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Fly News Breaks for December 9, 2019
ONCE, QURE
Dec 9, 2019 | 11:45 EDT
uniQure (QURE) updated FIX activity and durability from AMT-060 and its AMT-061 programs at ASH, with the former approaching four years and the latter at the one-year time point, H.C. Wainwright analyst Debjit Chattopadhyay tells investors in a research note. The analyst believes AMT-061 has a "best in class" profile for subjects with hemophilia B over Spark Therapeutics' (ONCE) SPK-9001. uniQure's ongoing HOPE-B registration study with a topline readout during Q4 of 2020 should position AMT-061 as the "first one-and-done" gene therapy for hemophilia B, contends Chattopadhyay, who has a Buy rating on the shares with a $73 price target.
News For QURE;ONCE From the Last 2 Days
QURE
Oct 25, 2021 | 07:08 EDT
As of September 30, 2021, the Company had cash and cash equivalents of $578.5 million. The Company expects that its cash and cash equivalents will be sufficient to fund operations into the first half of 2024. In addition, under the CSL Behring Agreement, the Company is eligible to receive more than $300 million in regulatory, development, and first commercial sale milestones, $1.3 billion in additional commercial milestones, and tiered double-digit royalties of up to a low-twenties percentage of net product sales arising from the collaboration. The receipt of approximately $300 million in regulatory, development, and first commercial sale milestones would be expected to extend the cash runway by approximately 12-18 months.
QURE
Oct 25, 2021 | 07:06 EDT
Reports Q3 revenue $2M, consensus $2.52M. "We continue to make strong progress across our clinical trials and research programs, and CSL Behring is making significant strides towards a BLA submission for etranacogene dezaparvovec in hemophilia B, which is expected in the first half of 2022," stated Matt Kapusta, chief executive officer at uniQure. "Before the end of this year, we look forward to announcing clinical data from our Huntington's disease gene therapy program, including preliminary data on the first four patients in our ongoing U.S. Phase I/II study of AMT-130. Additionally, top-line 78-week follow-up data on all HOPE-B pivotal study patients is expected to be announced by CSL Behring in late 4Q2021."