XBiotech Inc. (NASDAQ:XBIT) rolled off 40.04% or $6.82 to $10.20 per share on April 21, after announcing that its marketing authorization application (MAA) related to its candidate antibody for treating colorectal cancer received a negative “trend” vote from the European Medicines Agency (EMA). “We are disappointed by the outcome of the meeting. We believe that the data speak in a clear and resounding voice to clinical relevance of a new antibody therapy in advanced colorectal cancer, XBiotech Inc. (NASDAQ:XBIT) President and CEO John Simard said.
A negative trend vote means it is unlikely that a positive Committee for Medicinal Products for Human Use (CHMP) opinion related to the company’s MAA will be attained at the formal decision vote scheduled in May, and that additional steps would need to be taken to potentially gain marketing approval.
“We believe that findings from our Phase III study show that we have developed an important endpoint and methodology to evaluate anti-cancer therapy in advanced stage disease and that our monoclonal antibody represents a breakthrough treatment in patients with advanced colorectal cancer,” Simard said in a press release.
We see XBIT shares trading at a very high volume versus its average volume today while its price per share is falling nearer to the lower end of its 52-week range.
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The Bottom Line
XBiotech Inc. (NASDAQ:XBIT) shares are down tremendously by 40% intraday after receiving a negative “trend” vote to its marketing application related to a candidate antibody to treat colorectal cancer. For further reading, here are 10 best cancer hospitals in the world.