William Blair downgrades uniQure on uncertain path forward

William Blair downgraded uniQure (QURE) to Market Perform from Outperform without a price target The company announced that following a recent meeting, it believes the FDA no longer agrees that the data from the Phase I/II trial of AMT-130 in comparison to external controls support an application submission because the statistical analysis plan was not proposed prior to the start of the trial, the analyst tells investors in a research note. The firm views the development as a “significant divergence” from the guidance provided by the agency in November 2024. Blair believes the path forward for AMT-130 is now uncertain.