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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Wednesday, uniQure announced interim phase 1/2 results for its experimental Huntington's disease gene therapy. Results from the high-dose cohort raised more questions than they answered.

Why uniQure Stock Cratered This Week

uniQure (QURE) stock declines after the company announces mixed results from its biomarkers analysis in the early-to-mid-stage study of AMT-130 in Huntington's disease.

uniQure (QURE) Falls on Mixed Huntington's Disease Study Results

LOS ANGELES--(BUSINESS WIRE)---- $QURE #QURE--The Schall Law Firm Announces it is Investigating Claims Against uniQure N.V. and Encourages Investors with Losses to Contact the Firm.

INVESTIGATION REMINDER: The Schall Law Firm Announces it is Investigating Claims Against uniQure N.V. and Encourages Investors with Losses to Contact the Firm

LOS ANGELES, CA / ACCESSIWRE / June 22, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of uniQure N.V. ("uniQure" or "the Company") (NASDAQ:QURE) for violations of the securities laws.

SHAREHOLDER ACTION ALERT: The Schall Law Firm Announces it is Investigating Claims Against uniQure N.V. and Encourages Investors with Losses In Excess of $250,000 to Contact the Firm

INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against uniQure N.V. and Encourages Investors with Losses to Contact the Firm

uniQure reported interim data from a phase 1/2 study of AMT-130 in treating Huntington's disease. The results for the low dose of the gene therapy were promising.

Why uniQure Stock Is Crashing Today

uniQure shares tumbled by more than 40% shortly at the market open on Wednesday after it released mixed results from a Phase 1/2 clinical trial involving its Huntington's disease treatment AMT-130. The company reported that AMT-130, a one-time administered investigational gene therapy, continues to be well-tolerated with a manageable safety profile in both its low-dose and high-dose cohort.

uniQure shares plunge on mixed results from Huntington's disease trial

Uniqure unveiled mixed results for its study of a Huntington's disease treatment on Wednesday, and QURE stock crashed to a six-year low.

Uniqure Crashes To Six-Year Low On Muddy Results For Huntington's Gene Therapy

~ AMT-130 continues to be generally well-tolerated across both dose cohorts ~ ~ Patients treated with AMT-130 show preserved function compared to baseline and clinical benefits relative to natural history of the disease ~ ~ Neurofilament Light Chain (NfL) in cerebrospinal fluid (CSF) was below baseline at 24 months in patients treated with the low-dose of AMT-130 and declining towards baseline at 12 months in patients treated with the high-dose of AMT-130 ~ ~ Suppression of CSF mHTT in low-dose cohort supports AMT-130 target engagement; Greater variability observed in high-dose cohort ~ ~ Promising data support continuing clinical development of AMT-130 and pursuing regulatory interactions to discuss late-stage development ~ ~ Investor conference call and webcast today at 8:30 a.m. ET ~ LEXINGTON, Mass.

uniQure Announces Update on U.S. Phase I/II Clinical Trial of AMT-130 Gene Therapy for the Treatment of Huntington's Disease

Milestone payment triggered by first commercial sale of HEMGENIX® in U.S. by CSL Behring Milestone payment triggered by first commercial sale of HEMGENIX® in U.S. by CSL Behring

uniQure announces achievement of $100 million milestone related to hemophilia B gene therapy

CSL Ltd

HEMGENIX®, the first and only FDA approved gene therapy for hemophilia B, has been proven to elevate and sustain factor IX levels for years, significantly reduce the rate of annual bleeds versus standard of care, and reduce or eliminate the need for prophylactic treatment in 94% of patients (51 out of 54) after a one-time infusion KING OF PRUSSIA, Pa. , June 20, 2023 /PRNewswire/ -- Global biotechnology leader CSL Behring today announced that the first patient has received U.S. Food and Drug Administration (FDA) approved HEMGENIX® (etranacogene dezaparvovec-drlb) for hemophilia B in the United States.

CSL Behring Announces the First Patient Has Received FDA-Approved HEMGENIX® (etranacogene dezaparvovec-drlb) for Hemophilia B

uniQure secured FDA approval late last year and EMA approval in Q1 2023 for its AMT-061 Hemophilia B treatment. This paves the way for its commercialization in the US and EU. It also has a healthy R&D pipeline, with its Huntington's disease treatment in Phase I/II trials and several others in preclinical trials.

