uniQure reports Q1 EPS (82c), consensus (93c)

Reports Q1 revenue $1.567M, consensus $5.9M. “We continued to have constructive interactions with the U.S. Food and Drug Administration in the first and second quarters of 2025, enabling us to further advance AMT-130 towards a planned Biologics License Application submission,” said Matt Kapusta, chief executive officer of uniQure (QURE). “The recently granted Breakthrough Therapy designation is a significant milestone and underscores the FDA’s continued engagement with AMT-130 as a potential disease-modifying treatment for Huntington’s disease. We expect to provide a regulatory update in the second quarter, including guidance on the potential timing of our BLA submission for AMT-130, and anticipate sharing new clinical data from our AMT-130 Phase I/II trials in the third quarter. As we prepare for potential commercialization, we remain committed to making financially disciplined investments.”