Impact of Regulatory and Market Developments on uniQure NV
Regulatory setback for AMT‑130
On 3 November 2025, uniQure NV announced that the U.S. Food and Drug Administration had indicated that the data generated in the Phase I/II studies of its investigational gene‑therapy product AMT‑130, intended for Huntington’s disease, were insufficient to support a Biologics License Application (BLA). The company stated that the FDA no longer agreed that the available evidence would meet the regulatory requirements for a primary BLA submission. Consequently, the timing of a potential BLA filing for AMT‑130 became uncertain.
The disclosure triggered a sharp decline in the company’s share price, falling more than 50 % from a close of $67.69 on 31 October 2025 to $34.29 on 3 November 2025.
Investor‑law firm investigation
Kessler Topaz Meltzer & Check, LLP announced that it is conducting an investigation into possible violations of federal securities laws on behalf of investors who suffered significant losses following the AMT‑130 announcement. The firm is encouraging affected shareholders to contact them for further information, and has provided a dedicated online form and direct contact details for inquiries.
Market‑wide bearish sentiment
On 26 November 2025, trading data showed an unusually high volume of put options on uniQure. A total of 6,020 put contracts were traded, double the expected volume, with the most active strikes being 20 and 15 dollar puts expiring on 25 December 2025. The put/call ratio stood at 5.12, indicating a predominance of bearish positions. Implied volatility for at‑the‑money options increased by more than one point during the day.
The next earnings release is scheduled for 26 February 2026, at which time the company will report its Q3 2025 results and further clinical progress.
Summary of key facts
| Item | Detail |
|---|---|
| Exchange | Frankfurt Stock Exchange (ticker: QURE) |
| Currency | EUR |
| Current closing price (26 Nov 2025) | 23.48 EUR |
| 52‑week high | 60.5 EUR (29 Oct 2025) |
| 52‑week low | 5.442 EUR (1 Dec 2024) |
| Market capitalisation | 1.6 billion EUR |
| P/E ratio | –6.272 |
| Core focus | Gene therapy for severe genetic diseases; clinical programmes in hemophilia B and pre‑clinical proof‑of‑concept in Huntington’s disease |
| Recent regulatory event | FDA indicated AMT‑130 data insufficient for BLA |
| Legal investigation | Kessler Topaz Meltzer & Check, LLP investigating potential securities‑law violations |
| Trading anomaly | Put volume 6,020 contracts; put/call ratio 5.12 on 26 Nov 2025 |
These developments underscore the challenges uniQure faces in advancing its gene‑therapy pipeline, the regulatory scrutiny surrounding its Huntington’s disease program, and the heightened bearish sentiment among investors.
