In a PhIII showdown with Spark, uniQure switches out its lead gene therapy for hemophilia B
Late last year, the struggling gene therapy biotech uniQure $QURE did some painful cost cutting, dropping programs, axing staff and tailoring the pipeline to concentrate on a hemophilia B program for AMT-060, which they said could be hustled through a pivotal program and into the market, racing with a rival therapy from industry leader Spark Therapeutics.
This morning, though, uniQure executed a quick switch on its lead effort. AMT-060, which had been designated as a breakthrough drug at the FDA, has been replaced by AMT-061. And the execs at uniQure say that both the FDA and the EMA have essentially decided to keep this new drug in their VIP drug program and on the fast track to a registration trial.
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