QURE uniQure Inc.
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Executive Summary
uniQure reported financial results for 2025, showing a revenue decline to $16.1 million and a reduced net loss of $199.0 million, or $3.46 per share, compared to $239.6 million in 2024. The company highlighted clinical progress in its gene therapy pipeline, particularly durable data for AMT-130 in Huntington’s disease, but disclosed that the FDA rejected the use of external controls for approval and mandated a randomized Phase III trial. With $622.5 million in cash, uniQure is funded into 2029.
Key Financial Metrics
Actionable Insight
While clinical data for AMT-130 remains strong, the FDA's insistence on a costly and time-consuming Phase III trial introduces significant development risk and timeline uncertainty. The strengthened balance sheet supports long-term funding, but investors should monitor the design and feasibility of the future trial, as well as safety developments in AMT-191 and AMT-162.
Key Facts
- Revenue decreased to $16.1 million in 2025 from $27.1 million in 2024, driven by lower collaboration and contract manufacturing revenue.
- Net loss narrowed to $199.0 million ($3.46/share) from $239.6 million ($4.92/share) in 2024.
- FDA rejected approval pathway for AMT-130 based on single-arm trial with external controls; required a randomized, sham-controlled Phase III study.
- AMT-130 showed statistically significant 75% slowing in disease progression at 36 months in high-dose patients.
- Cash, cash equivalents, and investments totaled $622.5 million as of December 31, 2025, up from $367.5 million in 2024.
- Cash runway now extends into the second half of 2029, supported by $404.2 million raised in public offerings in 2025.
- Development of AMT-191 paused due to dose-limiting liver toxicities; AMT-162 enrollment remains on hold after a serious adverse event.
Financial Impact
Revenue down $11 million YoY; net loss reduced by $40.6 million; cash increased by $255 million primarily from equity financing.
Risk Factors
- FDA requirement for a sham-surgery controlled trial for AMT-130 increases development cost, timeline, and ethical/enrollment challenges.
- Clinical holds and safety concerns in AMT-191 and AMT-162 could delay or derail other pipeline programs.
- Dilution risk from prior share issuances (11.8M shares + 0.5M pre-funded warrants) may weigh on shareholder sentiment despite improved cash position.
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3247245 |
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Jun 12, 2026
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Insider Cluster
| $27.57 awaiting T+1 | awaiting T+1 | — | $27.57 (+0.02%) |
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| $27.57 awaiting T+1 | awaiting T+1 | — | $27.57 (+0.02%) |
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| $27.57 awaiting T+1 | awaiting T+1 | — | $27.57 (+0.02%) |
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| $27.57 awaiting T+1 | awaiting T+1 | — | $27.57 (+0.02%) |
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Jun 11, 2026
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| $26.81 awaiting T+1 | awaiting T+1 | — | $27.57 (+2.85%) |
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| $26.81 awaiting T+1 | awaiting T+1 | — | $27.57 (+2.85%) |
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| $26.81 awaiting T+1 | awaiting T+1 | — | $27.57 (+2.85%) |
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Jun 3, 2026
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| $29.88 $27.99 | ▼ −6.33% | ▼ −6.72% | $27.57 (−7.73%) |
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May 5, 2026
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8-K
| $21.16 $22.82 | ▲ +7.84% | ▲ +6.46% | $27.57 (+30.29%) |
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May 5, 2026
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Press Release
| $21.16 $22.82 | ▼ −7.84% | ▼ −6.46% | $27.57 (−30.29%) |
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