Kythera jumps on Phase III data for ATX-101
Kythera Biopharmaceuticals Inc. (NASDAQ:KYTH) gained $8.42 (25%) to $41.95 on Tuesday after reporting that ATX-101 met the co-primary endpoints vs. placebo in each of the identical Phase III REFINE-1 and REFINE-2 trials to reduce submental (under chin) fat. Monthly injections of the synthetic sodium deoxycholate for up to six cycles significantly improved the proportion of patients with a simultaneous improvement of at least one grade from baseline on the Clinician Reported-Submental Fat Rating Scale (CR-SMFRS) and Patient Reported-Submental Fat Rating Scale (PR-SMFRS) and the proportion of patients with a simultaneous improvement of at least two grades from baseline on the scales (p<0.001 for all). The double-blind, North American trials enrolled 506 and 516 patients, respectively. Data will be presented at the American Society for Dermatologic Surgery meeting in Chicago in October. ...