Core Insights - The law firm Kessler Topaz Meltzer & Check, LLP is investigating potential violations of federal securities laws on behalf of investors of uniQure N.V. [1] - On November 3, 2025, uniQure announced that the FDA indicated insufficient evidence from its AMT-130 gene therapy data to support a Biologics License Application (BLA) submission [2] - Following this announcement, uniQure's stock price plummeted over 50%, from $67.69 on October 31, 2025, to $34.29 on November 3, 2025 [3] Company Developments - uniQure's AMT-130, an investigational gene therapy for Huntington's disease, is facing regulatory challenges as the FDA no longer considers the Phase I/II study data adequate for BLA submission [2] - The timing for the BLA submission for AMT-130 has become uncertain due to the FDA's feedback [2] Market Reaction - The significant drop in uniQure's stock price reflects investor concerns regarding the viability of AMT-130 and its potential market approval [3]
QURE Investigation Notification: Kessler Topaz Meltzer & Check, LLP Encourages uniQure N.V. (NASDAQ: QURE) Investors with Significant Losses to Contact the Firm