NasdaqGS:QUREBiotechs
How Investors Are Reacting To uniQure (QURE) After FDA Rejects Accelerated Path For AMT-130
In early June 2026, uniQure disclosed that the FDA had rejected its data package for accelerated approval of AMT-130 in Huntington’s disease, instead advising a new, lengthy Phase III sham-controlled trial that will delay any potential path to market.
This shift forces uniQure to reconsider the role of AMT-130 as its lead value driver, given the extended timelines, higher costs, and added clinical and regulatory uncertainty.
We’ll now examine how the FDA’s push for a new Phase III...