uniQure Announces Third Quarter 2026 Financial Results and Provides Company Update
Globe Newswire•04/11/2026•07:05 ET
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Key Highlights
- ➤FDA granted AMT-130 BLA Priority Review, with May 1, 2027 PDUFA action date
- ➤$768.4 million cash, equivalents and securities expected to fund operations into 2030
- ➤Confirmatory study targets approximately 200 patients, with U.S. screening by end-2026
- ➤Q3 revenue $5.2 million versus $3.7 million; net loss narrowed to $61.2 million
- ➤AMT-130 showed 61% TFC slowing at 48 months, with nominal p=0.008
Expert Statements
Matthew Kapusta, Chief executive officer of uniQure
“Over the last few months, we have made significant progress in our mission to potentially deliver the first disease-modifying therapy to the patients and families living with Huntington’s disease”
Matthew Kapusta, Chief executive officer of uniQure
“We strongly believe AMT-130 has the potential to deliver meaningful benefit to HD patients. With our BLA under Priority Review and preparations for the confirmatory study underway, we are committed to bringing this therapy to patients and families who continue to live with this devastating disease.”
Matthew Kapusta, Chief executive officer of uniQure
“As we continue to build our commercial capabilities and prepare for a potential launch, we are energized by what lies ahead, and our financial strength provides us the runway to deliver on our plans,”
Matthew Kapusta, Chief executive officer of uniQure
“We are grateful to the patients, families and investigators who have made this progress possible, and are honored to continue to work alongside this community.”
~ FDA granted priority review of BLA for ifezuntirgene inilparvovec (AMT-130) in Huntington’s disease; PDUFA target action date of May 1, 2027 ~
~ Aligned with FDA on key elements of confirmatory study design; U.S. patient screening expected to begin by end of 2026 ~
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