UNIQURE $QURE Q3โ26 EARNINGS HIGHLIGHTS
๐น Revenue: $5.2M (Est. $6.2M) ๐ด; +41% YoY
๐น EPS: -$0.88 (Est. -$0.92) ๐ข
Announcements:
๐น FDA Priority Review: BLA for ifezuntirgene inilparvovec; PDUFA target action date May 1, 2027
๐น Confirmatory Study: approximately 200 patients; 2:1 randomization; U.S. screening by end of 2026
๐น Safety: manageable profile across 51 total treated patients
Other Q3 Metrics:
๐น Cash & Investments: $768.4M; runway into 2029
๐น R&D Expenses: $35.5M
๐น SG&A Expenses: $23.9M
Comments:
๐ธ โWe 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.โ
๐ธ โAs 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,โ