Uniqure (QURE) stock crashed Monday on "confusing" and "unexpected" feedback from the Food and Drug Administration for its Huntington's disease gene therapy.

The company "believes that the FDA currently no longer agrees that the 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 (biologics license agreement) submission."

Uniqure described the feedback as a "key shift from prior communications," and said the timing of its plan to ask for approval of AMT-130 is now unclear.

Leerink Partners analyst Joseph Schwartz said the news is a "confusing" and "unexpected" twist.

"QURE has been thoroughly aligned with the FDA over the past year, has breakthrough therapy designation and the data update QURE presented in September was very strong," he said in a note.

In premarket trades, Uniqure stock plummeted 59.3% to 27.57.

https://www.investors.com/news/technology/uniqure-stock-huntingtons-gene-therapy-fda-feedback/