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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