NasdaqGS:QUREBiotechs
UniQure Faces AMT-130 Scrutiny As FDA Shifts And Lawsuits Weigh
uniQure (NasdaqGS:QURE) faces multiple securities class action lawsuits focused on disclosures around its AMT-130 gene therapy program.
Federal health officials have criticized the company for alleged data manipulation tied to AMT-130.
The FDA has withdrawn support for a Biologics License Application for AMT-130, complicating the program's regulatory path.
Upcoming changes in FDA leadership are expected to affect how AMT-130 and related filings are reviewed.
These developments arrive at a...