Welcome to our dedicated page for Uniqure SEC filings (Ticker: QURE), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The uniQure N.V. (QURE) SEC filings page on Stock Titan brings together the company’s regulatory disclosures from the U.S. Securities and Exchange Commission. As a Nasdaq Global Select Market issuer, uniQure files current reports on Form 8‑K, annual reports on Form 10‑K, and quarterly reports on Form 10‑Q that describe its gene therapy business, clinical programs, financial condition, and material agreements. These filings document the company’s work in hemophilia B, Huntington’s disease, refractory temporal lobe epilepsy, ALS, Fabry disease, and other severe conditions.
For uniQure, Form 8‑K filings are particularly important. They include clinical and regulatory updates on AMT‑130 for Huntington’s disease, such as topline Phase I/II data, details of pivotal trial design, and feedback from pre‑Biologics License Application meetings with the U.S. Food and Drug Administration. Other 8‑K reports describe public offerings of ordinary shares and pre‑funded warrants, amendments to senior secured term loan facilities with Hercules Capital, and the establishment of at‑the‑market equity programs. Filings also reference the company’s role in the multi‑year clinical development of a gene therapy for hemophilia B and its licensing arrangements with CSL.
On this page, investors can review uniQure’s SEC documents to understand how it reports results of operations, research and development spending, direct financial obligations, and other events that may affect QURE stock. Stock Titan enhances access to these filings with AI‑powered summaries that highlight key points from lengthy reports, helping readers quickly identify major clinical milestones, regulatory decisions, financing terms, and risk disclosures. Real‑time updates from EDGAR, along with structured access to items such as 8‑K current reports and other registered offerings, support deeper analysis of uniQure’s evolving gene therapy portfolio and capital structure.
uniQure reported a regulatory setback for AMT-130, its investigational gene therapy for Huntington’s disease. Following a pre-BLA meeting, the company believes the FDA currently no longer agrees that data from its Phase I/II studies, analyzed against an external control per prespecified protocols and statistical plans, may be adequate as primary evidence for a BLA.
As a result, the timing of the BLA submission for AMT-130 is now unclear. The update was announced on November 3, 2025 via a press release furnished as an exhibit. The disclosure highlights risks common to early-stage gene therapies, including evolving regulatory views on endpoints and comparators, and the potential need for additional clinical evidence.
uniQure N.V. insider Matthew C. Kapusta completed option exercises and multiple open-market sales under a 10b5-1 plan on September 24, 2025. The filing shows exercises of stock options at $7.53 (51,316 shares) and $6.22 (175,000 shares), producing reported acquisitions of 226,316 ordinary shares that increased his beneficial holdings to 877,770 shares before subsequent sales. The reporting person sold a series of shares the same day in multiple transactions at weighted-average prices reported between $39.20 and $45.30, resulting in a net decline to 651,454 shares beneficially owned after all reported sales. The transactions were made pursuant to a January 28, 2025 Rule 10b5-1 plan, and the Form 4 was signed by an attorney-in-fact on September 26, 2025.
uniQure N.V. (QURE) is conducting a registered offering of 5,789,473 ordinary shares and, in lieu of shares to certain investors, 526,316 pre-funded warrants exercisable at $0.0001 per share. The prospectus supplement cites a Nasdaq last sale price of $52.65 on September 25, 2025. Estimated net proceeds are approximately $281.45 million (or $323.75 million if the underwriters' option is exercised) to fund commercialization readiness, a potential AMT-130 launch, development of other clinical candidates and general corporate purposes. Recent clinical updates include positive 36-month topline Phase I/II results for AMT-130: a statistically significant 75% slowing on cUHDRS (p=0.003) and 60% slowing on TFC (p=0.033) for the high-dose group, supportive biomarker change (CSF NfL -8.2%), and a planned pre-BLA meeting with the FDA ahead of an intended BLA submission in Q1 2026. Other programs: AMT-260 (GenTLE) reported a 92% seizure reduction in an early participant; AMT-191 showed sustained GLA activity in four patients; AMT-162 (SOD1-ALS) enrollment is voluntarily paused after a dose-limiting toxicity in one patient. Separately, Dutch tax authorities informed the company that a 2023 EUR 342 million royalty upfront should be treated as 2023 income for Dutch tax purposes; uniQure estimates a tax liability in the mid single- to low double-digit millions of dollars and will record a current tax liability in the quarter ended September 30, 2025.
