MiamiGent
2 years ago
QURE
$26.36 +3.36 (+14.61%)
As of Nov-23-20224:00:00 PM ET
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FDA Approves UniQure's Hemgenix, First Hemophilia B Gene Therapy For Adults
BENZINGA 8:12 AM ET Nov-23-2022
UniQure N.V.'s (NASDAQ:QURE) partner CSL Limited (OTC:CSLLY) has received FDA approval for Hemgenix (etranacogene dezaparvovec-drlb), a one-time gene therapy for hemophilia B.
CSL licensed the exclusive global rights to Hemgenix from uniQure in May 2021.
UniQure has received about $500 million so far from CSL and will also be eligible to get up to an additional $1.5 billion in commercial milestone payments and royalties.
Cowen analyst Joseph Thome said that Hemgenix's price of $3.5 million is higher than the brokerage's estimated $1.9 million, but its consultants have been optimistic about the therapy's uptake, Reuters reported.
Results from the pivotal HOPE-B trial support the FDA approval, the largest gene therapy trial in hemophilia B.
Results from the study demonstrated that Hemgenix allowed patients to produce mean factor IX activity of 39% at six months and 36.7% at 24 months post-infusion.
Seven to 18 months post-infusion, the mean adjusted annualized bleeding rate (ABR) for all bleeds was reduced by 54% compared to the six-month lead-in period on factor IX prophylactic replacement therapy (4.1 to 1.9).
In addition, 94% of patients treated with Hemgenix discontinued prophylaxis and remained free of previous continuous routine prophylaxis therapy.
The FDA has already cleared two gene therapies, Zynteglo and Skysona, from Bluebird bio Inc (NASDAQ: BLUE) in August and September, respectively.
redsox17
8 years ago
Great newsGo QURE
uniQure N.V. (NASDAQ:QURE) announced the completion of a company-wide strateghttp://www.benchmarkmonitor.com/2016/11/17/uniqure-n-v-nasdaqqure-announced-the-completion-of-a-company-wide-strategic-review/ic review
uniQure N.V. (NASDAQ:QURE), announced the completion of a company-wide strategic review aimed at refocusing its pipeline, consolidating its manufacturing and enhancing overall execution to drive shareholder value. As a result of this initiative, the Company will prioritize programs in hemophilia B, Huntingtonโs disease and those associated with its landmark collaboration with Bristol-Myers Squib (BMS) in cardiovascular disease.
uniQure N.V. (NASDAQ:QURE), a Healthcare sector firm, traded 495604 shares in last trading session with closing price of $7.04 per share. Company gross margin stands at 94.90% whereas its return on investment (ROI) is -49.30%. Stock value has moved between $6.64 โ 22.71 in last one year. Analystโs mean target price for uniQure N.V. (NASDAQ:QURE) is $30.10 while analysts mean recommendation is 1.60. QURE EPS growth this year is -49.60%.