Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
QURE Catalyst Timeline
Dated clinical, regulatory and corporate events for uniQure N.V.
Catalyst Timeline
Dated clinical, regulatory & corporate events for uniQure N.V.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How QURE actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-09-30 | ifezuntirgene inilparvovec (AMT-130) | Phase I/II data readout | Phase 1/2 |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| AMT-191 Small moleculeNCT06270316 | Fabry Disease | Phase 1 | RECRUITING | 20 | Nov 30, 2031 |
Clinical Trial Results
Readouts, endpoints and source filings for every QURE program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| ifezuntirgene inilparvovec BreakthroughFast TrackRMAT | Huntington's disease | Phase 1/2 | 2026-09-29 | 80% slowing of disease progression based on cUHDRS (nominal p=0.005); 67% based on TFC (nominal p=0.011); 44% slowing of disease progression (non-significant p=0.144); 61% slowing of disease progression (nominal p=0.008); 54% on cUHDRS (nominal p=0.041); 68% on TFC (nominal p=0.001)Read More | uniQure Announces Additional Data from Ongoing Phase I/II Studies of ifezuntirgene inilparvovec (AMT-130) in Huntington’s Disease Showing Continued Slowing of Disease ProgressionRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Kapusta Matthew CDirector, Officer (CEO, Managing Director) | Option | 21,082 540,309 held | $19.39 | 07/02/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in QURE
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| Avoro Capital Advisors LLC | 2.8 % (180 %) | 309.88 M | 6.73 M | 12.89% ( 768.18 K) |
QURE Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-10-16 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How QURE ranks across every disease it competes in
QURE News
uniQure Announces Additional Data from Ongoing Phase I/II Studies of ifezuntirgene inilparvovec (AMT-130) in Huntington’s Disease Showing Continued Slowing of Disease Progression
uniQure has announced additional data from its ongoing Phase I/II studies of ifezuntirgene inilparvovec, indicating a meaningful slowing of disease progression in Huntington's disease patients. At 36 months, an 80% slowing was observed in the composite Unified Huntington's Disease Rating Scale (cUHDRS), while 48-month results showed a 44% slowing, albeit non-significant. The treatment continues to be well-tolerated, with manageable safety profiles.
Read more →uniQure Announces Submission of Biologics License Application for Ifezuntirgene Inilparvovec (AMT-130) in Huntington’s Disease
uniQure has submitted a Biologics License Application (BLA) to the FDA and a Marketing Authorisation Application (MAA) to the MHRA for ifezuntirgene inilparvovec, a gene therapy for Huntington's disease. These submissions are backed by three-year data from a Phase I/II study indicating a slowing of disease progression. The company is seeking priority review for the BLA, which could expedite the approval process.
Read more →uniQure Announces Second Quarter 2026 Financial Results and Provides Company Update
uniQure reported its Q2 2026 financial results, highlighting progress on AMT-130 for Huntington's disease with regulatory submissions on track. The company also shared promising early data from AMT-260 for epilepsy and a strengthened financial position following a $259 million offering. However, it faces challenges including an increased net loss and concerns regarding AMT-191's safety profile.
Read more →uniQure to Announce Second Quarter 2026 Financial Results
uniQure N.V. will announce its second quarter 2026 financial results on July 29, 2026, before market open. Following the announcement, management will host a conference call at 8:30 a.m. ET. The event will be available via webcast on the company's website, with a replay accessible for 90 days.
Read more →uniQure Announces Closing of Upsized Public Offering and Full Exercise by Underwriters of Option to Purchase Additional Shares
uniQure N.V. has successfully closed an upsized public offering of 5,686,813 ordinary shares at $45.50 each, raising around $259 million. The offering included additional shares purchased by underwriters. The funds will be used for commercialization readiness and the development of clinical candidates, including AMT-130. This marks a significant step for the company in advancing its gene therapy pipeline.
Read more →uniQure Announces Pricing of Upsized $225 Million Public Offering
uniQure N.V. has priced its public offering of 4,945,055 ordinary shares at $45.50 each, aiming to raise approximately $225 million. The offering is set to close around June 25, 2026, pending customary conditions. The company is recognized for its advancements in gene therapy, particularly for severe medical needs.
Read more →uniQure Announces $150 Million Proposed Public Offering
uniQure N.V. has announced a proposed public offering of $150 million of its ordinary shares, with an additional option for underwriters to purchase $22.5 million more. The offering is subject to market conditions, and there is uncertainty regarding its completion and terms. This move aims to bolster the company's financial resources for advancing its gene therapy pipeline.
Read more →uniQure Announces Preliminary Data on the First Cohort in the Phase I/IIa Clinical Trial of AMT-260 in Refractory Mesial Temporal Lobe Epilepsy
uniQure has announced preliminary data from its Phase I/IIa trial of AMT-260 for refractory mesial temporal lobe epilepsy. The initial results show that three out of six patients experienced significant reductions in seizures, while the remaining patients had variable responses. The treatment was well-tolerated with no serious adverse events reported, supporting further evaluation of AMT-260.
