uniQure

uniQure NV engages in the discovery, development, and commercialization of innovative gene therapies. Its discoveries intend to treat hemophilia, Huntington's disease, glybera, and cardiovascular problems. The company was founded by Sander J. van Deventer in 1998 and is headquartered in Amsterdam, the Netherlands.

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LEXINGTON, Mass. and AMSTERDAM, The Netherlands, April 26, 2021 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, announced today that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the Company's hemophilia B gene therapy program after determining the Company satisfactorily addressed all issues identified by the FDA related to a single patient diagnosed with hepatocellular carcinoma (HCC) in the HOPE-B pivotal trial.

uniQure Announces FDA Removes Clinical Hold on Hemophilia B Gene Therapy Program

Publication in Science Translational Medicine shows local striatal delivery of microRNA-gene therapy results in widespread brain huntingtin protein lowering in Huntington's disease minipigs Publication in Science Translational Medicine shows local striatal delivery of microRNA-gene therapy results in widespread brain huntingtin protein lowering in Huntington's disease minipigs

uniQure Announces Publications of Preclinical Data for AMT-130 in Huntington's Disease Showing Safety of Administration in NHPs and Widespread Long-Term HTT-Lowering in the Brain

uniQure has submitted data to the FDA that suggest that etranacogene dezaparvovec (AMT-061) is highly unlikely to be the cause of liver cancer in a patient in the pivotal trial. FTC review of the transaction with CSL Behring is ongoing and is projected to close during the second quarter of 2021.

uniQure: A High-Risk, High-Reward Investment Opportunity

~ Enrollment of second dose cohort expected to begin in 3Q 2021 ~

uniQure Announces Completion of Enrollment in First Cohort of Phase I/II Clinical Trial of AMT-130 for the Treatment of Huntington's Disease

LEXINGTON, Mass. and AMSTERDAM, April 01, 2021 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced its participation in the following upcoming virtual investor and scientific conferences:

uniQure to Participate in Multiple Upcoming Industry Conferences in April

We believe that uniQure stock (NASDAQ: QURE), a gene therapy company, is a good buying opportunity at the present time. QURE stock trades near $30 currently and it is, in fact, down 53% from its pre-Covid high of $65 in February 2020 – just before the coronavirus pandemic hit the world.

Should You Buy uniQure Stock At $30?

Regulators froze uniQure's trial of its gene therapy for hemophilia in December when one of the 54 treated patients developed liver cancer.

uniQure Stock Is Higher After Investigators Conclude Its Gene Therapy Treatment Was Unlikely to Have Caused a Patient's Cancer

Biotech company Uniqure said Monday an investigation shows its hemophilia B gene therapy likely wasn't the culprit in a patient's cancer diagnosis. QURE stock popped on the news report.

Uniqure Stock Pops After Gene Therapy Acquitted In Cancer Diagnosis

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Humanigen, Inc. (NASDAQ: HGEN), uniQure N.V. (NASDAQ: QURE), bluebird bio, Inc. (NASDAQ: BLUE) and Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) were among the biotech gainers on Monday.

Why Humanigen, uniQure, bluebird bio, Amphastar Are Rallying Monday

Uniqure NV (NASDAQ: QURE) has reported results of a comprehensive investigation into the case of hepatocellular carcinoma (HCC) diagnosed in one patient in the HOPE-B pivotal trial of etranacogene dezaparvovec, its hemophilia B gene therapy candidate. What Happened: The trial was put on clinical last year in December, following the submission of a safety report in mid-December relating to a possibly related severe adverse event associated with a preliminary diagnosis of hepatocellular carcinoma in one patient.

Uniqure's Hemophilia B Gene Therapy Unlikely To Be Cause Of Liver Cancer Reported In One Patient

~ Independent investigation shows that etranacogene dezaparvovec is highly unlikely to be the cause of HCC in HOPE-B pivotal trial ~

uniQure Announces Findings from Reported Case of Hepatocellular Carcinoma (HCC) in Hemophilia B Gene Therapy Program

uniQure (QURE) delivered earnings and revenue surprises of 98.72% and -59.79%, respectively, for the quarter ended December 2020. Do the numbers hold clues to what lies ahead for the stock?

UniQure (QURE) Reports Q4 Loss, Lags Revenue Estimates

~ Six patient procedures now completed in Phase I/II for Huntington's disease, including two procedures conducted in February 2021, with full enrollment of first cohort expected mid-2021 ~

uniQure Announces 2020 Financial Results and Highlights Recent Company Progress

UniQure (QURE) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

UniQure (QURE) to Report Q4 Results: Wall Street Expects Earnings Growth

Shares of UniQure gained 7.2% in trading on Monday after the company said an independent data safety monitoring board said there were no safety concerns in a Phase 2/3 clinical trial for its experimental Huntington's disease treatment. The board has reviewed six months of safety data for the first two patients enrolled in the randomized, double-blind study.

UniQure's stock rallies 7% on positive safety data for Huntington's disease treatment

~ No Significant Safety Concerns Observed ~

uniQure Announces Positive Recommendation from Data Safety Monitoring Board of Phase I/II Clinical Trial of AMT-130 for the Treatment of Huntington's Disease

LEXINGTON, Mass. and AMSTERDAM, The Netherlands, Feb. 01, 2021 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced its participation in the following upcoming virtual investor and scientific conferences:

uniQure to Participate in Multiple Upcoming Industry Conferences in February

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Crispr Therapeutics, Editas Medicine and Intellia Therapeutics were ablaze Monday as all three genetics stocks touched highs. Uniqure stock fell on a clinical hold for its gene therapy test.

Genetics Stocks Ablaze: Editas, Crispr, Intellia Rocket; Uniqure Dives

A clinical hold is weighing on the biotech's shares today.

Why uniQure Stock Is Tanking Today

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Uniqure NV (NASDAQ: QURE) shares are moving sharply to the downside after the gene therapy company announced a setback to its clinical study. What Happened: Lexington, Massachusetts-based uniQure said the FDA has placed its Hemophilia B gene therapy program, including the late-stage HOPE-B study, on clinical hold.

UniQure Plunges As FDA Slaps Clinical Hold On Hemophilia B Gene Therapy Study On Possible Liver Cancer Link

Company to hold conference call today at 8:30 a.m. ET Company to hold conference call today at 8:30 a.m. ET

uniQure Announces Clinical Update on Hemophilia B Gene Therapy Program

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~ Sustained FIX Activity at Therapeutic Levels1 with a Mean of 44% of Normal at Two Years After Administration of Etranacogene Dezaparvovec in Phase IIb Study ~

uniQure Announces Two-Year Follow-Up Data from the Phase IIb Study of Etranacogene Dezaparvovec and Long-Term Follow-Up Data for AMT-060 in Patients with Hemophilia B

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The health care sector as a whole has been a top performer this year, and there is every reason to believe that strong performance will carry through to 2021.

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