uniQure Q3 net loss $80.5M; FDA creates uncertainty for AMT-130 BLA

uniQure N.V.

2025-Q3 EPS reported -$2.90 revenue$10,530,000

Net loss of $80.5M ($1.38 loss per share) vs $44.4M loss in Q3 2024; revenue $3.7M (+$1.4M YoY).
Cash, cash equivalents and investments $694.2M as of Sept 30, 2025; raised ~$323.7M net from public offering.
AMT-130 Phase I/II topline: 75% slowing in cUHDRS (p=0.003), 60% in TFC (p=0.033) at 36 months vs external control.
Pre-BLA meeting with FDA: FDA no longer agrees Phase I/II data vs external control may support BLA; submission timing unclear.
R&D expenses $34.4M (+$3.8M YoY) driven by $6.6M in BLA preparation; SG&A $19.4M (+$7.8M YoY).

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