$QURE News
Last published 1d ago
- 1d agoQURESTIFEL 2026 HEALTHCARE CONFERENCE - UNIQURE NVEarnings Call TranscriptsAwesome. We can go ahead and get started. Thanks, everybody, for coming. Very pleased to be here with Matt Capista from Unicure. You know, very topical time to be meeting with the team. Matt, we'll just kick it over to y
- 2d agoQUREGUGGENHEIM 3RD ANNUAL HEALTHCARE INNOVATION CONFERENCE - UNIQURE NVEarnings Call TranscriptsWell, good morning, and thank you for joining Guggenheim's third annual Healthcare Innovations Conference. I am Devjit, one of the therapeutic analysts, and my privilege to welcome Matt Kapusta, the CEO of Unicure. Thank
- 1w agoQUREuniQure N.V. - EXHIBIT 99.1Earnings ReleasesForm 8-K - Current report - Item 2.02 Item 9.01
- 1w agoQUREuniQure Announces FDA Acceptance and Priority Review of the Biologics License Application for ifezuntirgene inilparvovec for the Treatment of Huntington’s DiseaseGlobeNewswire~ FDA sets PDUFA target action date of May 1, 2027 ~ ~ If approved, ifezuntirgene inilparvovec will be the world’s first disease-modifying treatment for Huntington’s disease ~ LEXINGTON, Mass. and AMSTERDAM, Nov. 02,
- 2w agoQUREuniQure to Announce Third Quarter 2026 Financial ResultsGlobeNewswireLEXINGTON, Mass. and AMSTERDAM, Oct. 28, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs will report third
- 1mo agoQUREPhase I/II Ifezuntirgene Inilparvovec (AMT-130) Huntington’s Disease Program Update - UNIQURE NVEarnings Call TranscriptsGood morning and thank you for standing by. My name is Jeanne and I will be your conference operator today. At this time I would like to welcome everyone to the Unicure phase 1 to AMT 130 Huntington's disease program upd
- 2mo agoQUREuniQure Announces Submission of Biologics License Application for Ifezuntirgene Inilparvovec (AMT-130) in Huntington’s DiseaseGlobeNewswire~ Company also announces the submission of a Marketing Authorisation Application for ifezuntirgene inilparvovec in the U.K. ~ ~ Both submissions are supported by the three-year data analysis from the Phase I/II study,
- 3mo agoQUREUNIQURE SECOND QUARTER 2026 EARNINGS CALL - UNIQURE NVEarnings Call TranscriptsHello, and thank you for standing by. My name is Joy, and I will be your conference operator today. At this time, I would like to welcome everyone to the Unicure second quarter 2026 earnings call. All lines have been pla
- 3mo agoQUREuniQure Announces Second Quarter 2026 Financial Results and Provides Company UpdateGlobeNewswire~ U.S. and U.K. regulatory submissions for AMT-130 for Huntington’s disease on track as planned for the third quarter of 2026 ~ ~ Topline four-year data from the Phase I/II study of AMT-130 expected in September 2026 ~
- 3mo agoQUREuniQure to Announce Second Quarter 2026 Financial ResultsGlobeNewswireLEXINGTON, Mass. and AMSTERDAM, July 22, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs will report second
- 4mo agoQUREuniQure Announces Pricing of Upsized $225 Million Public OfferingGlobeNewswireLEXINGTON, Mass. and AMSTERDAM, June 23, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced
- 4mo agoQUREuniQure Announces $150 Million Proposed Public OfferingGlobeNewswireLEXINGTON, Mass. and AMSTERDAM, June 22, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced
- 4mo agoQUREuniQure Announces Preliminary Data on the First Cohort in the Phase I/IIa Clinical Trial of AMT-260 in Refractory Mesial Temporal Lobe EpilepsyGlobeNewswire~ AMT-260 was generally well-tolerated with no serious adverse events observed to date, with early biological signals of potential therapeutic activity ~ LEXINGTON, Mass. and AMSTERDAM, June 19, 2026 (GLOBE NEWSWIRE)
- 4mo agoQUREREPLUniQure to seek FDA approval for Huntington's disease gene therapy after previous clash with agencyCNBCThe announcement comes months after UniQure became embroiled in a public debate with FDA leaders over the clinical trial data supporting its application.
