Every 8-K that uniQure N.V. (QURE) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow QURE and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full QURE filings page.
uniQure N.V. reported additional results from ongoing Phase I/II studies of its Huntington’s disease gene therapy candidate, ifezuntirgene inilparvovec (AMT-130). Against propensity score-matched external controls, the 36-month analysis of 15 high-dose patients reported 80% slowing on cUHDRS (nominal p=0.005) and 67% on TFC (nominal p=0.011). At 48 months, 12 high-dose patients showed 44% slowing on cUHDRS (non-significant p=0.144) and 61% on TFC (nominal p=0.008).
At 48 months, updated matched controls had 53% missing data; uniQure said faster-progressing patients were more likely to discontinue and this likely understated the treatment effect. At a June 2026 Type B meeting, the FDA communicated that 36-month data from 12 high-dose patients would be acceptable as the primary basis for a BLA under accelerated approval; the BLA submission preceded and did not include today’s results. Five high-dose participants (17%) had treatment-related serious adverse events of central nervous system inflammation, all resolved.
uniQure N.V. (QURE) reported that it has submitted a Biologics License Application (BLA) to the U.S. FDA seeking accelerated approval of ifezuntirgene inilparvovec (AMT-130), an investigational gene therapy for Huntington’s disease. The company also submitted a Marketing Authorisation Application (MAA) to the U.K. MHRA for the same therapy.
Both applications are supported by a three-year data analysis from a Phase I/II study in which the therapy demonstrated a slowing of disease progression compared with an external Enroll-HD control. uniQure has requested FDA priority review and plans to present a four-year data analysis before the end of the current third quarter. Ifezuntirgene inilparvovec has received FDA Breakthrough Therapy, Regenerative Medicine Advanced Therapy and Fast Track designations.
uniQure N.V. reported second quarter 2026 results and updated progress across its gene therapy pipeline. U.S. and U.K. regulatory submissions for AMT-130 for Huntington’s disease remain on track for the third quarter of 2026, with topline four-year Phase I/II data expected in September 2026. Early data from the first cohort of the Phase I/IIa trial of AMT-260 for refractory mesial temporal lobe epilepsy showed biological signals of therapeutic activity and a favorable safety profile, and work continues on AMT-191 for Fabry disease.
The company strengthened its balance sheet through a $259 million follow-on offering, contributing to cash, cash equivalents and current investment securities of $810.3 million as of June 30, 2026, up from $622.5 million as of December 31, 2025; management expects these resources to fund projected operating expenses into 2030. Second quarter 2026 revenue was $5.8 million, research and development expenses were $34.0 million and selling, general and administrative expenses were $17.4 million. Higher other expenses and unfavorable non‑operating items led to a net loss of $81.1 million, or $1.22 per share, compared with a net loss of $37.7 million, or $0.69 per share, a year earlier.
uniQure N.V. has priced an underwritten public offering of 4,945,055 ordinary shares at $45.50 per share, for expected gross proceeds of about $225 million. Underwriters exercised a 30-day option in full to buy an additional 741,758 shares at the same public price, less underwriting discounts and commissions.
The company estimates net proceeds from the offering of approximately $242.7 million after fees and expenses. The shares are being issued under an automatically effective Form S-3ASR shelf registration, with closing expected on or about June 25, 2026, subject to customary conditions.
uniQure N.V. reported preliminary six-month data from the first, low-dose cohort in its Phase I/IIa trial of AMT-260 for refractory mesial temporal lobe epilepsy. Three of six patients showed meaningful reductions in disabling seizures between months four and six, with declines of 79% to 100% from baseline.
The other three patients had mixed results, ranging from a 33% decrease to a 36% increase in disabling seizures over the same period. AMT-260 was generally well-tolerated, with no serious adverse events related to the therapy or surgery, only mild to moderate side effects such as headache, and no need for immunosuppression.
uniQure N.V. reported that the U.S. FDA has indicated the 3-year analysis from its Phase I/II study of AMT-130 in Huntington’s disease can serve as the primary basis of a Biologics License Application for accelerated approval. Based on this feedback, the company plans to submit a BLA for AMT-130 in the third quarter of 2026, targeting patients with early manifest Huntington’s disease.
Before submission, uniQure and FDA aim to align on the design of a required confirmatory study, potentially using a concurrent standard-of-care control instead of a sham procedure. AMT-130 already holds RMAT, Breakthrough Therapy and Fast Track designations, underscoring regulatory focus on a serious disease with no approved disease-modifying therapies.
uniQure N.V. reported results from its 2026 annual meeting, where shareholders approved all proposals on the agenda. They adopted an amendment to the 2014 Share Incentive Plan to increase the number of ordinary shares reserved for equity compensation, following prior approval by the board.
Shareholders also approved amendments to the Articles of Association to reflect the Dutch large company regime, increase authorized share capital and ordinary shares, and add a U.S. federal court exclusive‑forum provision for certain disputes. All director reappointments, share issuance and repurchase authorities, auditor appointment, and advisory executive compensation votes received strong support based on the reported tallies.
uniQure N.V. reported first quarter 2026 results showing a net loss of $53.5 million, or $0.85 per share, compared with a $43.6 million loss a year earlier. Revenue rose to $3.6 million from $1.6 million, mainly from higher license revenue.
