UniQure Expects To Resolve FDA Clinical Hold Within Three Months
The gene therapy EtranaDez for hemophilia B placed on clinical hold after a patient was diagnosed with liver cancer, but UniQure points to that patient’s extensive history of liver disease.
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The company will likely have its answer in a matter of weeks, but a link to the vector would be a “worst-case scenario.”
Unveiling its latest data, UniQure is tipped to avoid the knockback which affected BioMarin’s hemophilia A gene therapy, with a filing expected in the second half of 2021.
While M&A-hungry investors were disappointed in no sale, uniQure now aims to pivot toward Huntington’s – and sees Zolgensma as an example to follow.