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Notice of QURE Investigation: Kessler Topaz Meltzer & Check, LLP Encourages uniQure N.V. (NASDAQ: QURE) Investors with Significant Losses to Contact the Firm

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RADNOR, Pa., Jan. 17, 2026 /PRNewswire/ -- The law firm of Kessler Topaz Meltzer & Check, LLP (www.k...

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AI Summary

uniQure's stock plummeted over 50% after the FDA deemed data insufficient for its AMT-130 BLA. Consequently, the BLA submission timeline is uncertain, prompting investigations into potential securities law violations and concerns among investors.

Sentiment Rationale

Recent developments, especially regulatory setbacks, can lead to significant declines in stock prices. Historically, companies in biotech facing regulatory rejections often see sustained bearish trends, as seen with Amarin Corporation's fallen shares following FDA feedback.

Trading Thesis

Bearish outlook on QURE; expect continued volatility in the near term.

Market-Moving

  • FDA's assessment significantly impacts investor confidence in AMT-130.
  • Ongoing investigations may lead to further legal scrutiny and stock instability.
  • The unclear future of AMT-130 could deter potential partnerships or investments.

Key Facts

  • Kessler Topaz investigating uniQure for potential securities law violations.
  • FDA found insufficient evidence for AMT-130's Biologics License Application.
  • uniQure's stock dropped over 50% following FDA announcement.
  • The BLA submission timeline for AMT-130 is now unclear.
  • Investors encouraged to seek legal counsel due to stock price collapse.

Companies Mentioned

  • uniQure N.V. (QURE): Facing regulatory setbacks and stock price volatility.

Corporate Developments

This situation falls under Corporate Developments due to potential violations of securities laws and regulatory challenges impacting the company's market position and stock performance. Such developments could deter investor interest and impact future financing opportunities for QURE.

uniQure N.V. (NASDAQ: QURE) Faces Investigation Following FDA Notice Impacting Stock Price

Kessler Topaz Meltzer & Check, LLP has announced an ongoing investigation into possible violations of federal securities laws on behalf of investors in uniQure N.V. (NASDAQ: QURE). This follows a recent press release from uniQure regarding significant regulatory challenges concerning its investigational gene therapy, AMT-130, for Huntington's disease.

Details on the FDA Notification

On November 3, 2025, uniQure revealed that the FDA determined the data provided for AMT-130 did not offer adequate evidence to support the company's Biologics License Application (BLA). The firm expressed concerns that the FDA no longer considers the data from its Phase I/II studies sufficient as primary evidence for the BLA, leading to uncertainty regarding the timeline for AMT-130's submission.

Stock Price Repercussions

The announcement triggered a dramatic reaction in the stock market, with uniQure's stock price plummeting more than 50%. Specifically, the share price fell from a closing value of $67.69 on October 31, 2025, to $34.29 by November 3, 2025.

Investor Guidance

Investors in uniQure who have experienced significant losses are encouraged to learn more about this investigation. Interested parties can fill out an online form or reach out to Kessler Topaz Meltzer & Check, LLP directly. Jonathan Naji, Esq. can be contacted at (484) 270-1453 or via email at info@ktmc.com. For further assistance, you can also visit this link.

Kessler Topaz Meltzer & Check, LLP Overview

Kessler Topaz Meltzer & Check, LLP (KTMC) is a prominent U.S. law firm dedicated to securities fraud class actions and investor protection. The firm represents a wide range of clients, including individual investors, major pension funds, and international asset managers. KTMC has achieved considerable recoveries in securities litigation and has received multiple accolades, including:

  • The National Law Journal's Plaintiff's Hot List
  • BTI Consulting Group's Honor Roll of Most Feared Law Firms
  • The Legal Intelligencer's Class Action Firm of the Year
  • Lawdragon's Leading Plaintiff Financial Lawyers
  • Law360's Titans of the Plaintiffs Bar

The firm's presence extends globally, with offices located in Pennsylvania and California. For additional information about KTMC, please visit www.ktmc.com.

Contact Information

For more inquiries, please contact:

Kessler Topaz Meltzer & Check, LLP
Jonathan Naji, Esq.
280 King of Prussia Road
Radnor, PA 19087
(484) 270-1453
info@ktmc.com

This notice may be considered attorney advertising in certain jurisdictions. Past results do not guarantee future outcomes.

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