NasdaqGS:QUREBiotechs
UniQure Lawsuits Put AMT-130 FDA Setback And Narrative Under Scrutiny
Multiple securities fraud class action lawsuits have been filed against uniQure (NasdaqGS:QURE) over disclosures related to its Huntington’s disease gene therapy AMT-130.
Investors claim the company misrepresented the likelihood and timing of FDA approval, following a regulatory setback in which the FDA no longer agreed that Phase I/II data supported a licensure application.
Comments from the FDA Commissioner that raised questions about AMT-130’s safety and efficacy have intensified scrutiny...