UniQure Tumbles After ‘Surprising’ Pivot by FDA on Drug Data
UniQure NV plunged Monday after the drug developer said US regulators deemed the clinical data for its experimental gene-therapy for Huntington’s disease as insufficient.
The Amsterdam-based company in a statement said the US Food and Drug Administration no longer agrees that the data from an early-mid stage clinical trial for the treatment — named AMT-130 — is adequate to support the submission of an application to sell the drug.