Read more →uniQure Announces Plan for BLA Submission for AMT-130 in Huntington’s Disease
uniQure announced plans to submit a Biologics License Application (BLA) for AMT-130, a gene therapy for Huntington's disease, based on a 3-year analysis from its Phase I/II study. The FDA has indicated this data is acceptable for accelerated approval. The company aims to submit the BLA by Q3 2026 and is aligning on the confirmatory study design with the FDA.
Read more →uniQure Announces First Quarter 2026 Financial Results and Provides Recent Company Updates
uniQure reported its Q1 2026 financial results, highlighting advancements in its gene therapy pipeline, particularly AMT-130 for Huntington's disease and AMT-191 for Fabry disease. The company has scheduled a Type B meeting with the FDA and expects to submit a Marketing Authorization Application in the UK. Despite a strong cash position, the company faces challenges with regulatory feedback and safety concerns in ongoing trials.
Read more →uniQure Announces Successful UK MHRA Pre-Submission Meeting for AMT-130 in Huntington’s Disease
uniQure announced a successful Pre-Submission Meeting with the UK's MHRA regarding AMT-130 for Huntington's disease. The company plans to submit a Marketing Authorization Application in Q3 2026, supported by promising trial data showing a 75% slowing of disease progression. Additionally, a Type B meeting with the U.S. FDA is scheduled to discuss Phase III trial design.
Read more →uniQure to Announce First Quarter 2026 Financial Results
uniQure N.V. will announce its first quarter 2026 financial results on May 5, 2026. The company will host a conference call at 8:30 a.m. ET to discuss these results. The event will be available via webcast, and a replay will be accessible for 90 days. Analysts can join the call by dialing in with a specific conference ID.
Read more →uniQure Announces 2025 Financial Results and Provides Recent Company Updates
uniQure reported its 2025 financial results and highlighted advancements in its gene therapy programs. The company is evaluating Phase III development for AMT-130, which has shown significant efficacy in Huntington's disease. Additionally, AMT-260 and AMT-191 are progressing with promising early data. However, regulatory challenges remain, particularly with the FDA's recommendations for AMT-130.
Read more →uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease
uniQure announced a regulatory update regarding AMT-130, its investigational gene therapy for Huntington's disease. The FDA indicated that the existing Phase I/II data is insufficient for a marketing application and recommended a new randomized study. uniQure plans to continue discussions with the FDA and request a Type B meeting to explore potential study designs.
Read more →uniQure to Announce 2025 Financial Results
uniQure N.V. will announce its fourth quarter and full year 2025 financial results on March 2, 2026. Following the announcement, a conference call will be held at 8:00 a.m. ET, accessible via a live webcast. Analysts can participate in a Q&A session by calling in with a provided conference ID.
Read more →uniQure Announces Updated Preliminary AMT-191 Phase I/IIa Data Showing Sustained Increases in α-Gal A Enzyme Activity in Patients with Fabry Disease
uniQure has released updated preliminary data from its Phase I/IIa trial of AMT-191 for Fabry disease, showing sustained increases in α-Gal A enzyme activity in all patients. Six out of eleven patients have successfully discontinued enzyme replacement therapy. The therapy demonstrated a manageable safety profile, although some patients experienced liver enzyme elevations, leading to a pause in higher dose cohorts for further assessment.
Read more →LEADERSHIP IN GENE THERAPY JANUARY 2026 | 2 Disclaimer This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”
uniQure is reinforcing its position as a leader in gene therapy with a strong financial standing, highlighted by approximately $694.2 million in cash as of September 2025. The company has made progress in clinical trials, including promising data for AMT-130, aimed at treating Huntington's disease, and plans for upcoming data readouts for AMT-260 and AMT-191 in 2026. Engagements with the FDA for Biologics License Application pathways are ongoing, reflecting a focused approach toward commercialization. Although some adverse events were noted, the overall clinical profiles remain encouraging.
Read more →uniQure Announces Type A Meeting Scheduled with FDA
uniQure has announced a Type A meeting with the FDA to discuss the Biologics License Application for AMT-130, a gene therapy aimed at treating Huntington's disease. The company emphasizes the urgent need for effective therapies in this area and is committed to working closely with the FDA. A regulatory update will follow after the meeting.
Read more →Data Published in the New England Journal of Medicine Confirm the Long-term Durability and Safety of HEMGENIX® (etranacogene dezaparvovec-drlb) Over Five Years
The five-year results from the Phase 3 HOPE-B study confirm the long-term durability and safety of HEMGENIX (etranacogene dezaparvovec-drlb) for adults with hemophilia B. Published in the NEJM, the data show sustained therapeutic benefits, including a 94% rate of freedom from prophylaxis treatment and strong factor IX activity levels. HEMGENIX remains the only gene therapy available for this condition.
Read more →uniQure Provides Regulatory Update on AMT-130 for Huntington's Disease
uniQure N.V. has provided an update on its investigational gene therapy AMT-130 for Huntington's disease. Following a meeting with the FDA, the company is advised that data from its Phase I/II studies may not be sufficient for a Biologics License Application. As a response, uniQure plans to request a follow-up meeting with the FDA in early 2026. The company remains committed to collaboration with regulatory authorities and emphasizes the pressing need for effective treatments within the Huntington's disease community.
Read more →