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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