08:25 AM EST, 11/03/2025 (MT Newswires) -- uniQure (QURE) shares plunged nearly 60% Monday pre-bell after the gene therapy company said the US Food and Drug Administration had changed its position about the data it provided for a Biologics License Application for AMT-130 to treat Huntington's Disease.

uniQure said it believes the FDA currently no longer agrees that the company's data could be enough for approval of its BLA. The company said this is a "key shift" from previous communications with the FDA, and that the timing of the BLA submission for AMT-130 is now unclear.

"We are surprised by the FDA's feedback at the recent pre-BLA meeting, which is a drastic change from the guidance the FDA provided in November 2024," chief executive officer Matt Kapusta said.

The FDA has already granted Breakthrough Therapy designation and Regenerative Medicines Advanced Therapy for AMT-130, the company said.