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olivLaw · US equity research

uniQure N.V. QURE

Pharmaceutical Preparations · SIC 2834 · Vertical: Pharmaceutical Preparations (SIC 2834)

23.03USD−3.52% · 1 dayClose 04 Nov 2026

uniQure N.V. is a gene therapy company developing single treatments aimed at potentially curative results for rare and devastating diseases, with a focus on Huntington's disease. In July 2026 the FDA agreed that a BLA submission under the accelerated approval pathway is reasonable, and the company expects to submit in the third quarter of 2026, a decisive milestone for its lead program.

The AI analysis may be outdated: new filings came after its sources (see the «AI analysis» section).

At the close of 04 Nov 2026, uniQure N.V. (QURE) stock was 23.03 USD (−3.52% on the day), with market capitalisation 1.6 bn USD, beta 1.03, 52-week range 9.03–51.05 USD. Latest reported quarter (Q3 2026): revenue of 5.2 m USD (+40.4% YoY), net income of -61.2 m USD, diluted EPS -0.88 USD.

Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.

Market cap
1.6 bn USD
shares as of 02 Nov 2026
P/E (TTM)
unavailable
Diluted EPS TTM -3.55 · TTM to 30 Sept 2026
E/P (TTM)
-15.39%
TTM to 30 Sept 2026
Dividend yield
unavailable
Beta (2y)
1.03
Volatility (1y) 127%
52-week range
9.0351.05

Price history

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Technical reading

RSI (14)
38.4
weak (30–45)
Bollinger (20, 2)
20.51 – 25.25
in the upper half of the band · %B 0.53 · band width 20.7%
SMA 50 / 200
33.01 / 29.67
mixed trend
MACD (12, 26, 9)
-2.11 / -2.95
MACD above signal

Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).

Performance

CompanyS&P 500vs S&P 500Vertical median
1 month+1.0%−1.1%+2.1 pp—
3 months−47.9%−0.5%−47.5 pp—
6 months+0.9%+4.4%−3.5 pp—
Year to date−3.8%+12.3%−16.1 pp—
1 year−24.3%+13.5%−37.9 pp+8.9%
3 years+276.6%+76.4%+200.2 pp+15.7%
5 years−34.6%+63.7%−98.3 pp—
Max drawdown (1y)
−70.7%
11 Nov 2025 → 03 Mar 2026
Max drawdown (5y)
−89.4%
08 Nov 2021 → 08 Jul 2024
Compound annual growth (5y)
−8.2%
S&P 500 +10.4%

Price returns, dividends excluded.

Quarterly results

Latest quarter: Q3 2026 · 30 Sept 2026

Revenue
5.2 m USD
+40.4% YoY
Net income
-61.2 m USD
unavailable YoY
Diluted EPS
-0.88
unavailable YoY
net / operating
-1,178.2% / -1,019.6%

Quarterly margins

Quarterly statements · USD

Fiscal yearQ4 '24Q1 '25Q2 '25Q3 '25Q4 '25Q1 '26Q2 '26Q3 '26
Revenue5.2 m1.6 m5.3 m3.7 m5.6 m3.6 m5.8 m5.2 m
Cost of revenue619.0 k197.0 k656.0 k398.0 k435.0 k219.0 k350.0 k236.0 k
Research & development38.8 m36.1 m35.4 m34.4 m34.8 m29.2 m34.0 m35.5 m
SG&A11.4 m10.9 m13.5 m19.4 m21.6 m20.1 m17.4 m23.9 m
Operating income-45.8 m-39.3 m-43.9 m-51.0 m-51.1 m-45.7 m-52.2 m-53.0 m
Depreciation & amortisation4.4 m4.5 m3.6 m ≈3.6 m ≈3.0 m3.0 m4.9 m ≈5.5 m ≈
Interest expense14.9 m15.1 m15.6 m16.7 m14.6 m14.0 m14.4 m14.6 m
Pre-tax income-72.4 m-43.1 m-37.3 m-71.9 m-41.0 m-53.0 m-79.2 m-60.5 m
Income tax856.0 k496.0 k425.0 k8.6 m-3.9 m488.0 k1.8 m676.0 k
Net income-73.3 m-43.6 m-37.7 m-80.5 m-37.1 m-53.5 m-81.1 m-61.2 m
Diluted EPS-1.50 ≈-0.82-0.69-1.38-0.60 ≈-0.85-1.22-0.88
Operating cash flow-52.8 m-44.1 m-39.9 m ≈-16.4 m ≈-77.6 m-38.2 m-28.6 m ≈-47.8 m ≈
Capex40.0 k126.0 k260.0 k ≈-66.0 k ≈119.0 k140.0 k472.0 k ≈11.0 k ≈

≈ derived quarter (cumulative difference / share-days average)

E/P over time

E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.

