BioMarin CEO Bienaimé beats a retreat from Europe, yanking their application for hemophilia A gene therapy
There will be no near-term OK for BioMarin’s hemophilia A gene therapy valrox in Europe.
Already sent back by the FDA to gather more data on durability after researchers flagged a waning response over several years, the EMA had also pinned a request for extended results — though they were willing to take less than the US agency.
The EMA posted a November 4 letter from BioMarin $BMRN saying they were pulling their application — for now — because they wouldn’t have the added data within the time allowed for it.
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