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 (NASDAQ: QURE ) stock is on the rise Tuesday after the company provided investors with interim clinical data from a PhaseI/II clinical trials for AMT-130. These clinical trials are evaluating the use of AMT-130 as a treatment for Huntington's Disease.

Why Is uniQure (QURE) Stock Up 51% Today?

~ Achieved statistically significant, dose-dependent, and durable evidence of potential therapeutic benefit; Patients receiving high-dose AMT-130 showed 80% slowing of disease progression in the composite Unified Huntington's Disease Rating Scale (cUHDRS) at 24 months compared to a propensity score-weighted external control ~

uniQure Announces Positive Interim Data Update Demonstrating Slowing of Disease Progression in Phase I/II Trials of AMT-130 for Huntington's Disease

~ Proposed divestiture streamlines uniQure's focus and represents an important milestone in its ongoing effort to significantly reduce operating expenses ~

uniQure Announces Sale of Commercial Manufacturing Facility to Genezen

Strategic acquisition will enable Genezen to deliver late-phase and commercial gene therapy development and manufacturing services to customers around the world. BOSTON and INDIANAPOLIS , July 1, 2024 /PRNewswire/ -- Genezen, a best-in-class gene therapy CDMO, today announced an agreement to acquire uniQure's (Nasdaq: QURE) commercial gene therapy operations in Lexington, MA, bringing a strategic manufacturing facility and a world-class team of employees to the company.

Genezen to Acquire uniQure's Commercial Gene Therapy Manufacturing Operations in Lexington, MA

~ Designation based on 24-month interim Phase I/II clinical data for AMT-130 announced in December 2023 ~ ~ AMT-130 is the first therapeutic candidate to receive RMAT Designation for Huntington's disease ~ ~ Receiving RMAT designation enables increased collaboration with the FDA on regulatory approval planning, in addition to the opportunity for expedited product development ~ LEXINGTON, Mass. and AMSTERDAM, June 03, 2024 (GLOBE NEWSWIRE) -- uniQure N.V.

uniQure Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Investigational Gene Therapy AMT-130 in Huntington's Disease

~ On track to initiate FDA interaction regarding AMT-130 in second quarter of 2024 and provide a clinical update from the Phase I/II trials in mid-2024 ~ ~ Clinical trial initiation for Fabry disease on track to begin in second quarter of 2024, followed by refractory mesial temporal lobe epilepsy and SOD1-ALS in third quarter of 2024 ~ ~ Comprehensive review of operations and options to reduce expenses underway and expected to be completed in mid-2024 ~ LEXINGTON, Mass. and AMSTERDAM, May 07, 2024 (GLOBE NEWSWIRE) -- uniQure N.V.

uniQure Announces First Quarter 2024 Financial Results and Highlights Recent Company Progress

UniQure (QURE) came out with a quarterly loss of $1.53 per share versus the Zacks Consensus Estimate of a loss of $1.54. This compares to earnings of $0.15 per share a year ago.

UniQure (QURE) Reports Q4 Loss, Tops Revenue Estimates

~ Presented promising clinical update from U.S. and European Phase I/II trials of AMT-130 in Huntington's disease; Up to three years of follow-up data to be presented in mid-2024; Regulatory interactions and clarity on potential strategies for clinical development expected in 2024 ~

uniQure Announces 2023 Financial Results and Highlights Recent Company Progress

uniQure is valued here as a pre-revenue company assessing its liquidation value, value of potential cash flows from HEMGENIX sales and estimating the worth of its future R&D efforts. In 2023, uniQure achieved some major milestones – approval for its HEMGENIX treatment in US & EU, sale of its royalty interests in it, encouraging data from Huntington's disease trials. With the value for uniQure close to $33/share, it represents a very attractive bargain, trading at below $6 recently.

uniQure: The Valuation Got More Attractive

~ Patients treated with AMT-130 continue to show evidence of preserved neurological function with potential dose-dependent clinical benefits relative to an inclusion criteria-matched natural history  of the disease ~

