Shares of XBiotech (XBIT) were down 33.1% to $11.39 in premarket trading on Friday. Austin, Texas-headquartered XBiotech said late Thursday that the European Medicines Agency had rendered a negative "trend" vote following a meeting with company to discuss the "Day 180 List of Outstanding Issues" in connection with the marketing authorization application for the company's candidate antibody for colorectal cancer treatment.
"We are disappointed by the outcome of the meeting," said XBiotech president and CEO John Simard in a statement. "We believe that the data speak in a clear and resounding voice to clinical relevance of a new antibody therapy in advanced colorectal cancer. 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 noted that the marketing authorization application procedure enables the appeal of negative decisions from the oral explanation and added that XBiotech "may seek access to this process at the appropriate time."
Meanwhile, shares of Atara Biotherapeutics (ATRA) rose 5.8% to $20 in premarket trading on Friday. The South San Francisco, Calif.-based firm after the market close on Thursday unveiled positive interim results from a phase one trial of the autologous version of ATA188 in patients with primary and secondary progressive multiple sclerosis.
And on Friday morning, Atara said it has inked a clinical trial collaboration pact with Merck MRK that will evaluate Atara's allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T lymphocytes, or ATA129, in tandem with Merck's anti-PD-1 (programmed death receptor-1) therapy, Keytruda, in patients that have platinum resistant or recurrent EBV-associated NPC.
Other biotech stock movers include Bellicum Pharmaceuticals (BLCM) , whose shares were up 3.7% to $14.50. Houston-based Bellicum focuses on cellular immunotherapies for cancers and orphan inherited blood disorders.