Market Is Still Not Pricing In The FDA And EU EMA Approvals For uniQure

uniQure's strong financial performance and remarkable revenue growth highlight the company's continued upward trajectory, making it a promising investment opportunity. Innovative gene therapies such as HEMGENIX for hemophilia B and AMT-130 for Huntington's disease pave the way for a complete transformation of current medical treatments.

uniQure: Financials And Pipeline Signal A Promising Outlook For Investors

~ uniQure to receive $375 million upfront cash payment ~ ~ Under the existing agreement with CSL Behring, uniQure retains the rights to future milestones totaling up to $1.5 billion and maintains an interest in HEMGENIX ® royalties ~ ~ Capped royalty financing provides uniQure non-equity-dilutive capital to advance its broad gene therapy pipeline, including AMT-130 for Huntington's disease ~ LEXINGTON, Mass. and AMSTERDAM, The Netherlands, May 15, 2023 (GLOBE NEWSWIRE) -- uniQure N.V.

uniQure Announces Sale of Royalty Interest in HEMGENIX® for Up To $400 Million

UniQure (QURE) came out with a quarterly loss of $1.63 per share versus the Zacks Consensus Estimate of a loss of $1.02. This compares to loss of $1 per share a year ago.

UniQure (QURE) Reports Q1 Loss, Lags Revenue Estimates

~ Clinical update from U.S. Phase I/II trial in Huntington's disease expected in second quarter 2023 ~ ~ Continued progress towards initiating two new Phase I/II clinical studies for AMT-260 in refractory temporal lobe epilepsy and AMT-162 in SOD1-ALS ~ LEXINGTON, Mass and AMSTERDAM, the Netherlands, May 09, 2023 (GLOBE NEWSWIRE) --  uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the first quarter of 2023 and highlighted recent progress across its business.

uniQure Announces First Quarter 2023 Financial Results and Highlights Recent Company Progress

LEXINGTON, Mass. and AMSTERDAM, May 02, 2023 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that 12 data presentations, including two oral presentations, will be delivered at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting being held May 16-20 in Los Angeles, California.

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

LEXINGTON, Mass. and AMSTERDAM, the Netherlands, March 02, 2023 (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 investor and scientific conferences:

uniQure to Participate in Multiple Upcoming Industry Conferences in March

uniQure (QURE) delivered earnings and revenue surprises of 128.85% and 85.55%, respectively, for the quarter ended December 2022. Do the numbers hold clues to what lies ahead for the stock?

UniQure (QURE) Tops Q4 Earnings and Revenue Estimates

~ Achieved U.S. and European Commission marketing approvals of first and only gene therapy for adults with hemophilia B ~

uniQure Announces 2022 Financial Results and Highlights Recent Company Progress

~ Data follow the historic approval of the first gene therapy for hemophilia B, which has been shown in clinical trials to reduce the rate of annual bleeds, reduce or eliminate the need for prophylactic therapy and generate elevated and sustained factor IX levels for years after a one-time infusion ~

uniQure Announces HOPE-B Clinical Trial Data Published in the New England Journal of Medicine, Demonstrating Durability and Other Benefits of HEMGENIX® (etranacogene dezaparvovec-drlb)

Data follow the historic approval of the first gene therapy for hemophilia B, which reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX levels for years after a one-time infusion 18-month data support the efficacy and safety of HEMGENIX® and the ongoing benefit of this treatment HEMGENIX® is approved for adults with hemophilia B in the United States, European Union and European Economic Area KING OF PRUSSIA, Penn. , Feb. 23, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL) today announced the publication in the New England Journal of Medicine (NEJM) (Vol.

CSL's HOPE-B Data Published in the New England Journal of Medicine, Demonstrating Efficacy and Durability of HEMGENIX® (etranacogene dezaparvovec-drlb)

~ Historic approval represents the first gene therapy in Europe to treat hemophilia B and provides a new treatment option for patients that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy, and generates elevated and sustained factor IX levels ~

uniQure announces the European Commission approval of the first gene therapy for adults with hemophilia B

HEMGENIX® underscores CSL's promise to deliver life-changing innovations that have the potential to help patients lead full lives MARBURG, Germany , Feb. 20, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL) today announced that the European Commission has granted conditional marketing authorization (CMA) for HEMGENIX® (etranacogene dezaparvovec), the first and only one-time gene therapy for the treatment of severe and moderately severe hemophilia B (congenital Factor IX deficiency) in adults without a history of Factor IX inhibitors. In the ongoing clinical trial, HEMGENIX® reduced the rate of annual bleeds with a single infusion by delivering a functional gene that acts as a blueprint for coagulation Factor IX, a protein important for blood clotting.1 It is the first approved gene therapy for hemophilia B in the European Union (EU) and European Economic Area (EEA).

First Gene Therapy for Hemophilia B, CSL's HEMGENIX®, Approved by the European Commission

Hemgenix was approved by FDA. uniQure appears undervalued based on the value of milestones and royalties due to the company.

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