Earnings summaries and quarterly performance for uniQure.
Executive leadership at uniQure.
Board of directors at uniQure.
David Meek
Detailed
Chair of the Board
Jack Kaye
Detailed
Non-Executive Director
Jeremy Springhorn
Detailed
Non-Executive Director
Leonard Post
Detailed
Non-Executive Director
Madhavan Balachandran
Detailed
Non-Executive Director
Rachelle Jacques
Detailed
Non-Executive Director
Robert Gut
Detailed
Non-Executive Director
Research analysts who have asked questions during uniQure earnings calls.
Debjit Chattopadhyay
Guggenheim Securities
2 questions for QURE
Also covers: BEAM, BOLD, HOOK +5 more
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
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
Yanan Zhu
Wells Fargo Securities
2 questions for QURE
Also covers: ADAP, AFMD, ARCT +13 more
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
Richard Miller
Cantor Fitzgerald
1 question for QURE
Also covers: ADMA, PTCT
Samantha Corwin
William Blair
1 question for QURE
Also covers: ALLO, BEAM, KRYS +3 more
Sami Corwin
William Blair
1 question for QURE
Also covers: ALLO, BEAM, KRYS +5 more
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
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 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.
3 days ago
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
Bragar Eagel & Squire, P.C. Investigates uniQure N.V. Following Significant Stock Drop
QURE
Legal Proceedings
Profit Warning
- Bragar Eagel & Squire, P.C., a stockholder rights law firm, is investigating potential claims against uniQure N.V. (NASDAQ:QURE) on behalf of its stockholders.
- The investigation concerns whether uniQure violated federal securities laws and/or engaged in unlawful business practices.
- This investigation follows a uniQure press release on November 3, 2025, which disclosed that the FDA no longer agrees that Phase I/II study data for AMT-130 may be adequate for a Biologics License Application (BLA) submission, making the timing of the BLA submission unclear.
- Following this news, uniQure shares experienced a decline of more than 57% in morning trading on the same day.
- Investors who purchased uniQure shares and suffered a loss are encouraged to contact the firm to discuss their options.
Nov 5, 2025, 4:45 PM
UniQure Faces Regulatory Setback for AMT-130, Shares Plummet
QURE
Guidance Update
Product Launch
Demand Weakening
- The FDA informed UniQure that clinical data from its Phase I/II AMT-130 studies are inadequate to support a Biologics License Application (BLA), reversing guidance provided in November 2024.
- This decision leaves the timing of any BLA submission unclear, prompting UniQure to urgently work with regulators to establish a path to approval.
- Following the announcement, UniQure's U.S.-listed shares tumbled approximately 67–68% in premarket trading, erasing much of the stock's significant recent gains.
- UniQure's CEO expressed surprise at the FDA's feedback, calling it a "drastic change" from prior guidance.
Nov 3, 2025, 12:25 PM
uniQure's AMT-130 BLA Submission Timing Unclear After FDA Feedback
QURE
Guidance Update
New Projects/Investments
- uniQure N.V. received unexpected feedback from the U.S. Food and Drug Administration (FDA) during a pre-Biologics License Application (BLA) meeting for its investigational gene therapy, AMT-130, for Huntington's disease on November 3, 2025.
- The FDA no longer agrees that data from the Phase I/II studies of AMT-130, when compared to an external control, may be adequate to provide the primary evidence for a BLA submission. This marks a key shift from prior communications and guidance provided in November 2024.
- As a result, the timing of the BLA submission for AMT-130 is now unclear.
- uniQure plans to urgently interact with the FDA to determine a path forward for accelerated approval and will also engage with regulatory agencies in the European Union and United Kingdom.
Nov 3, 2025, 12:06 PM
uniQure Receives Unexpected FDA Feedback on AMT-130 BLA Submission
QURE
Regulatory Update
New Projects/Investments
Guidance Update
- uniQure received feedback from the U.S. Food and Drug Administration (FDA) during a pre-Biologics License Application (BLA) meeting regarding its investigational gene therapy, AMT-130, for Huntington’s disease.
- The FDA currently no longer agrees that data from Phase I/II studies of AMT-130 compared to an external control may be adequate for a BLA submission, a key shift from prior communications.
- Consequently, the timing of the BLA submission for AMT-130 is now unclear.
- uniQure's CEO stated that this feedback is a drastic change from November 2024 guidance, which indicated that such data could serve as the primary basis for a BLA submission under the Accelerated Approval pathway.
- uniQure plans to urgently interact with the FDA to find a path forward and will also progress discussions with other regulatory agencies.
Nov 3, 2025, 12:05 PM
uniQure Completes Public Offering
QURE
New Projects/Investments
Product Launch
- uniQure N.V. (Nasdaq: QURE) announced the closing of its underwritten public offering on September 29, 2025.
- The offering included 6,736,841 ordinary shares at $47.50 per share, incorporating the full exercise of the underwriters' option, and pre-funded warrants to purchase 526,316 ordinary shares.
- The aggregate gross proceeds to uniQure from the offering were approximately $345 million.
- uniQure intends to use the net proceeds to fund commercialization readiness, the potential commercial launch of AMT-130, development of other clinical product candidates, business development initiatives, research projects, and for general corporate purposes.
Sep 29, 2025, 8:05 PM
uniQure Announces Positive Phase I/II Study Results for AMT-130 in Huntington's Disease
QURE
Product Launch
New Projects/Investments
- High-dose AMT-130 achieved its primary endpoint, demonstrating a statistically significant 75% slowing of disease progression as measured by the Composite Unified Huntington’s Disease Rating Scale (CUHDRS) at 36 months.
- The study also showed a statistically significant 60% slowing of disease progression as measured by Total Functional Capacity (TFC) at 36 months, a key measure for regulatory agencies.
- uniQure plans to submit a Biologics License Application (BLA) for AMT-130 in the first quarter of next year (Q1 2026) with a request for priority review, following a pre-BLA meeting with the FDA in Q4 2025.
- AMT-130 continues to be generally well tolerated, with no new treatment-related serious adverse events observed since December 2022. The company estimates an initial addressable market of approximately 6,000 U.S. Huntington's disease patients at launch.
Sep 24, 2025, 12:30 PM
Quarterly earnings call transcripts for uniQure.
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