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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UniQure N.V. (NASDAQ: QURE) has announced 52-week data from its Phase 3 HOPE-B gene therapy trial of etranacogene dezaparvovec to treat hemophilia B.

One Year Following Single Administration, UniQure's Hemophilia B Gene Therapy Candidate Shows Sustained Increase In Factor IX Levels

UniQure N.V. (NASDAQ: QURE) has agreed to acquire Corlieve Therapeutics and its lead program for temporal lobe epilepsy (TLE), the most common form of focal epilepsy.

UniQure Expands Gene Therapies Pipeline For Neurological Disorders With Corlieve Acquisition

~ Expands uniQure's Pipeline of Innovative Gene Therapies to Treat Neurological Disorders ~

uniQure to Acquire Corlieve Therapeutics and Advance its Gene Therapy Program to Treat Temporal Lobe Epilepsy (TLE)

~ Sustained increases in Factor IX (FIX) levels with mean FIX activity of 41.5 percent of normal in full study population one year following a single administration of etranacogene dezaparvovec ~

uniQure Announces Positive 52-Week Clinical Data from HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B and Provides Regulatory Update

LEXINGTON, Mass. and AMSTERDAM, The Netherlands, June 16, 2021 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the first two patient procedures have been completed in the higher dose, second cohort of the Phase I/II clinical trial of AMT-130 for the treatment of Huntington's disease. The initiation of patient enrollment in this 16-patient cohort follows a meeting last month of the trial's independent Data Safety Monitoring Board (DSMB) that reviewed safety data for the fully enrolled first cohort of ten patients. The Phase I/II study is a double-blind, randomized clinical trial being conducted in the United States. To date, seven patients now have been treated with AMT-130 across both trial cohorts, and five patients have received the imitation surgery.

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

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The markets were lower across the board on Tuesday afternoon. All eyes on Wall Street are focused on the two-day Federal Reserve meeting, which began Tuesday, as many are waiting to hear how the narrative on inflation is portrayed.

Alliance Data, Cimarex Energy, Myriad Genetics, Nestle and More Tuesday Afternoon Analyst Research Calls

The risk-adjusted value of the CSL Behring collaboration is well in excess of the current enterprise value. Cash now represents over 4 years of runway reducing the risk of dilution.

uniQure: Biding Time Turns To Buying Time

~ uniQure to host virtual Research & Development Day on June 22, 2021 ~ ~ uniQure to host virtual Research & Development Day on June 22, 2021 ~

UPDATE -- uniQure to Participate in Multiple Upcoming Industry Conferences in June

uniQure to Participate in Multiple Upcoming Industry Conferences in June

The independent Data Safety Monitoring Board (DSMB) has reviewed safety data for the fully enrolled first cohort of ten patients of the Phase 1/2 trial evaluating UniQure NV's (NASDAQ: QURE) AMT-130 for Huntington's disease. The DSMB recommended continued dosing in the study.

DSMB Recommends UniQure To Continue Huntington's Gene Therapy Trial Unchanged

Independent Data Safety Monitoring Board Recommends Proceeding with Second, Higher-Dose Cohort Independent Data Safety Monitoring Board Recommends Proceeding with Second, Higher-Dose Cohort

uniQure Announces Positive Recommendation to Advance Phase I/II Clinical Trial of AMT-130 for the Treatment of Huntington's Disease

~ Data Show No Clinically Significant Correlation Between Pre-Existing NAbs and FIX Activity ~

uniQure Presents HOPE-B Clinical Data Demonstrating Clinical Benefit in Hemophilia B Patients with Pre-existing Antibodies to AAV5 Vector

~ 52-week follow-up data from HOPE-B pivotal study expected to be presented later this quarter ~

uniQure Announces First Quarter 2021 Financial Results and Highlights Recent Company Progress

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Moderna, Inc. (NASDAQ: MRNA). uniQure N.V.

Why Moderna, uniQure And Novavax Are Moving Today

KING OF PRUSSIA, Pa., May 6, 2021 /PRNewswire/ -- Global biotherapeutics leader CSL Behring today announced the closing of its global Commercialization and License agreement with uniQure (NASDAQ: QURE) for etranacogene dezaparvovec (AMT-061), a novel gene therapy for the treatment of hemophilia B.

CSL Behring Announces Closing of Global Commercialization and License Agreement with uniQure for etranacogene dezaparvovec

LEXINGTON, Mass. and AMSTERDAM, The Netherlands, May 03, 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 May

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.

Earnings Preview: uniQure (QURE) Q1 Earnings Expected to Decline

LEXINGTON, Mass. and AMSTERDAM, The Netherlands, April 28, 2021 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that five data presentations, of which two are oral presentations, will be delivered at the American Society of Gene and Cell Therapy (ASGCT) Virtual 2021 Annual Meeting being held May 11-14.

uniQure Announces Presentations at Upcoming American Society of Gene and Cell Therapy (ASGCT) Annual Meeting

uniQure (QURE) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

Strength Seen in uniQure (QURE): Can Its 8.3% Jump Turn into More Strength?

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Voyager Therapeutics, Inc. (NASDAQ: VYGR), uniQure N.V. (NASDAQ: QURE), Axsome Therapeutics, Inc. (NASDAQ: AXSM), Reviva Pharmaceuticals Holdings, Inc. (NASDAQ:RVPH) and CRISPR Therapeutics AG (NASDAQCRSP) are among the biggest biotech movers in Monday's session.

Why Voyager Therapeutics, uniQure, Axsome, Reviva Pharma and Crispr Are Moving Today

Shares of UniQure gained 9.1% in trading on Monday after the company said the Food and Drug Administration had lifted a clinical hold on the hemophilia B program for its experimental gene therapy. UniQure said it now expects to share top-line data from the clinical trial sometime this quarter.

UniQure stock is up after FDA lifts clinical hold on experimental gene therapy

The Food and Drug Administration said Monday that Uniqure can resume testing its hemophilia B gene therapy, and QURE stock popped. The hold followed a patient's liver cancer diagnosis.

Uniqure Stock Pops After FDA Says It Can Resume Gene Therapy Tests

The FDA has removed the clinical hold on uniQure NV's (NASDAQ: QURE) hemophilia B gene therapy program after determining the company had satisfactorily addressed all identified issues related to a single patient diagnosed with hepatocellular carcinoma (HCC) in the HOPE-B pivotal trial. Last month, a comprehensive investigation into the case of HCC diagnosed in one patient in the HOPE-B trial was concluded.

UniQure's Stock Is Trading Higher As FDA Lifts Clinical Hold On Its Hemophilia B Gene Therapy Program

The stock price of Uniqure NV (NASDAQ: QURE) has increased by over 5% pre-market. This is why it happened.

QURE Stock: Over 5% Increase Pre-Market Explanation

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

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