uniQure N.V. (QURE), a gene therapy company, announced Monday that the company received final meeting minutes from the U.S. Food and Drug Administration (FDA) regarding a Type A meeting held on January 30, 2026 to discuss AMT-130, an investigational gene therapy for Huntington's disease (HD).
The FDA stated that it cannot agree that data from the Phase I/II studies, compared to an external control, are sufficient to provide the primary evidence of effectiveness required to support a marketing application for AMT-130.
The FDA strongly recommended uniQure conduct a prospective, randomized, double-blind, sham surgery-controlled study.
uniQure intends to continue engaging with the FDA regarding Phase III development considerations and plans to request a Type B meeting in the second quarter of 2026 to further discuss potential study design approaches.
"We remain committed to engaging with the FDA to determine a clear, scientifically grounded, and efficient path forward for AMT-130," said Matt Kapusta, chief executive officer at uniQure.
In Monday's pre-market trading, QURE is trading on the Nasdaq at $9.10, down $6.53 or 41.77 percent.
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