- 4mo agoCLPTICCMNTHIQUREBiotech's New Frontier: Companies Breaking Through Medicine's Toughest BarriersGlobeNewswireDENVER, June 17, 2026 (GLOBE NEWSWIRE) -- (247marketnews.com) – The biotechnology space is delivering a steady stream of potentially market-moving developments this week as companies across oncology, neuroscience, gene
- 4mo agoQUREuniQure Announces Plan for BLA Submission for AMT-130 in Huntington's DiseaseGlobeNewswire~ 3-year analysis from the Phase I/II study can serve as the primary basis of a Biologics License Application for accelerated approval with FDA ~ ~ Company intends to submit the BLA in third quarter of 2026 ~
- 6mo agoQUREUNIQURE 1Q 2026 EARNINGS CALL - uniQureEarnings Call TranscriptsThank you for standing by. My name is Liz and I'll be your conference operator today. At this time, I would like to welcome everyone to the Unicure First Quarter 2026 Earnings Call. All lines have been placed on mute to
- 6mo agoQUREuniQure Announces First Quarter 2026 Financial Results and Provides Recent Company UpdatesGlobeNewswire~ Advancing FDA interactions on AMT-130 for Huntington's disease; Type B meeting scheduled for the second quarter of 2026 ~ ~ Progressing AMT-130 toward expected UK regulatory submission; MAA on track for third quarter
- 6mo agoQUREuniQure Announces Successful UK MHRA Pre-Submission Meeting for AMT-130 in Huntington's DiseaseGlobeNewswire~ Submission of a UK Marketing Authorization Application for AMT-130 is expected in the third quarter of 2026 ~ ~ Type B Meeting with U.S. FDA granted in second quarter; expect to discuss potential Phase III design and
- 6mo agoQUREuniQure to Announce First Quarter 2026 Financial ResultsGlobeNewswire~ uniQure to host earnings call on Tuesday, May 5, 2026 at 8:30 a.m. ET ~ LEXINGTON, Mass. and AMSTERDAM, April 28, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing
- 8mo agoQUREuniQure N.V. Sued for Securities Law Violations - Investors Should Contact The Gross Law Firm Before April 13, 2026 to Discuss Your Rights - QUREPR NewswireThe Gross Law Firm issues the following notice to shareholders of uniQure N.V. (NASDAQ: QURE). Shareholders who purchased shares of QURE during the...
- 8mo agoQUREuniQure N.V. Sued for Securities Law Violations – Investors Should Contact The Gross Law Firm Before April 13, 2026 to Discuss Your Rights – QUREGlobeNewswireNEW YORK, March 06, 2026 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of uniQure N.V. (NASDAQ:QURE). Shareholders who purchased shares of QURE during the class period listed are
- 8mo agoWVEDNLIMRNAGMTX+6FDA reversals leave investors worrying about the fates of other experimental drugsCNBCInvestors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S. Food and Drug Administration.
- 8mo agoUQ1-FFQUREFDA official calls UniQure's gene therapy a 'failed' treatment for Huntington's diseaseCNBCUniQure needs to run another trial to prove its gene therapy "actually helps people with Huntington's disease," said a senior FDA official.
- 8mo agoQURE$QURE ALERT: uniQure N.V. Sued for Securities Law Violations; Block & Leviton Encourages Investors Who Have Lost Money to Contact the FirmGlobeNewswireBOSTON, March 02, 2026 (GLOBE NEWSWIRE) -- Block & Leviton announces that a securities fraud lawsuit has been filed against uniQure N.V. (NASDAQ:QURE) and certain of its executives. Investors who have lost money in
- 8mo agoQUREuniQure Fourth Quarter and Year-End 2025 Earnings Call - uniQureEarnings Call TranscriptsThank you for standing by. My name is Kate, and I will be your conference operator today. At this time, I would like to welcome everyone to the Unicure fourth quarter and year-end 2025 earnings call. All lines have been
- 8mo agoQUREuniQure Announces 2025 Financial Results and Provides Recent Company UpdatesGlobeNewswire~ Held Type A meeting with FDA to discuss AMT-130 for Huntington's disease; Company evaluating Phase III development considerations and plans to request follow-up Type B meeting in the second quarter of 2026 ~ ~
- 8mo agoQUREuniQure Provides Regulatory Update on AMT-130 for Huntington's DiseaseGlobeNewswireLEXINGTON, Mass. and AMSTERDAM, March 02, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced
- 8mo agoQUREThe Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of April 13, 2026 in uniQure N.V. Lawsuit – QUREGlobeNewswireNEW YORK, Feb. 26, 2026 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of uniQure N.V. (NASDAQ:QURE). Shareholders who purchased shares of QURE during the class period listed are
- 8mo agoQUREQURE INVESTOR REMINDER: uniQure N.V. Investors Have Until April 13, 2026 To Seek Lead Plaintiff RoleBusiness WireIf you have suffered a loss on your uniQure N.V. ("uniQure" or the "Company") (NASDAQ:QURE) investment, contact Lauren Molinaro of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the contact form
- 8mo agoQUREuniQure to Announce 2025 Financial ResultsGlobeNewswireLEXINGTON, Mass. and AMSTERDAM, Feb. 23, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs will report fourth
- 8mo agoQUREThe Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of April 13, 2026 in uniQure Lawsuit - QUREPR NewswireThe Gross Law Firm issues the following notice to shareholders of uniQure N.V. (NASDAQ: QURE). Shareholders who purchased shares of QURE during the...
