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uniQure N.V. (QURE)
NASDAQ:QURE
US Market

uniQure (QURE) Earnings Dates, Call Summary & Reports

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Earnings Data

Report Date
May 12, 2026
TBA (Confirmed)
Period Ending
2026 (Q1)
Consensus EPS Forecast
-0.89
Last Year’s EPS
-0.82
Same Quarter Last Year
Moderate Buy
Based on 12 Analysts Ratings

Earnings Call Summary

Q4 2025
Earnings Call Date:Mar 02, 2026|
% Change Since:
|
Earnings Call Sentiment|Neutral
The call communicated major positive clinical advances (notably strong 3‑year AMT‑130 efficacy, supportive Fabry and TLE data) and a strengthened balance sheet, but these were tempered by significant regulatory resistance from the FDA (recommendation for a sham‑controlled Phase III), safety‑related pauses/holds in two programs (AMT‑191 dosing pause and AMT‑162 hold), and a substantial year‑over‑year revenue decline. Management emphasized active regulatory engagement, continued data generation (4‑year AMT‑130 analysis) and pursuit of ex‑U.S. pathways and early access options, while acknowledging material uncertainty around Phase III design, cost and feasibility.
Company Guidance
The key regulatory guidance from the call was that the FDA reaffirmed it is unlikely to accept Phase I/II data versus an external control as primary evidence and strongly recommended a randomized, double‑blind, sham surgery‑controlled Phase III study (discussed at an October 2025 pre‑BLA and a Type A meeting on Jan 30, 2026, with minutes received Feb 27), prompting uniQure to plan a Type B meeting in Q2 2026 to discuss Phase III design and to amend the Phase I/II SAP to include a 4‑year analysis expected in Q3 2026 (including 12 patients at 4 years and all patients reaching 3 years); uniQure noted its 3‑year AMT‑130 data showed a 75% slowing on the composite UHDRS and 60% slowing on Total Functional Capacity with reductions in neurofilament light versus an Enroll HD external comparator (>30,000 participants, 14 years of data), but the 12‑month sham‑controlled U.S. cohort showed no worsening at 12 months, which influenced FDA views; the company will pursue constructive FDA dialogue, ex‑U.S. regulator discussions (e.g., EMA/MHRA), and feasibility work (including patient burden/ethical considerations around multiyear sham surgery), while continuing program updates (AMT‑191: 11 patients, all off ERT, dose‑dependent alpha‑Gal A increases durable >1 year to 4 months with 2 mid‑dose Grade 3 LFTs leading to a dosing pause; AMT‑260: six patients in Cohort 1 with ≥6 months follow‑up and Cohort 2 enrollment expected complete by midyear) and citing a cash balance of $622.5M as of 12/31/25 (vs. $367.5M a year earlier, including ~$404.2M raised) with runway into H2 2026.
AMT-130: Robust 3‑Year Clinical Efficacy
Phase I/II 3‑year data demonstrated a statistically significant 75% slowing of disease progression on the composite UHDRS and a 60% slowing on Total Functional Capacity versus an external Enroll HD comparator; reduction in neurofilament light and supportive trends across other clinically meaningful endpoints. Company plans a 4‑year analysis in Q3 2026 and intends to amend the SAP and submit the analysis to regulators.
AMT-191 (Fabry): Durable Enzyme Activity and ERT Withdrawal
Preliminary Phase I/II data from 11 patients showed dose‑dependent elevation in alpha‑Gal A enzyme activity durable from 4 months up to >1 year; as of the call all 11 patients have been withdrawn from enzyme replacement therapy.
AMT-260 (Temporal Lobe Epilepsy): Early Promising Signals
Case study of first patient with up to 6 months follow‑up showed a promising reduction in seizure frequency and no serious adverse events; enrollment completed for five additional patients in cohort 1 (six total) with cohort 2 enrollment underway and a planned Q2 update on six patients with ≥6 months follow‑up.
Strong Cash Position and Capital Raise
Cash, cash equivalents and investment securities totaled $622.5 million at Dec 31, 2025 vs $367.5 million at Dec 31, 2024, an increase of ~$255.0 million (+69.4%), primarily from ~$404.2 million in proceeds from public offerings and prefunded loans; company expects cash to fund operations into the second half of 2026.
Operational Efficiency from Divestiture
Cost of contract manufacturing revenues was nil in 2025 versus $17.1 million in 2024 following the 2024 divestiture of the Lexington manufacturing facility; R&D 'other' costs decreased by $26.0 million driven by lower employee/contractor/severance and facility costs.
Regulatory Engagement and Global Pathway Strategy
Company is actively engaging the FDA (Type B planned for Q2 2026), pursuing dialogue with ex‑U.S. regulators (MHRA, EMA and others), and evaluating named‑patient/early access programs and ex‑U.S. regulatory pathways to accelerate patient access.
Strong Community and KOL Support
Broad advocacy from the Huntington's disease community and positive feedback from neurosurgeons, neurologists and HD centers of excellence reinforce clinical interest and urgency for regulatory flexibility and access.

uniQure (QURE) Earnings, Revenues Date & History

The upcoming earnings date is based on a company’s previous reporting, and may be updated when the actual date is announced

QURE Earnings History

Report Date
Fiscal Quarter
Forecast / EPS
Last Year's EPS
EPS YoY Change
Press Release
Slides
Play Transcript
May 12, 2026
2026 (Q1)
-0.89 / -
-0.82
Mar 02, 2026
2025 (Q4)
-0.91 / -0.57
-1.4961.74% (+0.92)
Nov 10, 2025
2025 (Q3)
-0.90 / -1.38
-0.91-51.65% (-0.47)
Jul 29, 2025
2025 (Q2)
-0.90 / -0.69
-1.1640.52% (+0.47)
May 09, 2025
2025 (Q1)
-1.00 / -0.82
-1.3639.71% (+0.54)
Feb 27, 2025
2024 (Q4)
-0.65 / -1.49
-1.521.97% (+0.03)
Nov 05, 2024
2024 (Q3)
-0.99 / -0.91
-1.8851.60% (+0.97)
Aug 01, 2024
2024 (Q2)
-1.25 / -1.16
-1.4419.44% (+0.28)
May 07, 2024
2024 (Q1)
-1.28 / -1.36
-1.6316.56% (+0.27)
Feb 26, 2024
2023 (Q4)
-1.46 / -1.52
0.15-1113.33% (-1.67)
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed

QURE Earnings-Related Price Changes

Report Date
Price 1 Day Before
Price 1 Day After
Percentage Change
Mar 02, 2026
$15.63$10.50-32.82%
Nov 10, 2025
$27.79$26.15-5.90%
Jul 29, 2025
$14.98$13.68-8.68%
May 09, 2025
$12.25$12.79+4.41%
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.

FAQ

When does uniQure N.V. (QURE) report earnings?
uniQure N.V. (QURE) is schdueled to report earning on May 12, 2026, TBA (Confirmed).
    What is uniQure N.V. (QURE) earnings time?
    uniQure N.V. (QURE) earnings time is at May 12, 2026, TBA (Confirmed).
      Where can I see when companies are reporting earnings?
      You can see which companies are reporting today on our designated earnings calendar.
        What companies are reporting earnings today?
        You can see a list of the companies which are reporting today on TipRanks earnings calendar.
          What is QURE EPS forecast?
          QURE EPS forecast for the fiscal quarter 2026 (Q1) is -0.89.