$QURE News
Last published 1d ago
- 1d 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
- 1y agoQUREuniQure N.V. (QURE) Q2 2025 Earnings Call TranscriptEarnings Call Transcripts