UNIQURE $QURE Q3’26 EARNINGS HIGHLIGHTS
🔹 Revenue: $5.2M (Est. $6.2M) 🔴; +41% YoY
🔹 EPS: -$0.88 (Est. -$0.92) 🟢
Announcements:
🔹 FDA Priority Review: BLA for ifezuntirgene inilparvovec; PDUFA target action date May 1, 2027
🔹 Confirmatory Study: approximately 200 patients; 2:1 randomization; U.S. screening by end of 2026
🔹 Safety: manageable profile across 51 total treated patients
Other Q3 Metrics:
🔹 Cash & Investments: $768.4M; runway into 2029
🔹 R&D Expenses: $35.5M
🔹 SG&A Expenses: $23.9M
Comments:
🔸 “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.”
🔸 “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,”