Earnings summaries and quarterly performance for uniQure.
Executive leadership at uniQure.
Board of directors at uniQure.
DM
David Meek
Detailed
Chair of the Board
JK
Jack Kaye
Detailed
Non-Executive Director
JS
Jeremy Springhorn
Detailed
Non-Executive Director
LP
Leonard Post
Detailed
Non-Executive Director
MB
Madhavan Balachandran
Detailed
Non-Executive Director
RJ
Rachelle Jacques
Detailed
Non-Executive Director
RG
Robert Gut
Detailed
Non-Executive Director
Research analysts who have asked questions during uniQure earnings calls.
DC
Debjit Chattopadhyay
Guggenheim Securities
2 questions for QURE
Also covers: BEAM, BOLD, HOOK +5 more
EM
Eliana Merle
UBS
2 questions for QURE
Also covers: ALNY, APLS, ARVN +17 more
Jenny Leigh Gonzalez-Armenta
Leerink Partners
2 questions for QURE
Also covers: WVE
Joseph Thome
TD Cowen
2 questions for QURE
Also covers: ALKS, AMLX, ARDX +12 more
LI
Luca Issi
RBC Capital Markets
2 questions for QURE
Also covers: ADVM, ALLO, ALNY +12 more
Patrick Trucchio
H.C. Wainwright & Co.
2 questions for QURE
Also covers: ALT, ARWR, ATAI +13 more
Paul Matteis
Stifel
2 questions for QURE
Also covers: ABOS, ACAD, ALKS +11 more
Salveen Richter
Goldman Sachs
2 questions for QURE
Also covers: ACAD, AGIO, ALLO +20 more
YZ
Yanan Zhu
Wells Fargo Securities
2 questions for QURE
Also covers: ADAP, AFMD, ARCT +13 more
JS
Joseph Schwartz
Oppenheimer
1 question for QURE
Also covers: ASND, AUPH, BMRN +14 more
Kristen Kluska
Cantor Fitzgerald
1 question for QURE
Also covers: ABEO, ADMA, AQST +24 more
Lydia Erdman
Goldman Sachs
1 question for QURE
Also covers: AGIO, TSHA
RM
Richard Miller
Cantor Fitzgerald
1 question for QURE
Also covers: ADMA, PTCT
SC
Samantha Corwin
William Blair
1 question for QURE
Also covers: ALLO, BEAM, KRYS +3 more
SC
Sami Corwin
William Blair
1 question for QURE
Also covers: ALLO, BEAM, KRYS +5 more
SH
Sushila Hernandez
Van Lanschot Kempen Investment Banking
1 question for QURE
Also covers: PHAR, VRNA
Suzanne van Voorthuizen
Kempen & Co
1 question for QURE
Also covers: ARGX, BNTX, GMAB +3 more
UE
Uy Ear
Mizuho Securities
1 question for QURE
Also covers: ALKS, ARQT, EOLS +6 more
Recent press releases and 8-K filings for QURE.
uniQure Announces Updated Preliminary Phase I/IIa Data for AMT-191 in Fabry Disease
QURE
New Projects/Investments
- uniQure announced updated preliminary Phase I/IIa data for its investigational gene therapy, AMT-191, for Fabry disease, as of a January 8, 2026 data cutoff.
- All 11 patients in the study demonstrated elevated α-galactosidase A (α-Gal A) activity, with dose-dependent increases up to 312.52-fold above mean normal levels, which were durable for over a year in the longest-treated patient.
- Six of 11 patients discontinued enzyme replacement therapy (ERT) while maintaining stable plasma lyso-Gb3 levels post-dosing across all cohorts.
- The therapy showed a manageable safety profile, with no related Serious Adverse Events at the two lower doses; however, two patients at the mid-dose experienced asymptomatic Grade 3 liver enzyme elevations, resulting in a temporary pause in dosing for mid- and high-dose cohorts.
