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uniQure N.V.

QURE
Richly ValuedBiotech · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$22.54
▼ -0.6 · -2.59%

Financials

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R&D Expenses
Operating CF
Total Assets
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Quarterly Cash
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52W LOW $8.7352W HIGH $71.50
Volume
1.82 M
Value Traded
50.78 M
Short % Float
15.39%
-3.92%Week
-51%1 Month
-47.13%3 Month
+46.55%6 Month
-30.15%5 Year
+42.29%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
  • Dilution Risk
  • SEC Filing

Key Stats

Market Cap
1.56 B
EPS (TTM)
-3.64
P/E Ratio
-
Ent. Value
803.33 M
Total Shares
69.33 M
Float Shares
64.46 M
Insiders
7.08%
Institutions
91.97%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Phase 1/2a data readout
AMT-260
refractory mesial temporal lobe epilepsy
Phase 1Gene TherapiesNervous System
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

QURE Catalyst Timeline

Dated clinical, regulatory and corporate events for uniQure N.V.

Catalyst Timeline

Dated clinical, regulatory & corporate events for uniQure N.V.

1198Total events
8Upcoming
227Tier-1 (high impact)
2013 to 2026Coverage

Upcoming catalysts 2

T1Topline Readout
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AMT-260
T2Other Regulator Milestone
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AMT-130

Event history 50

▼Safety Data Updateifezuntirgene inilparvovecFiledClinical Data
Safety update: one suicide in a low-dose patient approximately five years after treatment, assessed as unrelated to treatment
Huntington's diseasesource ↗
▲Topline Readoutifezuntirgene inilparvovecFiledClinical Data
Topline clinical data at 36 and 48 months from ongoing Phase I/II studies of ifezuntirgene inilparvovec
Huntington's diseasesource ↗
▼Primary Endpoint Missedifezuntirgene inilparvovecFiledClinical Data
cUHDRS at 48 months showed 44% slowing but did not reach statistical significance (p=0.144)
Huntington's diseasesource ↗
▲Primary Endpoint Metifezuntirgene inilparvovecFiledClinical Data
TFC showed 61% slowing of disease progression at 48 months (nominal p=0.008)
Huntington's diseasesource ↗
●R&D DayPresentation
uniQure investor conference call and webcast to discuss additional Phase I/II data
●BLA Submissionifezuntirgene inilparvovecFiledRegulatory Filing
BLA submitted to FDA for accelerated approval
Huntington's diseasesource ↗
●EU MAA Submissionifezuntirgene inilparvovecFiledEx-US Regulatory
MAA submitted to UK MHRA
Huntington's diseasesource ↗
●Priority Review Designationifezuntirgene inilparvovecFiledDesignation
Priority review requested for BLA
Huntington's diseasesource ↗
●Quarterly UpdateCorporate
Q2 2026 financial results reported
▲FDA Feedback ReceivedAMT-130FDA Meeting
FDA meeting minutes received confirming alignment on BLA submission
Huntington's diseasesource ↗
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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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 %
2026-09-30ifezuntirgene inilparvovec (AMT-130) Phase I/II data readout Phase 1/2
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D34 / 100
Pipeline Score
$14M
Pipeline Value
Richly Valued
Valuation Signal
2
Drugs Scored
0.0x
rNPV / MCap
Top 57%
Micro Cap
(rank 375 of 658)
Percentile Rank
uniQure N.V. faces pipeline headwinds (34/100), with $34M risk-adjusted pipeline value, led by AMT-191 in Fabry Disease (Phase 1).
Showing 1 of 2 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
AMT-191 Small moleculeNCT06270316Fabry DiseasePhase 1 RECRUITING 20Nov 30, 2031
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Clinical Trial Results

Readouts, endpoints and source filings for every QURE program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
ifezuntirgene inilparvovec
BreakthroughFast TrackRMAT
Huntington's diseasePhase 1/22026-09-2980% 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 MoreuniQure 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
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Kapusta Matthew CDirector, Officer (CEO, Managing Director)Option 21,082 540,309 held$19.39 07/02/2026
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Hedge Fund 13F Activity

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)
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Shares held by hedge funds each quarter, and who bought or sold.

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Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg

Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-10-16
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Real-Time Option Chain

CallsStrikePuts
LastVolOILastVolOI
No data available
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Calls vs Puts by Expiry

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Competitive positioning

How QURE ranks across every disease it competes in

Competitive Position is a premium feature
See how QURE ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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QURE News

QURE
Sep 29, 2026
QUREPhases
▼ -37.3%on this 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 →
QURE
Sep 2, 2026
QUREFDA Updates

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 →
QURE
Jul 29, 2026
QUREFDA Updates
▲ +9.3%on this news· ran to +20% by day 3

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.

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QURE
Jul 22, 2026
QUREConferences/Events

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.

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QURE
Jun 25, 2026
QUREGeneral

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.

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QURE
Jun 24, 2026
QUREGeneral

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.

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QURE
Jun 22, 2026
QUREGeneral
▲ +10.5%on this newsshared move

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.

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QURE
Jun 19, 2026
QUREPhases

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.

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QURE
Jun 17, 2026
QUREFDA Updates
▲ +78.4%on this newsshared move

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.

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QURE
May 5, 2026
QUREFDA Updates

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.

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QURE
Apr 30, 2026
QUREFDA Updates
▲ +19.2%on this newsshared move

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.

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QURE
Apr 28, 2026
QUREConferences/Events

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.

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QURE
Mar 2, 2026
QUREFDA Updates
▼ -32.8%on this newsshared move

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.

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QURE
Mar 2, 2026
QUREFDA Updates
▼ -32.8%on this newsshared move

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.

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QURE
Feb 23, 2026
QUREConferences/Events

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 →
QURE
Feb 6, 2026
QUREPhases

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.

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QURE
Jan 13, 2026
QUREGeneral
▼ -6.7%on this news

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.

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QURE
Jan 9, 2026
QUREFDA Updates
▲ +9.4%on this newsshared move

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.

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QURE
Dec 8, 2025
QUREPhases

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.

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QURE
Dec 4, 2025
QUREFDA Updates
▼ -10.8%on this newsshared move

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.

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About uniQure N.V.

221 employees uniqure.com
HeadquartersPAASHEUVELWEG 25A, AMSTERDAM, 1105 BP
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