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Uniqure Stock Price, News & Analysis

QURE Nasdaq

Welcome to our dedicated page for Uniqure news (Ticker: QURE), a resource for investors and traders seeking the latest updates and insights on Uniqure stock.

uniQure (QURE) is a leading biotechnology company advancing innovative gene therapies for severe genetic diseases, including hemophilia and Huntington's disease. This dedicated news hub provides investors and stakeholders with timely updates on clinical developments, regulatory milestones, and strategic partnerships.

Access the most comprehensive collection of official press releases, clinical trial progress reports, and financial disclosures directly impacting QURE's trajectory. Our curated feed ensures you never miss critical updates about therapeutic advancements or collaborative ventures with industry leaders like Bristol Myers Squibb.

This resource serves investors seeking material events analysis, researchers tracking gene therapy innovations, and healthcare professionals monitoring treatment breakthroughs. All content is sourced from verified channels to maintain accuracy and compliance with financial reporting standards.

Bookmark this page for streamlined access to uniQure's latest announcements. Check back regularly for real-time updates on one of biotech's most dynamic gene therapy innovators.

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uniQure (NASDAQ: QURE) on Nov. 3, 2025 announced FDA feedback from a pre-BLA meeting for AMT-130, its investigational gene therapy for Huntington’s disease.

uniQure said the FDA now appears to disagree that Phase I/II data versus an external control—as prespecified—may be adequate as primary evidence for a BLA, a material shift from prior Type B meeting guidance. As a result, the BLA timing is now unclear. uniQure expects final meeting minutes within 30 days and plans urgent interactions with the FDA while also engaging regulators in the EU and UK. AMT-130 holds Breakthrough Therapy (Apr 2025) and RMAT (May 2024) designations.

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uniQure (NASDAQ:QURE) has successfully closed its upsized public offering, raising approximately $345 million in gross proceeds. The offering included 6,736,841 ordinary shares at $47.50 per share, including 947,368 additional shares from the underwriters' fully exercised option. Additionally, the company issued pre-funded warrants for 526,316 ordinary shares to certain investors.

The proceeds will fund commercialization readiness activities, potential commercial launch of AMT-130, development of clinical product candidates, business development initiatives, and general corporate purposes. The offering was managed by Leerink Partners, Stifel, Guggenheim Securities, and Van Lanschot Kempen as bookrunners, with H.C. Wainwright & Co. as lead manager.

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uniQure (NASDAQ:QURE) has priced its upsized public offering of 5,789,473 ordinary shares at $47.50 per share, along with pre-funded warrants to purchase 526,316 ordinary shares. The offering is expected to generate approximately $300 million in gross proceeds before deducting underwriting costs and expenses.

The company has granted underwriters a 30-day option to purchase up to 947,368 additional ordinary shares. The offering is anticipated to close around September 29, 2025. Leerink Partners, Stifel, Guggenheim Securities, and Van Lanschot Kempen are serving as bookrunning managers, while H.C. Wainwright & Co. is acting as lead manager for the offering.

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uniQure (NASDAQ: QURE), a gene therapy company, has announced a proposed $200 million public offering of ordinary shares and pre-funded warrants. The company will grant underwriters a 30-day option to purchase additional shares up to 15% of the total offering.

The offering will be managed by Leerink Partners, Stifel, Van Lanschot Kempen, and Guggenheim Securities as bookrunning managers. The securities will be offered through uniQure's automatically effective shelf registration statement, with a preliminary prospectus supplement and accompanying prospectus to be filed with the SEC.

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uniQure (NASDAQ: QURE) has secured a $175 million non-dilutive senior secured term loan facility with Hercules Capital. The deal includes refinancing of existing $50 million debt with extended maturity from 2027 to 2030, plus access to $125 million in additional funding. The financing features three tranches: $50 million for current debt refinancing, $100 million tied to regulatory and financial milestones, and $25 million subject to Hercules' approval.

The new arrangement offers a more favorable floating interest rate of 9.70% (previously 11.95%) and aims to support the potential commercial launch of AMT-130, uniQure's gene therapy for Huntington's disease, anticipated in 2026.

