UniQure gets another shot with hemophilia gene therapy after FDA lifts clinical hold; Neoleukin's IL-2 hopeful also cleared
Months after a disastrous clinical hold on its hemophilia B gene therapy shut down development, uniQure had reason to believe its drug wasn’t to blame for the single case of liver cancer that halted the study. After presenting what it had to the FDA, the biotech will get another shot — and it’s got topline data teed up and ready to go.
Weeks after the biotech determined its gene therapy was likely not linked to a single case of liver cancer, the FDA has lifted a five-month clinical hold on uniQure’s etranacogene dezaparvovec, the company confirmed Monday.
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