Earnings ·
uniQure reports Q3 net loss of $61.2M; FDA grants Priority Review for Huntington's disease therapy BLA
QUREuniQure N.V.
uniQure N.V. reported a third-quarter 2026 net loss of $61.2 million, or $0.88 per share, compared to an $80.5 million loss in the prior year period. Revenue increased to $5.2 million from $3.7 million due to higher license revenue. The company highlighted that the FDA accepted its Biologics License Application for ifezuntirgene inilparvovec (AMT-130) under the Accelerated Approval pathway and granted it Priority Review, setting a PDUFA target action date of May 1, 2027. Additionally, uniQure reached alignment with the FDA on the design of a confirmatory study for the therapy, with U.S. patient screening expected to begin by the end of 2026. The company held $768.4 million in cash and investment securities as of September 30, 2026, which it expects will fund operations into 2030. uniQure is a gene therapy company developing treatments for severe neurological and metabolic diseases.