Uniqure NV targets UK regulatory approval for Huntington’s gene therapy AMT-130 in Q3 2026 after strong Phase 1/2 trial results.
Uniqure NV (NASDAQ:QURE) shares have climbed 60% in the past month and over 100% year-to-date, driven by progress in its gene therapy pipeline. The company plans to file for regulatory approval of AMT-130, a treatment for Huntington’s disease, with UK regulators in Q3 2026.
Phase 1/2 trial data showed a 75% slowing of disease progression in patients receiving a high dose of AMT-130. Uniqure has engaged with UK regulators to align on data and manufacturing requirements, receiving constructive feedback. The company also plans a meeting with the FDA in Q2 2026 to discuss a potential Phase 3 trial for U.S. approval.
Analysts anticipate further upside, projecting at least a 40% gain for QURE over the next 12 months as the regulatory timeline advances.