16 hours ago
Qure.ai Receives Grant from Bill & Melinda Gates Foundation
QURE
New Projects/Investments
- Qure.ai has secured a multimillion-dollar grant, approximately $8 million, from the Bill & Melinda Gates Foundation.
- The grant is designated for developing AI-enabled point-of-care ultrasound (POCUS) algorithms for early detection of tuberculosis and pneumonia, aiming to reduce diagnosis times from roughly 14 days to one-to-two days.
- This initiative also includes building a large open-source multimodal database for researchers globally, aligning with WHO lung-health diagnostic pathways.
- Qure.ai's existing AI chest X-ray tools are deployed in over 105 countries and have been cited in WHO TB screening guidelines.
Jan 22, 2026, 10:04 PM
uniQure N.V. Provides Corporate Presentation Update with Positive Clinical Data and Strong Financial Position
QURE
New Projects/Investments
Guidance Update
Debt Issuance
- uniQure N.V. reported a strong financial position with approximately $694.2 million of cash as of September 30, 2025, following a $300 million public offering and $125 million in non-dilutive funding secured in September 2025.
- The company's AMT-130 program for Huntington's disease demonstrated statistically significant slowing of disease progression at 36 months, with the high-dose reducing progression by 75% (cUHDRS) and 60% (TFC) compared to external controls.
- For AMT-130, uniQure N.V. plans to engage with the FDA on an Accelerated Approval pathway and is preparing for potential commercialization in 2026.
- The company is advancing its pipeline, with full enrollment of Cohort 1 for AMT-260 (MTLE) and upcoming additional clinical data presentations for AMT-260 and AMT-191 (Fabry Disease) in 1H 2026 and Q1 2026, respectively.
Jan 13, 2026, 12:05 PM
uniQure Schedules FDA Type A Meeting for Huntington's Disease Gene Therapy
QURE
New Projects/Investments
- uniQure has scheduled an FDA Type A meeting to review the Biologics License Application (BLA) data package for AMT-130, its investigational gene therapy for Huntington’s disease, focusing on an accelerated-approval pathway.
- Investors reacted positively to the news, with shares rising 11% to 17% intraday and roughly doubling over the past year.
- Despite this regulatory progress, uniQure faces financial headwinds, including negative profitability and recent revenue declines, reporting a trailing-12-month revenue of approximately $15.75 million and an operating margin of -1102.1%.
- Type A meetings are crucial for resolving significant regulatory issues and could meaningfully shape AMT-130’s approval timeline and patient access.
Jan 9, 2026, 2:19 PM
uniQure Schedules FDA Type A Meeting for AMT-130 Accelerated Approval
QURE
New Projects/Investments
Guidance Update
- uniQure N.V. (NASDAQ: QURE) has scheduled a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the Biologics License Application (BLA) data package for AMT-130.
- The meeting aims to support the accelerated approval of AMT-130, uniQure's investigational gene therapy for the treatment of Huntington’s disease.
- The company expects to provide a regulatory update after receiving official meeting minutes from the FDA.
Jan 9, 2026, 12:06 PM
uniQure Schedules FDA Meeting for AMT-130 Accelerated Approval
QURE
New Projects/Investments
Regulatory Update
- uniQure N.V. (NASDAQ: QURE) announced a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled.
- The meeting will discuss the Biologics License Application (BLA) data package to support accelerated approval of AMT-130, the company’s investigational gene therapy for Huntington’s disease.
- uniQure's CEO, Matt Kapusta, stated the company looks forward to a constructive discussion with the FDA to work towards a timely resolution regarding an accelerated approval pathway for AMT-130.
- The company expects to provide a regulatory update after receiving official meeting minutes.
