UniQure Falls as FDA Seeks Controversial Gene Therapy Study (1)

UniQure NV’s shares plunged after US regulators said the company should conduct another study of its Huntington’s disease gene therapy before it’s approved, the most recent example of the Trump administration slowing treatment for a rare disease.

The US Food and Drug Administration “strongly recommended” the company conduct a clinical trial that would require some patients to undergo a sham brain surgery, it said in a statement. UniQure said it plans to request another meeting with the agency in the second quarter to discuss potential study designs.

“We have a moral obligation, given the strength of our data, ...