Fiscal years

Fiscal year20182019202020212022202320242025
Revenue11.3 m7.3 m37.5 m524.0 m106.5 m15.8 m27.1 m16.1 m
Revenue YoY−13.9%−35.5%+415.2%+1,296.8%−79.7%−85.1%+71.2%−40.6%
Net income-83.3 m-124.2 m-125.0 m329.6 m-126.8 m-308.5 m-239.6 m-199.0 m
Net income YoYunavailableunavailableunavailableunavailable−138.5%unavailableunavailableunavailable
Diluted EPSunavailable-3.11-2.817.04-2.71-6.47-4.92-3.46
Diluted EPS YoYunavailableunavailableunavailableunavailable−138.5%unavailableunavailableunavailable
net %-738.2%-1,705.8%-333.3%62.9%-119.1%-1,947.1%-883.4%-1,236.0%
Free cash flow-78.4 m-104.3 m-142.1 m270.5 m-162.7 m-153.1 m-186.1 m-178.4 m

Reported results vs expectations

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Balance sheet & financial health

Fiscal year 2025 · 31 Dec 2025

Cash
80.2 m USD
Financial debt
49.7 m USD
Net debt
-30.5 m USD
Equity
198.9 m USD
Total assets
824.9 m USD
Debt / equity
0.25x
Current ratio
10.43x
ROE
unavailable
ROA
-28.8%
FCF margin
-1,108.2%

Financial statements (source on every figure)

Revenue and net income (USD)

