FDA rejects AMT-130 Phase I/II data as sufficient for approval; recommends randomized sham-controlled study

uniQure N.V.

Net loss of $199.0M for 2025 vs $239.6M in 2024; revenue $16.1M down 41% YoY.
Cash and investments $622.5M, expected to fund operations into H2 2029.
FDA stated Phase I/II data vs external control insufficient for marketing application; strongly recommends prospective, randomized, double-blind, sham surgery-controlled study.
Company plans to request Type B meeting in Q2 2026 to discuss Phase III study design.
AMT-260 MTLE Phase I/IIa enrollment completed in first cohort; data expected H1 2026.

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