BioCentury
ARTICLE | Company News

XBiotech hammered after negative EMA vote

April 21, 2017 7:07 PM UTC

XBiotech Inc. (NASDAQ:XBIT) lost $6.79 (40%) to $10.23 on Friday after saying EMA issued a negative “trend” vote for the company's MAA for colorectal cancer candidate Hutruo (Xilonix). The company said the vote means it is unlikely EMA’s CHMP will recommend the candidate at its May meeting, and that “additional steps" will be required to gain an approval. XBiotech, which announced the news after market close Thursday, said it might appeal the vote.

The vote followed a meeting with EMA Thursday at which XBiotech attempted to address major objections related to Hutruo’s clinical relevance raised in CHMP's Day 180 questions regarding the MAA. ...

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