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

CSL Ltd

HEMGENIX® is the first and only gene therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia B and to show sustained efficacy and safety at three years post-treatment Long-term data continues to show a one-time infusion of HEMGENIX offers elevated and sustained factor IX activity levels for years and significantly reduces the rate of annual bleeds versus factor IX prophylaxis with a favorable safety profile At three years post-treatment with HEMGENIX, 94% of patients remained free of continuous prophylactic treatment KING OF PRUSSIA, Pa. , Dec. 11, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) today announced the three-year results from the pivotal HOPE-B study confirming continued long-term durability and safety of HEMGENIX® (etranacogene dezaparvovec-drlb) following a one-time infusion in people living with hemophilia B.

CSL Behring's HEMGENIX® (etranacogene dezaparvovec-drlb) Demonstrates at Three Years Post-Treatment Long-Term Durability, Safety and Greater Bleed Protection Versus Prophylactic Treatment in People Living with Hemophilia B

LEXINGTON, Mass. and AMSTERDAM, Dec. 08, 2023 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the grant of inducement equity awards to newly hired employees.

uniQure Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

LEXINGTON, Mass. and AMSTERDAM, Nov. 29, 2023 (GLOBE NEWSWIRE) -- uniQure N.V.

uniQure Announces FDA Clearance of Investigational New Drug Application for AMT-191 Gene Therapy for Fabry Disease

KalVista Pharma

MagnaChip Semiconductor

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The mean of analysts' price targets for uniQure (QURE) points to a 405.4% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Wall Street Analysts Believe uniQure (QURE) Could Rally 405.37%: Here's is How to Trade

~ Announced FDA clearance of Investigational New Drug (IND) application for AMT-260 in  refractory mesial temporal lobe epilepsy ~

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

HEMGENIX®, the first and only FDA-approved gene therapy for adults with hemophilia B, wins for Best Product for Rare/Orphan Diseases KING OF PRUSSIA, Pa. and LEXINGTON, Mass.

CSL and uniQure Win 2023 Prix Galien USA Award

UniQure (QURE) possesses 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) Expected to Beat Earnings Estimates: Should You Buy?

LEXINGTON, Mass. and AMSTERDAM, Oct. 24, 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 European Society of Gene and Cell Therapy (ESGCT) Annual Meeting being held October 24-27 in Brussels, Belgium.

uniQure Announces Major Presence at the European Society of Gene and Cell Therapy (ESGCT) Annual Meeting

uniQure (QURE) gains on plans to discontinue investment in some projects and reduce 20% of its workforce.

uniQure (QURE) Up on Restructuring Plans, Workforce Reduction

uniQure said it is cutting back 28% of its workforce. The company is discontinuing much of its pipeline to focus on more promising therapies.

Why Shares of uniQure Are Up Thursday

Gene therapy-focused biotechnology firm uniQure announced it is slashing more than half of its research and technology projects as part of a strategic reorganization aimed at reducing its operating expenses while advancing a selection of its clinical-stage programs to proof-of-concept.  The company said it will no longer be investing in AMT-210 for the treatment of Parkinson's disease and multiple other undisclosed programs.

uniQure slashes more than half of its research programs to preserve cash

UniQure N.V. QURE, -4.74%, a gene therapy company focused on developing therapies for patients with severe medical needs, said Thursday it's planning a strategic overhaul that will cut 28% of its workforce as it strives to cut costs and advance several clinical-stage programs.

UniQure to cut 28% of workforce and scrap more than half its research projects in strategic overhaul

Dutch gene therapy maker uniQure said on Thursday it would cut about 20% of its total workforce, or about 114 jobs, and end investments in more than half of its research and technology projects to reduce costs.

Gene therapy maker UniQure to cut about 20% of workforce

~ Reduction of 28% of workforce not related to HEMGENIX ® manufacturing obligations; Total cost savings of $180 million to extend cash runway into second quarter of 2027 ~

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