Margins

Income statement · USD

Revenue
2023
15.8 m
2024
27.1 m
2025
16.1 m

SEC (XBRL)· 02 Mar 2026verified

Cost of revenue
2023
65.0 k
2024
1.3 m
2025
1.7 m

SEC (XBRL)· 02 Mar 2026verified

Gross profit
2023
15.8 m ≈
2024
25.9 m ≈
2025
14.4 m ≈

SEC (XBRL)· 02 Mar 2026derived

Research & development
2023
214.9 m
2024
143.8 m
2025
140.7 m

SEC (XBRL)· 02 Mar 2026verified

SG&A
2023
74.6 m
2024
52.7 m
2025
65.5 m

SEC (XBRL)· 02 Mar 2026verified

Operating income
2023
-282.9 m
2024
-184.3 m
2025
-185.3 m

SEC (XBRL)· 02 Mar 2026verified

Depreciation & amortisation
2023
11.9 m
2024
12.6 m
2025
14.8 m

SEC (XBRL)· 02 Mar 2026verified

EBITDA
2023
-271.0 m ≈
2024
-171.7 m ≈
2025
-170.6 m ≈

SEC (XBRL)· 02 Mar 2026derived

Interest expense
2023
41.6 m
2024
63.7 m
2025
62.0 m

SEC (XBRL)· 02 Mar 2026verified

Pre-tax income
2023
-306.6 m
2024
-237.1 m
2025
-193.3 m

SEC (XBRL)· 02 Mar 2026verified

Income tax
2023
1.9 m
2024
2.4 m
2025
5.6 m

SEC (XBRL)· 02 Mar 2026verified

Net income
2023
-308.5 m
2024
-239.6 m
2025
-199.0 m

SEC (XBRL)· 02 Mar 2026verified

Diluted EPS
2023
-6.47
2024
-4.92
2025
-3.46

SEC (XBRL)· 02 Mar 2026verified

Weighted average diluted shares
2023
47.7 m
2024
48.6 m
2025
57.5 m

SEC (XBRL)· 02 Mar 2026verified

Balance sheet · USD

Cash
2023
241.4 m
2024
158.9 m
2025
80.2 m

SEC (XBRL)· 02 Mar 2026verified

Receivables
2023
—
2024
—
2025
5.9 m

SEC (XBRL)· 05 May 2026verified

Inventories
2023
12.0 m
2024
—
2025
—

SEC (XBRL)· 28 Feb 2024verified

Current assets
2023
651.9 m
2024
390.3 m
2025
656.0 m

SEC (XBRL)· 02 Mar 2026verified

Property, plant & equipment, net
2023
46.5 m
2024
20.4 m
2025
13.8 m

SEC (XBRL)· 02 Mar 2026verified

Goodwill
2023
26.4 m
2024
22.4 m
2025
25.4 m

SEC (XBRL)· 02 Mar 2026verified

Intangibles (excl. goodwill)
2023
60.5 m
2024
71.0 m
2025
72.8 m

SEC (XBRL)· 02 Mar 2026verified

Total assets
2023
831.7 m
2024
556.5 m
2025
824.9 m

SEC (XBRL)· 02 Mar 2026verified

Accounts payable
2023
6.6 m
2024
7.2 m
2025
5.2 m

SEC (XBRL)· 02 Mar 2026verified

Long-term debt
2023
101.7 m
2024
51.3 m
2025
49.7 m

SEC (XBRL)· 02 Mar 2026verified

Current liabilities
2023
73.7 m
2024
40.1 m
2025
62.9 m

SEC (XBRL)· 02 Mar 2026verified

Total liabilities
2023
624.0 m
2024
563.3 m
2025
626.0 m

SEC (XBRL)· 02 Mar 2026verified

Equity
2023
207.7 m †
2024
-6.8 m †
2025
198.9 m †

SEC (XBRL)· 02 Mar 2026verified

Cash flow · USD

Operating cash flow
2023
-145.9 m
2024
-182.7 m
2025
-178.0 m

SEC (XBRL)· 02 Mar 2026verified

Capex
2023
7.2 m
2024
3.4 m
2025
439.0 k

SEC (XBRL)· 02 Mar 2026verified

Free cash flow
2023
-153.1 m ≈
2024
-186.1 m ≈
2025
-178.4 m ≈

SEC (XBRL)· 02 Mar 2026derived

Investing cash flow
2023
-205.7 m
2024
163.0 m
2025
-321.6 m

SEC (XBRL)· 02 Mar 2026verified

Financing cash flow
2023
362.7 m
2024
-59.5 m
2025
415.4 m

SEC (XBRL)· 02 Mar 2026verified

Computed indicators

Growth

Revenue growth (YoY)
-40.6%
computed by olivLawFY 2025
Revenue CAGR 3Y
-46.7%
computed by olivLawFY 2022 → FY 2025
Revenue CAGR 5Y
-15.6%
computed by olivLawFY 2020 → FY 2025
EBIT growth (YoY)
unavailable
the base of the ratio is not positive
Net income growth (YoY)
unavailable
the base of the ratio is not positive
Net income CAGR 3Y
unavailable
the base of the ratio is not positive
Net income CAGR 5Y
unavailable
the base of the ratio is not positive
EPS growth (YoY)
unavailable
the base of the ratio is not positive
EPS CAGR 3Y
unavailable
the base of the ratio is not positive
EPS CAGR 5Y
unavailable
the base of the ratio is not positive
FCF growth (YoY)
unavailable
the base of the ratio is not positive

Profitability

Gross margin
93.9%
computed by olivLawTTM to 30 Sept 2026
EBITDA margin
-921.0%
computed by olivLawTTM to 30 Sept 2026
EBIT margin
-1,001.7%
computed by olivLawTTM to 30 Sept 2026
Net margin
-1,154.8%
computed by olivLawTTM to 30 Sept 2026
FCF margin
-956.8%
computed by olivLawTTM to 30 Sept 2026

Returns

ROE
-89.0%
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
ROA
-25.5%
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
ROIC
unavailable
insufficient data
ROCE
-22.9%
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
Payout ratio (EPS)
unavailable
input data missing
Payout ratio (FCF)
unavailable
input data missing

Balance sheet

Net debt
-48.1 m USD
computed by olivLawbalance sheet at 30 Sept 2026
Net debt / EBITDA
unavailable
insufficient data
Debt / equity
0.2x
computed by olivLawbalance sheet at 30 Sept 2026
Interest coverage
-3.5x
computed by olivLawTTM to 30 Sept 2026

