uniQure loses $1B after FDA rejects Huntington’s data, Aardvark falls on cardiac safety signal, and more

The week’s clinical roundup features surprising guidance from FDA on uniQure’s proposed Huntington’s study, Aardvark’s 56% slide on a Phase III safety signal, and early results from AtaiBeckley’s MDMA therapy in social anxiety disorder.

On Monday, uniQure N.V. (NASDAQ:QURE) received an recommendation from FDA to conduct a study that includes a sham brain surgery as a control, noting the company’s existing Phase I/II data, which uses a natural history comparator, is insufficient to support approval of its Huntington’s disease gene therapy...