UniQure Tumbles After ‘Surprising’ Pivot by FDA on Drug Data (1)

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.

UniQure said it plans to urgently interact with the FDA to identify a pathway for accelerated approval. Shares closed down 49% — their worst one-day drop on record.

The FDA’s ...