Liquidity

Current ratio
11.5x
computed by olivLawbalance sheet at 30 Sept 2026
Quick ratio
unavailable
input data missing
Cash ratio
1.6x
computed by olivLawbalance sheet at 30 Sept 2026

Cash

Operating cash flow
-192.2 m USD
computed by olivLawTTM to 30 Sept 2026
Capital expenditure
742.0 k USD
computed by olivLawTTM to 30 Sept 2026
Free cash flow
-193.0 m USD
computed by olivLawTTM to 30 Sept 2026
FCF conversion
unavailable
insufficient data
Cash conversion
unavailable
insufficient data

Efficiency

Days sales outstanding
87 days
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
Days inventory outstanding
unavailable
input data missing
Days payables outstanding
1,825 days
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
Cash conversion cycle
unavailable
input data missing

Market and valuation

Market capitalisation
1.6 bn USD
computed by olivLawbalance sheet at 30 Sept 2026
Enterprise value
1.6 bn USD
computed by olivLawbalance sheet at 30 Sept 2026
Market cap / net income TTM
unavailable
insufficient data
P/E (TTM)
unavailable
insufficient data
Earnings yield
-15.4%
computed by olivLawTTM to 30 Sept 2026
P/B
5.5x
computed by olivLawbalance sheet at 30 Sept 2026
P/S
80.1x
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
EV/EBITDA
unavailable
insufficient data
EV/EBIT
unavailable
insufficient data
EV/Sales
77.7x
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
P/FCF
unavailable
the base of the ratio is not positive
FCF yield
-11.9%
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero
Shareholder yield (distributions)
unavailable
input data missing

1 indicators that do not apply to the sector.

Valuation

olivLaw classification

Insufficient data
What is missing
  • indicators available: 5 of at least 6
  • score weight coverage: 33.3% of at least 60%
  • valuation methods computed: 0 of at least 1

A scoring methodology on indicators and valuation, not investment advice.

Closing price

23.03 USD

04 Nov 2026Source: olivLaw, closing series

Market cap: 1.6 bn USD

Key indicators

Market capitalisation
1.6 bn USD
computed by olivLawbalance sheet at 30 Sept 2026
P/E (TTM)
unavailable
insufficient data
P/B
5.5x
computed by olivLawbalance sheet at 30 Sept 2026
EV/EBITDA
unavailable
insufficient data
ROE
-89.0%
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
Net margin
-1,154.8%
computed by olivLawTTM to 30 Sept 2026
Revenue growth (YoY)
-40.6%
computed by olivLawFY 2025
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero

Coverage and freshness

32/37 reporting lines present
Latest full fiscal year: 2025
Latest reported period: 30 Sept 2026
Latest balance sheet date: 30 Sept 2026
Share count (cover of the latest filing), as of: 02 Nov 2026
Source: SEC (XBRL)published 04 Nov 2026
verified 1475derived 129

Score by group

33% · Insufficient data

Estimated value range

unavailable — no valuation method could be computed

Valuation assumptions are editorial choices, not measured; beta is not measured.

Valuation methods

  • DCF (discounted cash flow)unavailable · the base of the ratio is not positive
  • Peers: EV/EBITDAunavailable · the base of the ratio is not positive
  • Peers: P/Eunavailable · the base of the ratio is not positive
  • Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption

no valuation method could be computed

Multiple comparisons use the SIC vertical: Pharmaceutical Preparations (SIC 2834)

Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.

Assumptions (illustrative, editorial)

Risk-free rate
4.3%
Equity risk premium
5.0%
Beta (default)
1.00
Cost of equity
9.3%
Terminal growth
2.5%

Factor scorecard

Insufficient data

Minimum-evidence gate: indicators available: 5 of at least 6; score weight coverage: 33.3% of at least 60%; valuation methods computed: 0 of at least 1

FactorValueScoreWeight used
ROIC · Qualityunavailableunavailable—
Net margin · Quality-1,154.8%3 (vs peers)19%
FCF conversion · Qualityunavailableunavailable—
Revenue CAGR 3Y · Growth-46.7%0 (on a fixed band)25%
EPS CAGR 3Y · Growthunavailableunavailable—
Net debt / EBITDA · Balance sheetunavailableunavailable—
Interest coverage · Balance sheet-3.5x0 (on a fixed band)19%
Current ratio · Balance sheet11.5x100 (on a fixed band)13%
P/E (TTM) · Valuationunavailableunavailable—
EV/EBITDA · Valuationunavailableunavailable—
FCF yield · Valuation-11.9%0 (on a fixed band)25%
Shareholder yield (distributions) · Returnsunavailableunavailable—
Payout ratio (FCF) · Returnsunavailableunavailable—

Factors without a value were dropped; the remaining weights were renormalised.