The company ended March 31, 2026 with $586.6 million in cash, cash equivalents and current investment securities and expects this to fund operations into the second half of 2029. Research and development expenses fell to $29.2 million, while selling, general and administrative expenses increased to $20.1 million, reflecting hiring for AMT-130 commercial planning.
uniQure highlighted pipeline progress, including ongoing FDA interactions for AMT-130 in Huntington’s disease with a Type B meeting planned in the second quarter of 2026 and a targeted UK marketing authorization application submission in the third quarter of 2026. Additional 2026 updates are expected from AMT-260 in mesial temporal lobe epilepsy, AMT-191 in Fabry disease and AMT-162 in SOD1 ALS.
uniQure N.V. announced a successful pre-submission meeting with the UK Medicines and Healthcare products Regulatory Agency for AMT-130, its investigational gene therapy for Huntington’s disease. The company plans to submit a UK Marketing Authorization Application in the third quarter of 2026.
The planned submission will be based on three-year data from ongoing U.S. and European Phase I/II trials, where high-dose AMT-130 showed a statistically significant 75% slowing of disease progression on a composite Huntington’s scale versus a matched external control (p=.003) and was generally well-tolerated with a manageable safety profile.
uniQure has also been granted a Type B meeting with the U.S. Food and Drug Administration in the second quarter of 2026 to discuss a potential Phase III trial design and the statistical analysis plan for a four-year data readout expected in the third quarter of 2026, while pursuing additional ex-US regulatory pathways.
uniQure N.V. reported 2025 results and a key regulatory update on its Huntington’s disease program AMT-130. The company ended December 31, 2025 with $622.5 million in cash, cash equivalents and current investment securities, up from $367.5 million a year earlier, largely after raising about $404.2 million through public offerings of ordinary shares and pre-funded warrants.
Full-year 2025 revenue was $16.1 million, down from $27.1 million in 2024, mainly due to lower collaboration and contract manufacturing revenue, partly offset by higher license revenue. The net loss narrowed to $199.0 million, or $3.46 per share, compared with a $239.6 million loss, or $4.92 per share, in 2024. Shareholders’ equity improved to $198.9 million from a deficit of $6.8 million. Management expects the year-end cash position to fund operations into the second half of 2029.
On AMT-130, the U.S. FDA told uniQure that Phase I/II data using an external control are not sufficient as primary evidence of effectiveness to support a marketing application and strongly recommended a prospective, randomized, double-blind, sham surgery-controlled study. uniQure plans to seek a Type B FDA meeting in the second quarter of 2026 to discuss Phase III design. The company also highlighted progress in other gene therapy programs, including AMT-260 for refractory mesial temporal lobe epilepsy and AMT-191 for Fabry disease, and completed enrollment of the first AMT-260 Phase I/IIa cohort.
uniQure N.V. filed a Form 8-K to share that it has updated its corporate presentation for investors and other stakeholders. The company is providing the new presentation as Exhibit 99.1 under a Regulation FD disclosure, meaning it is being broadly shared to keep the market informed. The presentation is also available on uniQure’s investor relations website, although the website itself and its contents are not part of this report. The company states that the information in this item and Exhibit 99.1 is being furnished, not filed, so it is not subject to certain Exchange Act liabilities and will only be incorporated into other securities filings if specifically referenced.
uniQure N.V. filed a current report describing a communication milestone with U.S. regulators. On January 9, 2026, the company announced via press release that a Type A meeting with the U.S. Food and Drug Administration has been scheduled. This type of meeting is typically used to discuss important regulatory issues for a product or development program. The press release with further details is included as Exhibit 99.1 and is treated as information that is furnished, not filed, under securities law.
uniQure N.V. (QURE) furnished a press release announcing financial results for the quarter ended September 30, 2025 and provided a corporate update. The release is included as Exhibit 99.1 to a Form 8-K dated November 10, 2025.
The company states the information furnished under Item 2.02, including Exhibit 99.1, is not deemed “filed” under the Exchange Act. uniQure’s ordinary shares trade on the Nasdaq Global Select Market under the symbol QURE.
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. entered into an underwriting agreement for an upsized public equity offering, selling 5,789,473 ordinary shares at $47.50 per share and issuing pre-funded warrants to purchase up to 526,316 additional ordinary shares. The underwriters exercised in full a 30-day option to buy up to 947,368 additional ordinary shares at the public offering price less underwriting discounts and commissions.
The company expects to receive approximately $323.75 million in net proceeds after underwriting discounts and estimated expenses. The pre-funded warrants are exercisable at any time after issuance but include beneficial ownership limits of 4.99% or 9.99%, adjustable up to 19.99% with 61 days’ prior notice. The securities are being offered under an automatically effective shelf registration, with closing expected on or about September 29, 2025 subject to customary conditions.
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 September 22, 2025 by uniQure biopharma, B.V., uniQure, Inc., uniQure IP B.V., the company and Hercules Capital, Inc.
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 September 24, 2025.
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.
uniQure N.V. (QURE) announced an at-the-market (ATM) equity offering program via Form 8-K. Under a new Sales Agreement dated 29 Jul 2025, Leerink Partners LLC will act as sales agent to place up to $200 million of ordinary shares (€0.05 par value) from time to time. Sales may occur on Nasdaq, other U.S. trading venues or through negotiated transactions, and will be executed on a “commercially reasonable efforts” basis.
Key terms:
- Commission: up to 3.0% of gross proceeds to Leerink Partners.
- No obligation: uniQure can choose whether, when and how much stock to sell; the agreement terminates after all shares are sold or upon earlier termination by the parties.
- Registration: shares will be issued under the company’s effective shelf registration statement (Form S-3ASR, File No. 333-284168).
- Legal opinions & exhibits: Sales Agreement (Ex. 1.1), legal opinion (Ex. 5.1) and related consents filed.
The facility enhances capital-raising flexibility but may dilute existing shareholders if fully utilized. No immediate share issuance or financial impact is disclosed.