Matthew Kapusta

“For the families who avoid generations for treatment for Huntington's disease, this quarter brought meaningful progress. As we announced Monday, the FDA has accepted our Biologics license application for AM2130 and granted priority review with a target PDUFA date of May 1, 2027.”

“To summarize, we entered the second half of 2026 with clarity on a regulatory pathway for AMT-130, both in the U.S. and U.K., with the submission of multiple license applications for AMT-130 and the anticipated release of four-year data, the coming months represent potentially transformational milestones for Unicure…”

“We have had a Type A meeting with the FDA on our lead program in Huntington's disease and have a Type B meeting coming up later this quarter. We had additional data that we presented on our Fabry disease gene therapy that shows continued therapeutic benefit for those patients across multiple doses.”

“During the first quarter of 2026, Unicure remained focused on advancing AMT-130 to patients while continuing to execute across our broader pipeline. Following our Type A meeting with the FDA in January, we acknowledge the agency's feedback and remain focused on engaging constructively to find a feasible path forward.”

“Good morning, everyone, and thank you for joining us on our year-end 2025 conference call. For more than 25 years, Unicure has been driven by a singular mission to deliver transformative medicines to patients living with rare genetic and other debilitating diseases.”