Score groups

  • Balance sheet40/100 · 2/3 factors with a value
  • Growth· partial0/100 · 1/2 factors with a value
  • Quality· partial3/100 · 1/3 factors with a value
  • Returns· partialunavailable · 0/2 factors with a value
  • Valuation· partial0/100 · 1/3 factors with a value

A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.

Memo

uniQure N.V. (QURE). Latest full fiscal year: 2025; data up to 2026-09-30.

Figures computed from the financial statements: revenue 16.1 m USD in 2025; YoY growth -40.6%; net margin -1,154.8%; ROE -89.0%.

Valuation cannot be computed from the available data.

Insufficient data for a verdict (indicators available: 5 of at least 6; score weight coverage: 33.3% of at least 60%; valuation methods computed: 0 of at least 1).

Text generated deterministically from the figures shown; no language model. Not investment advice.

What supports the thesis

  • Current ratio: 11.5x

What contradicts it

  • Net margin: -1,154.8%
  • Revenue CAGR 3Y: -46.7%
  • Interest coverage: -3.5x
  • FCF yield: -11.9%

Not assessed (insufficient data or a ratio without meaning): ROIC, FCF conversion, EPS CAGR 3Y, Net debt / EBITDA, P/E (TTM), EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).

Versus the vertical median

Pharmaceutical Preparations (SIC 2834) · same industry (4-digit SIC) · compared with 39 companies

Multiples and returns vs the median

P/E
—
vertical median 38.6x
EV/EBITDA
—
vertical median 20.2x
P/S
80.1x
vertical median 5.5x
above median (+1,355.9%)
P/B
5.5x
vertical median 4.1x
above median (+32.8%)
ROE
-89.0%
vertical median -6.2%
below median
Net margin
-1,154.8%
vertical median 9.7%
below median (−11,947.9%)
EBIT margin
-1,001.7%
vertical median 10.2%
below median (−9,886.3%)
Revenue YoY
-40.6%
vertical median 5.4%
below median (−857.3%)
Net debt/EBITDA
—
vertical median -0.2x
Dividend yield
—
vertical median 2.2%

Price rebased to 100 (monthly, 5 years)

Companies in the vertical

Market capP/EROENet marginRevenue YoY1A / 3A
LLYEli Lilly And Company1,334.0 bn46.086.1%31.9%+44.7%+32% / +140%
JNJJohnson & Johnson665.2 bn41.920.0%16.2%+6.0%+34% / +79%
ONCBeone Medicines Ltd.558.4 bn869.914.7%10.7%+40.2%+11% / +102%
ABBVAbbVie Inc.521.1 bn50.7—15.7%+8.6%+29% / +107%
MRKMerck & Co., Inc.370.7 bn154.75.1%3.6%+1.3%+43% / +47%
ABTAbbott Laboratories200.1 bn43.09.2%9.7%+5.7%−10% / +11%
PFEPfizer Inc175.5 bn43.94.4%6.3%−1.6%+20% / +1%
VRTXVertex Pharmaceuticals Inc139.2 bn35.320.8%30.7%+8.9%+27% / +55%
BMYBristol-Myers Squibb Company131.2 bn14.244.1%18.5%−0.2%+30% / +30%
TEVATeva Pharmaceutical Industries Limited48.8 bn97.46.6%3.6%+4.3%+56% / +326%
ZTSZoetis Inc.36.9 bn14.764.4%27.5%+2.3%−30% / −50%
ROIVRoivant Sciences Ltd.27.6 bn—-6.2%-3,535.0%−71.6%+84% / +300%
RPRXRoyalty Pharma plc26.2 bn47.76.9%25.7%+5.1%+69% / +150%
UTHRUnited Therapeutics Corporation25.9 bn23.019.1%38.6%+10.6%+25% / +154%
INSMInsmed Inc24.1 bn—-72.5%-39.9%+66.7%−47% / +340%
VTRSViatris Inc.22.1 bn—-23.6%-23.9%−3.0%+80% / +109%
ALNYAlnylam Pharmaceuticals, Inc.21.6 bn8.1126.6%52.8%+65.2%−64% / −4%
ORKAOruka Therapeutics, Inc.6.7 bn—-18.2%—unavailable+237% / +364%
HRMYHarmony Biosciences Holdings, Inc.2.0 bn11.418.7%18.1%+21.5%−2% / +18%
QUREuniQure N.V.1.6 bn—-89.0%-1,154.8%−40.6%−24% / +277%
OMEROmeros Corp1.3 bn10.5——−34.0%+88% / +730%
VSTMVerastem, Inc.892.0 m—-471.2%-231.6%+209.1%−7% / +43%
COLLCollegium Pharmaceutical, Inc.770.6 m19.117.6%5.9%+23.6%−49% / −8%
IBOImpact BioMedical, INC.442.1 m560.3371.3%2,254.3%unavailable−27% / unavailable
KMDAKamada Ltd428.0 m21.27.6%11.2%+12.1%+11% / +57%

