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A big approval for a gene therapy sent the biotech's stock higher.
uniQure (QURE) shares rise after its partner CSL Limited received FDA nod for one-time gene therapy, Hemgenix, for treating adults with Hemophilia B.
The FDA just approved the most expensive drug ever — a hemophilia gene therapy from Carlisle and UniQure — and QURE stock popped Wednesday. The post The FDA Just Approved The Most Expensive Drug Ever — Sending UniQure Stock On A Warpath appeared first on Investor's Business Daily.
uniQure outlicensed AMT-061, EtranaDez, to CSL Behring who will market the gene therapy for hemophilia B. EtranaDez has a PDUFA date in November and if approved, uniQure will collect a $175 m milestone payment upon commercial launch strengthening their cash position.
uniQure N.V. has U.S. and European approvals possible of etranacogene dezaparvovec for treatment of Hemophilia B before end of 2022 and early 2023 respectively. uniQure N.V. has already tapped a partner that is licensed and will help commercialize the drug by the name of CSL Behring.
The company is temporarily delaying higher-dose procedures of experimental gene therapy AMT-130.
uniQure (QURE) delivered earnings and revenue surprises of 12.50% and 97.47%, respectively, for the quarter ended June 2022. Do the numbers hold clues to what lies ahead for the stock?
This can be attributed to the company reporting positive findings from clinical trials for its Huntington's Disease treatment - AMT-130.
uniQure (QURE) posts safety and biomarker data from the 10 patients enrolled in the lower-dose cohort of its ongoing phase I/II study evaluating AMT-130 for treating Huntington's disease.
uniQure (QURE) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.