Shares of uniQure NV (QURE) plummeted 8.82% in pre-market trading on Monday following the release of disappointing third-quarter financial results and unexpected regulatory challenges for its key gene therapy program.
The gene therapy company reported a wider-than-expected Q3 net loss of $80.5 million, or $1.38 per share, significantly missing the analyst consensus estimate of $0.90 loss per share. Revenue for the quarter came in at $3.7 million, falling short of the $5.8 million expected by analysts. Despite a year-over-year increase in revenue, primarily driven by higher license revenues, the market focused on the substantial net loss and missed expectations.
Adding to investor concerns, uniQure disclosed that recent feedback from the U.S. Food and Drug Administration (FDA) has introduced uncertainty regarding the timing of its Biologics License Application (BLA) submission for AMT-130, its investigational gene therapy for Huntington's disease. The company revealed that the FDA "no longer agrees that data from the Phase I/II studies of AMT-130 in comparison to an external control may be adequate to provide the primary evidence in support of a BLA submission." This unexpected shift in the regulatory landscape has cast doubt on the program's near-term prospects, despite positive clinical data showing statistically significant slowing of disease progression at 36 months.
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