Stock Track | uniQure Plummets 8.82% as Q3 Results Miss Estimates and FDA Feedback Creates Uncertainty

Stock Track11-10

Shares of uniQure NV (QURE) plummeted 8.82% in pre-market trading on Monday, following the release of disappointing third-quarter financial results and uncertainty surrounding regulatory feedback for its key gene therapy program.

The gene therapy company reported a net loss of $80.5 million, or $1.38 per share, for Q3 2025, significantly wider than the $44.4 million loss, or $0.91 per share, in the same period last year. This result missed the analyst consensus estimate of a $0.90 loss per share. Revenue for the quarter came in at $3.7 million, falling short of the $5.24 million expected by analysts, despite showing an increase from $2.3 million in Q3 2024.

Adding to investor concerns, uniQure disclosed that the U.S. Food and Drug Administration (FDA) may no longer agree that data from the Phase I/II studies of AMT-130, its gene therapy for Huntington's disease, is sufficient to support a Biologics License Application (BLA) submission. This unexpected feedback has introduced uncertainty regarding the timing of the BLA submission, potentially delaying the company's path to market for this crucial product. Despite these setbacks, uniQure emphasized its strong cash position of $694.2 million, which it expects will fund operations into 2029, thanks in part to a recent public offering that raised $323.7 million in net proceeds.

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