- 9mo agoQUREuniQure Announces Updated Preliminary AMT-191 Phase I/IIa Data Showing Sustained Increases in α-Gal A Enzyme Activity in Patients with Fabry DiseaseGlobeNewswire~ Supraphysiological expression of α-Gal A activity maintained for over a year in longest treated patient as of data cutoff date ~ ~ Stable Lyso-Gb3 levels maintained post-dosing, regardless of enzyme replacement
- 10mo agoQUREuniQure Announces Type A Meeting Scheduled with FDAGlobeNewswireLEXINGTON, Mass. and AMSTERDAM, Jan. 09, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced a
- 11mo agoQUREData Published in the New England Journal of Medicine Confirm the Long-term Durability and Safety of HEMGENIX® (etranacogene dezaparvovec-drlb) Over Five YearsPR NewswireGlobal biopharma leader CSL (ASX:CSL; USOTC:CSLLY) today announced five-year (60-month) results from the pivotal Phase 3 HOPE-B study, confirming the ...
- 11mo agoQUREuniQure Provides Regulatory Update on AMT-130 for Huntington's DiseaseGlobeNewswireLEXINGTON, Mass. and AMSTERDAM, Dec. 04, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced
- 1y agoQUREuniQURE N.V. Investigation: Investors Encouraged to Contact Kirby McInerney LLPBusiness WireThe law firm of Kirby McInerney LLP reminds investors its investigation on behalf of uniQURE N.V. ("uniQURE" or the "Company") (NASDAQ:QURE) investors concerning the Company's and/or members of its senior management's
- 1y agoQUREUNIQURE THIRD QUARTER 2025 EARNINGS CALL - uniQureEarnings Call TranscriptsGood morning and welcome to Unicure's third quarter 2025 earnings call. All participants are in a listen-only mode. After the speaker's remarks, we will conduct a question-and-answer session. To ask a question at this ti
- 1y agoQUREuniQure Announces Third Quarter 2025 Financial Results and Provides Corporate UpdateGlobeNewswire~ Announced pivotal topline data from Phase I/II study of AMT-130 in Huntington's disease met its primary and key secondary endpoints, demonstrating statistically significant slowing of disease progression at 36 months
- 1y agoQUREuniQure to Announce Third Quarter 2025 Financial ResultsGlobeNewswireLEXINGTON, Mass. and AMSTERDAM, Nov. 06, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs will report third
- 1y agoQUREuniQure N.V. INVESTIGATION: Kirby McInerney LLP Announces Investigation Into Potential Securities Fraud on behalf of Investors (QURE)GlobeNewswireNEW YORK, Nov. 04, 2025 (GLOBE NEWSWIRE) -- The law firm of Kirby McInerney LLP is investigating potential claims against uniQure N.V. ("uniQure" or the "Company") (NASDAQ:QURE). The investigation concerns whether the
- 1y agoQUREuniQure Provides Regulatory Update on AMT-130 for Huntington's DiseaseGlobeNewswireLEXINGTON, Mass. and AMSTERDAM, Nov. 03, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced
- 1y agoQUREuniQure Announces Closing of Upsized Public Offering and Full Exercise by Underwriters of Option to Purchase Additional SharesGlobeNewswireLEXINGTON, Mass. and AMSTERDAM, Sept. 29, 2025 (GLOBE NEWSWIRE) -- uniQure N.V.
- 1y agoQUREuniQure Announces Pricing of Upsized $300 Million Public OfferingGlobeNewswireLEXINGTON, Mass. and AMSTERDAM, Sept. 25, 2025 (GLOBE NEWSWIRE) -- uniQure N.V.
- 1y agoQUREVCYTHUMEDITHealthcare Innovation Accelerates as Four Converging Forces Drive Early Intervention FocusPR NewswireAmerica's aging demographics are creating unprecedented demand for precision healthcare solutions, with population projections showing nearly one in...
- 1y agoQUREuniQure Announces $200 Million Proposed Public OfferingGlobeNewswireLEXINGTON, Mass. and AMSTERDAM, Sept. 24, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced
- 1y agoQURETopline Pivotal Results for AMT-130 in Huntington’s Disease - NotifiedEarnings Call TranscriptsGood day, and welcome to the top-line critical results for AMT-130 in Huntington's disease. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. To ask a question
- 1y agoHTGCQUREuniQure Announces Refinancing of Existing $50 Million Debt and Securing Up to an Additional $125 Million in Non-Dilutive FundingGlobeNewswire~ Term of current $50 million debt outstanding extended from January 2027 to October 2030 ~ ~ Additional $100 million available subject to regulatory and financial milestones ~ ~ Additional $25 million available
- 1y agoQUREuniQure Announces Positive Topline Results from Pivotal Phase I/II Study of AMT-130 in Patients with Huntington's DiseaseGlobeNewswire~ Pivotal study met primary endpoint; high-dose AMT-130 demonstrated statistically significant 75% disease slowing at 36 months as measured by cUHDRS compared to a propensity score-matched external control ~ ~ High-dose
- 1y agoQUREuniQure Announces Initial AMT-191 Phase I/IIa Data Showing Sustained Increases in α-Gal A Enzyme Activity in Patients with Fabry DiseaseGlobeNewswire~ All patients in the first cohort achieved between 27- to 208-fold increases in α-Gal A activity relative to mean normal level ~ ~ All patients in first cohort discontinued enzyme replacement therapy ~ ~ Preliminary