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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. (QURE) received an updated Schedule 13G/A from a group of affiliated Susquehanna entities, reporting aggregate beneficial ownership of 3,339,231 Ordinary Shares of EUR 0.05 par value. This represents 4.8% of the company’s outstanding Ordinary Shares as of June 30, 2026.
The shares are held across G1 Execution Services, LLC, SIG Brokerage, LP, Susquehanna Fundamental Investments, LLC, Susquehanna Portfolio Strategies, LLC and Susquehanna Securities, LLC, which may be deemed a group. The reported holdings include options to buy 2,577,700 shares within Susquehanna Securities, LLC and options held by SIG Brokerage, LP. Each reporting person states it has sole voting and dispositive power over its directly held shares and shared power over all group-held shares, while disclaiming beneficial ownership of shares directly owned by the other reporting persons.
RTW Investments, LP and Roderick Wong, M.D. report beneficial ownership of Ordinary Shares of uniQure N.V. Each reporting person is deemed to beneficially own 3,941,572 Shares, representing 5.7% of the class.
The percentage is based on 63,067,485 Shares outstanding as of May 1, 2026, as reported by the company, plus 5,686,813 Shares issued in a public offering that closed on June 25, 2026. The reporting persons have no sole voting or dispositive power, but share voting and dispositive power over the 3,941,572 Shares, which are directly held by certain RTW funds.
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.
Aberdeen Group plc and its subsidiary abrdn Inc. report updated passive ownership in uniQure N.V. under Amendment No. 4 to Schedule 13G. As of June 30, 2026, they beneficially own 2,848,117 ordinary shares, representing 4.52% of the outstanding ordinary-share class.
The group reports no sole voting or dispositive power over these shares. All 2,848,117 shares are held with shared voting and shared dispositive power, principally through abrdn Inc. on behalf of underlying clients, reflecting ownership of less than 5% of the class.
JPMorgan Chase & Co. has reported beneficial ownership of 4,866,211 Ordinary Shares of uniQure N.V., representing 7.0% of this class of securities. The shares are identified by CUSIP N90064101 and relate to Ordinary Shares with a par value of 0.05.
JPMorgan has sole voting power over 4,598,521 shares and shared voting power over 10 shares. It has sole dispositive power over 4,866,201 shares and shared dispositive power over 10 shares. The position is held through subsidiaries including J.P. Morgan Securities LLC, JPMorgan Chase Bank, National Association, JPMorgan Asset Management (UK) Limited, and J.P. Morgan Investment Management Inc.
uniQure N.V.’s CEO Matthew C. Kapusta exercised stock options and sold shares in a pre-planned trade. On July 2, 2026, he exercised options for 21,082 Ordinary Shares at an exercise price of $19.39 per share and converted them into common equity.
That same day, he sold 21,082 Ordinary Shares in three open-market transactions at reported weighted average prices of $44.43, $45.43, and $45.89, with actual sale prices ranging from $44.10 to $46.10. Following these transactions, he directly owned 519,227 Ordinary Shares. The filing states the trades were executed under a Rule 10b5-1 sales plan adopted on October 5, 2025, indicating they were pre-scheduled.
uniQure N.V. Chief Medical Officer Walid Abi-Saab reported an exercise-and-sell transaction in Ordinary Shares. On June 30, 2026, he sold a total of 30,000 Ordinary Shares in open-market sales at weighted average prices of $46.40 and $46.46 per share, under a pre-arranged Rule 10b5-1 trading plan adopted on September 26, 2025.
On the same date, he exercised stock options to acquire 10,000 Ordinary Shares at a $5.59 exercise price, reducing his option position tied to that grant. Following these transactions, he directly owns 148,235 Ordinary Shares and holds 50,500 stock options expiring on March 1, 2034.
uniQure N.V. director Jack Kaye reported option exercises and share sales. On June 30, 2026, he exercised stock options for a total of 21,167 Ordinary Shares at exercise prices of $20.18 and $37.00, then sold the same number of shares in open-market transactions around $46.43–$46.49 per share. These trades were carried out under a pre-arranged Rule 10b5-1 sales plan adopted on June 16, 2025. After these transactions, he directly owned 25,996 Ordinary Shares.