The Company expe...
~ Clinical update from U.S. Phase I/II trial in Huntington’s disease expected in second quarter 2023 ~ ~ Continued progress towards initiating two new Phase I/II clinical studies for AMT-260 in refractory temporal lobe epilepsy and AMT-162 in SOD1-ALS ~ LEXINGTON, Mass and ...
LEXINGTON, Mass. and AMSTERDAM, May 02, 2023 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that 12 data presentations, including two oral presentations, will be deliver...
2023-03-21 07:43:24 ET A top FDA official said Monday that the agency needs to consider accelerated approval, a regulatory avenue commonly used to expedite the market entry of cancer drugs, for gene therapies. Dr. Peter Marks, who heads the FDA's biologics unit, said that the agency...
uniQure press release ( NASDAQ: QURE ): FY GAAP EPS of -$2.71 beats by $0.98 . Revenue of $106.48M (-79.7% Y/Y) beats by $83.27M . As of December 31, 2022, the Company had cash and cash equivalents and investment securities of $392.8 million. The Company expects cash a...
~ Achieved U.S. and European Commission marketing approvals of first and only gene therapy for adults with hemophilia B ~ ~ Advancing development of AMT-130 for patients with Huntington’s disease – clinical update from U.S. Phase I/II trial expected in seco...
~ Data follow the historic approval of the first gene therapy for hemophilia B, which has been shown in clinical trials to reduce the rate of annual bleeds, reduce or eliminate the need for prophylactic therapy and generate elevated and sustained factor IX levels for years after a one-time infu...
CSL's HOPE-B Data Published in the New England Journal of Medicine, Demonstrating Efficacy and Durability of HEMGENIX® (etranacogene dezaparvovec-drlb) PR Newswire Data follow the historic approval of the first gene therapy for hemophilia B, which reduces the rate of annu...
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~ uniQure maintains preferential access to industry-leading manufacturing capabilities to support its pipeline of gene therapy candidates ~ ~ Immediate reduction in cash burn, projected to save $40 million annually ~ LEXINGTON, Mass. and AMSTERDAM, July 23, 2024 (GLOBE NEWSWIRE) -...
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