1- and 3-year price returns: for QURE from daily closes (the same as the performance table), for the other companies from month-end closes.

olivLaw engine forecast

The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.

The engine has no published run for this company yet.

Valuation scenarios (editable assumptions)

Illustrative scenarios

Illustrative: not forecasts and without probabilities. Each case is one coherent set of assumptions, computed on today's figures.

Bear
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Base
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Bull
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Nothing is saved.

Estimated price (USD)

Estimated priceBearBaseBull
1 years
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
3 years
insufficient data
Total return unavailable · Per year unavailable
insufficient data
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What moves the 3-year price the most

    AI analysis

    AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

    Possibly outdated: the newest document it read is from 29 Jul 2026; since then the company filed 8-K (04 Nov 2026 · results), 10-Q (04 Nov 2026).

    In brief

    uniQure N.V. is a gene therapy company developing single treatments aimed at potentially curative results for rare and devastating diseases, with a focus on Huntington's disease. In July 2026 the FDA agreed that a BLA submission under the accelerated approval pathway is reasonable, and the company expects to submit in the third quarter of 2026, a decisive milestone for its lead program 3.

    SWOT

    Strengths

    • The company has a proprietary gene therapy platform and a pioneering position in Huntington's disease, with multiple regulatory designations 1.
    • The balance sheet was strengthened by the June 2026 offering, extending the funding runway 3.
    • Longer-term data show favourable effects at the high dose, with a manageable safety profile in Phase I/II studies 12.

    Weaknesses

    • Revenues are small and uneven, and the net loss remains large 13.
    • The company depends on one major programme, so any regulatory delay affects the whole portfolio 1.

    Opportunities

    • Extending the miQURE platform to other diseases could create new programmes later 1.
    • The AMT-260 programme could offer a local alternative for refractory epilepsy if the data are confirmed 3.

    Threats

    • The FDA has asked for a randomised study, which could delay or complicate approval 12.
    • Failures in clinical studies or pauses ordered by monitoring committees could seriously affect projects 1.
    • Rising financing costs and dependence on capital markets could limit the company's flexibility 12.

    Risks

    • Rejection of the external-control routehigh

      The FDA has indicated that data from the Phase I/II studies are not sufficient alone for a marketing application, and alignment on the confirmatory study remains under discussion 12.

    • Safety of gene therapiesmedium

      Serious adverse events and dose-limiting toxicities in other programmes have been reported and could lead to further clinical pauses 13.

    • Financing and dilutionmedium

      Share issuances and the floating-rate loan could reduce value for shareholders or limit financing options 12.

    • Manufacturing and enrolment delayslow

      Delays in patient enrolment or manufacturing could lengthen the clinical timeline 1.

    Investment thesis

    What would need to be true (bull case)

    • Four-year data expected in September 2026 could strengthen the case for slowing of disease progression 3.
    • The strengthened balance sheet could fund launch preparation and other programmes without immediate pressure 3.