Jan 9, 2026, 12:05 PM
uniQure N.V. receives FDA feedback on AMT-130 for Huntington's disease
QURE
New Projects/Investments
Regulatory Update
- uniQure N.V. received final meeting minutes from the FDA on December 4, 2025, following a pre-Biologics License Application (BLA) meeting held on October 29, 2025, for its investigational gene therapy, AMT-130, for Huntington's disease.
- The FDA conveyed that data from the Phase I/II studies of AMT-130 are currently unlikely to provide the primary evidence to support a BLA submission.
- uniQure plans to urgently request a follow-up meeting with the FDA in the first quarter of 2026 to evaluate the feedback.
Dec 4, 2025, 12:06 PM
uniQure Reports Q3 2025 Financials and Provides Updates on Pipeline, Including FDA Feedback on AMT-130
QURE
Earnings
Guidance Update
New Projects/Investments
- uniQure reported Q3 2025 revenue of $3.7 million, an increase from $2.3 million in Q3 2024, and ended the quarter with $649.2 million in cash, cash equivalents, and investment securities, which is expected to fund operations into 2029.
- The company announced positive top-line data for AMT-130 in Huntington's disease, demonstrating a statistically significant 75% slowing of disease progression at three years.
- Despite the positive data, the FDA recently communicated that it no longer agrees the phase I-II data for AMT-130 with an external control may be adequate for a BLA submission, leading to uncertainty regarding the timing of submission. This feedback is a "notable shift" from previous FDA communications.
- In other pipeline updates, AMT-260 for epilepsy showed promising initial data, and AMT-191 for Fabry disease reported encouraging results, with updated data for both expected in the first half of 2026. However, enrollment for AMT-162 in SOD1 ALS was voluntarily paused due to a dose-limiting toxicity.
Nov 10, 2025, 1:30 PM
uniQure N.V. Announces Third Quarter 2025 Financial Results and AMT-130 Regulatory Update
QURE
Earnings
Guidance Update
New Projects/Investments
- uniQure N.V. reported a net loss of $80.5 million for the third quarter of 2025, compared to a net loss of $44.4 million in the same period of 2024, with revenue of $3.7 million.
- As of September 30, 2025, the company held $694.2 million in cash, cash equivalents, and current investment securities, following an upsized public offering that raised $323.7 million in net proceeds in September 2025. The company expects this cash position to fund operations into 2029.
- The company announced positive topline 36-month data from the Phase I/II study for AMT-130 in Huntington's disease, showing a statistically significant 75% slowing of disease progression.
- However, preliminary feedback from an October 2025 pre-Biologics License Application (BLA) meeting indicated that the FDA no longer agrees that the Phase I/II data for AMT-130, compared to an external control, may be adequate to support a BLA submission, introducing uncertainty in the timing of the BLA.
Nov 10, 2025, 12:06 PM
uniQure Announces Q3 2025 Financial Results and AMT-130 Clinical & Regulatory Update
QURE
Earnings
Guidance Update
New Projects/Investments
- uniQure reported a net loss of $80.5 million for the third quarter of 2025, compared to a $44.4 million net loss in the same period of 2024, with revenues increasing to $3.7 million from $2.3 million.
- As of September 30, 2025, the company held $694.2 million in cash, cash equivalents, and current investment securities, following approximately $323.7 million in net proceeds from an upsized public follow-on offering, which is expected to fund operations into 2029.
- Pivotal topline data from the Phase I/II study of AMT-130 in Huntington\u2019s disease met its primary and key secondary endpoints, demonstrating a statistically significant 75% slowing of disease progression at 36 months.
- However, preliminary feedback from the FDA at a recent pre-Biologics License Application (BLA) meeting for AMT-130 indicated a key shift from prior regulatory communications, suggesting that Phase I/II data may no longer be adequate for primary evidence in support of a BLA submission, introducing uncertainty in the timing of the BLA submission.
Nov 10, 2025, 12:05 PM
Quarterly earnings call transcripts for uniQure.
Ask Fintool AI Agent
Get instant answers from SEC filings, earnings calls & more