XBiotech Inc (NASDAQ:XBIT) is tanking in midday trading today, currently down $6.61 – or 39 percent – to $10.41. The sudden drop arrived on the heels of the announcement yesterday evening that the company attended a less-than-successful meeting with the European Medicines Agency (EMA) regarding its colorectal cancer therapy.
According to XBiotech, the EMA held a negative “trend” vote after discussing with the company its “Day 180 List of Outstanding Issues.” The talks were in regard to the company’s marketing authorization application (MAA).
When a negative trend vote occurs, it signifies that it is unlikely that the Committee for Medicinal Products for Human Use (CHMP) will render a positive opinion for the company’s MAA. A formal decision will be voted on next month, and, now, there may be additional hurdles that XBiotech has to jump over if it wants to win marketing approval for its product.
At the meeting, which was an “Oral Explanation” meeting, XBiotech gave a 20-minute presentation followed by a round of questions and answers with members of the CHMP in regards to its MAA. These types of meeting are designed to allow pharmaceutical companies the chance to clarify any data in order to support its application for marketing authorization.
According to XBiotech’s President and Chief Executive Officer, John Simard, the company’s management is “disappointed” by the results of the Oral Explanation 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,” Simard told shareholders in a press release yesterday. “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 added that the EMA’s application process includes a possibility to appeal a negative decision, and the company might go that route “at the appropriate time.”
The author of this article holds not position in any of the companies mentioned above.