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uniQure (NASDAQ: QURE) announced breakthrough results from its pivotal Phase I/II study of AMT-130 for Huntington's disease treatment. The study achieved its primary endpoint, demonstrating a statistically significant 75% disease progression slowdown at 36 months using cUHDRS measurements compared to controls.

Key highlights include a 60% slowing in disease progression measured by Total Functional Capacity (TFC), favorable trends across cognitive and motor functions, and an 8.2% mean reduction in CSF neurofilament light protein from baseline. The high-dose AMT-130 showed a manageable safety profile with no new drug-related serious adverse events since December 2022.

The company plans to submit a Biologics License Application (BLA) in Q1 2026, with potential U.S. launch later that year. AMT-130 has received both Breakthrough Therapy and RMAT designations from the FDA.

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uniQure (NASDAQ: QURE) has announced promising initial data from its Phase I/IIa trial of AMT-191, a gene therapy for Fabry disease. The first cohort of four patients demonstrated remarkable results, with α-Gal A enzyme activity increasing 27- to 208-fold above normal levels.

All patients in Cohort A (6x1013 gc/kg) successfully discontinued enzyme replacement therapy (ERT) while maintaining stable plasma lyso-Gb3 levels. The therapy showed a manageable safety profile, though some adverse events were reported. A second cohort with a lower dose (2x1013 gc/kg) has completed enrollment with no serious adverse events reported to date.

The company plans to present updated clinical results in the first half of 2026.

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uniQure (NASDAQ: QURE) reported Q2 2025 financial results and significant progress across its gene therapy pipeline. The company achieved FDA alignment for AMT-130 in Huntington's disease, supporting a planned BLA submission in Q1 2026. Key highlights include a 92% seizure reduction in the first AMT-260 patient for epilepsy treatment and the appointment of Kylie O'Keefe as Chief Customer and Strategy Officer.

Financial results show $377.0 million in cash and investments as of June 30, 2025, expected to fund operations into H2 2027. Q2 revenues were $5.3 million, down from $11.1 million in Q2 2024. Net loss improved to $37.7 million ($0.69 per share) compared to $56.3 million ($1.16 per share) in the same period last year.

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uniQure (NASDAQ: QURE), a leading gene therapy company, will release its second quarter 2025 financial results before market open on Tuesday, July 29, 2025. The company will host a conference call and webcast at 8:30 a.m. ET to discuss the results.

The earnings call will be accessible via webcast through uniQure's website under the Events & Presentations section, with a replay available for 90 days. Phone participants must pre-register online to receive dial-in details and are advised to join 15 minutes before the start time.

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uniQure (NASDAQ: QURE) has appointed Kylie O'Keefe as Chief Customer and Strategy Officer, effective June 6, 2025. O'Keefe will lead the global commercialization strategy for AMT-130, the company's investigational gene therapy for Huntington's disease, with a potential U.S. launch in 2026. She brings extensive experience in rare diseases and gene therapy from her previous role as Chief Commercial Officer at PTC Therapeutics, where she managed global commercial operations across 50+ countries and led launches including Upstaza for AADC deficiency. At uniQure, O'Keefe will oversee commercial functions and medical affairs, leveraging her expertise in reimbursement strategies, payer engagement, and health economic assessments. The appointment strengthens uniQure's leadership team as they prepare to transition into a commercial-stage biotechnology company with AMT-130, which could become the first disease-modifying treatment for Huntington's disease.
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FAQ

What is the current stock price of Uniqure (QURE)?

The current stock price of Uniqure (QURE) is $34.29 as of November 3, 2025.

What is the market cap of Uniqure (QURE)?

The market cap of Uniqure (QURE) is approximately 4.2B.
Uniqure

Nasdaq:QURE

QURE Rankings

QURE Stock Data

4.17B
56.80M
6.08%
96.92%
16.51%
Biotechnology
Pharmaceutical Preparations
Link
Netherlands
AMSTERDAM