Form 144 filed relating to proposed sale of uniQure N.V. (QURE) ordinary shares. The notice reports a proposed sale of 15,000 ordinary shares through Citigroup Global Markets on 09/26/2025 with an aggregate market value of $825,000.00 and total shares outstanding noted as 54,866,930. The shares were acquired and to be sold on 09/26/2025 via a stock option exercise and sale pursuant to a 10b5-1 plan, with payment in cash. The filer also reported a prior sale of 3,000 shares on 09/24/2025 generating $120,119.00 in gross proceeds.
Form 144 notice by uniQure N.V. (QURE) reporting a proposed sale of 3,000 ordinary shares through Citigroup Global Markets on 09/24/2025 with an aggregate market value of $120,000.00. The filing lists total shares outstanding as 54,866,930. The securities were acquired and are to be sold on 09/24/2025 as the result of a stock option exercise and sale pursuant to a Rule 10b5-1 plan, and payment for the acquisition was in cash. The filer indicates no securities sold by the same person in the past three months and includes the standard representation that the person does not possess undisclosed material adverse information.
uniQure N.V. (QURE) reported a Form 144 notification showing the proposed sale of 226,316 ordinary shares by a person associated with the company. The shares are to be sold through Citigroup Global Markets on 09/24/2025 with an aggregate market value of $9,381,750.00. The filing states these shares were acquired on 09/24/2025 via stock option exercise and sale pursuant to a Rule 10b5-1 plan, and payment was made in cash. The issuer has 54,866,930 shares outstanding, so the shares notified represent approximately 0.41% of outstanding stock. The filer indicates no other sales in the prior three months and includes the standard certification that no undisclosed material information is known.
uniQure N.V. is offering up to $200,000,000 of ordinary shares and pre-funded warrants, with ordinary shares listed on Nasdaq under the ticker QURE and a reported last sale price of $47.50 on September 24, 2025. The supplement highlights positive pivotal Phase I/II topline 36-month data for AMT-130 in Huntington's disease: a 75% slowing in disease progression by cUHDRS (p=0.003) and a 60% slowing by TFC (p=0.033) versus a propensity score‑matched external control, and the company plans a pre‑BLA meeting with the FDA and intends to submit a BLA in Q1 2026. Other programs: AMT-260 (MTLE) shows early seizure reduction signal; AMT-191 (Fabry) reports sustained GLA activity in cohort 1; AMT-162 (SOD1-ALS) enrollment is voluntarily paused after a dose‑limiting toxicity in cohort 2 while data are evaluated. The company disclosed a Dutch tax assessment related to a 2023 royalty financing upfront payment and expects a current tax liability in the mid single- to low double-digit millions. Financials show a net tangible book value deficit of $(114) million as of June 30, 2025; proceeds are intended for commercialization readiness, potential AMT-130 launch, development, and general corporate purposes.
uniQure N.V. reported it entered into a material amendment to its loan arrangements with Hercules Capital. The filing states an Amendment No. 3 to the Third Amended and Restated Loan and Security Agreement was executed
The event is listed as both an entry into a material definitive agreement and the creation of a direct financial obligation, and the filing includes the signed exhibit for the amendment. The notice is signed by Jeannette Potts, Chief Legal and Compliance Officer, dated
uniQure reported clinical updates for AMT-130 in an 8-K and furnished a press release (Exhibit 99.1) and an investor webcast. The company said FDA discussions allow cohorts 1 and 2 from the Phase I/II studies to be compared to a propensity score-matched external control from the Enroll-HD natural history dataset under a prespecified statistical analysis plan, which may serve as the primary basis for a BLA submission. The company added two protocols to pool data across the U.S. and EU studies and to prespecify the pivotal comparison versus the Enroll-HD external control. Reported outcomes in the release include a statistically significant 75% slowing of disease progression on a composite UHDRS measure, a 60% slowing on Total Functional Capacity, favorable trends in motor and cognitive secondary endpoints including Symbol Digit Modalities Test, and a mean reduction in cerebrospinal fluid neurofilament light protein. The release announced an investor call and a webcast available for replay for 90 days.
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