    What would break the thesis

    • If the FDA requires a randomised study with a standard-of-care control, submission and approval could be considerably delayed 12.
    • Revenues remain low and large net losses could test investor patience if progress stalls 13.
    • Liver events and other reactions in the Fabry and ALS programmes could extend clinical pauses and weigh on the portfolio outlook 13.

    What to watch

    • Completion of AMT-260 second cohort enrolment and updated Phase I/IIa resultsfirst half 2027

    Products, market & competition

    AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

    Possibly outdated: the newest document it read is from 29 Jul 2026; since then the company filed 8-K (04 Nov 2026 · results), 10-Q (04 Nov 2026).

    The business

    uniQure N.V. presents itself as a leader in gene therapy, seeking to deliver single treatments with potentially curative results to patients with rare or devastating diseases 1. Its pipeline includes clinical candidates for Huntington's disease, refractory mesial temporal lobe epilepsy, Fabry disease and SOD1 amyotrophic lateral sclerosis 1. Cash and investments were 622.5 million USD on 31 December 2025 and 810.3 million USD on 30 June 2026 13.

    Revenues are modest and come mainly from licences and collaborations rather than sales of own products 13. The net loss remains significant, so equity offerings and loans are a central part of the funding model 12. The company says its current resources should fund projected operating expenses into 2030 3.

    Segments

    Refractory mesial temporal lobe epilepsy (AMT-260)

    The programme is in the Phase I/IIa GenTLE study in the U.S. Preliminary six-month data in the low-dose cohort showed meaningful seizure reductions in three of six patients, with no related serious adverse events reported 3. Enrolment of the second cohort is expected to complete in the third quarter of 2026 3.

    Market context

    Refractory temporal lobe epilepsy has a sizeable population, and patients with mesial lesions are rarely treated surgically 1. This context could support interest in local therapies such as AMT-260 if clinical data are confirmed 1. The Fabry and SOD1 ALS markets are narrower and remain at early clinical stages 1.

    Trends

    • Stricter regulation of external-control datamixed

      The FDA indicated that data compared with an external control are not sufficient on their own, which could lengthen the approval timeline if alignment does not hold 12. However, the July 2026 agreement on the accelerated route signals regulatory openness 3.

    • Access to capital and loansmixed

      Recent public offerings and the 175 million USD Hercules loan support funding, but interest costs are high 123. If approval is delayed, pressure on financing could increase.

    Competitive position

    In epilepsy, Fabry and ALS, competition comes from approved therapies or other gene therapy developers, and direct comparison depends on future clinical data 1. The company stresses that its edge could come from its proprietary miQURE platform and integrated manufacturing 1.

    • CSL Behring

      Partner mentioned in connection with supply of HEMGENIX, which generated supply costs in 2026 23.

    • Regenxbio

      Licensor of the AAV9 use for the GRIK2 sequence in the AMT-260 programme 1.

    News & filings

    In the press

    The latest news item in our archive is from 01 Oct 2026; the newest SEC filing is from 04 Nov 2026. The press archive comes from the RSS feeds we follow and does not necessarily cover the latest event — the filings alongside do.

    SEC filings

    • Quarterly report04 Nov 2026
    • Current report04 Nov 2026
      Results of operations · Financial statements and exhibits
    • Current report02 Nov 2026
      Regulation FD disclosure · Other events · Financial statements and exhibits
    • Current report29 Sept 2026
      Regulation FD disclosure · Financial statements and exhibits
    • Current report02 Sept 2026
      Regulation FD disclosure · Financial statements and exhibits
    • Quarterly report29 Jul 2026
    • Current report29 Jul 2026
      Results of operations · Financial statements and exhibits
    • Current report24 Jun 2026
      Material agreement · Other events · Financial statements and exhibits
    • Current report22 Jun 2026
      Regulation FD disclosure · Other events · Financial statements and exhibits
    • Current report17 Jun 2026
      Other events · Financial statements and exhibits

    Sources

    1. [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / uniQure N.V. · 02 Mar 2026
    2. [2] Form 10-Q, quarter ended 2026-06-30 · SEC / uniQure N.V. · 29 Jul 2026
    3. [3] Form 8-K, results release (exhibit 99.1) · SEC / uniQure N.V. · 29 Jul 2026

    Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.