Furiex skyrockets on Phase III IBS-D data

Furiex Pharmaceuticals Inc. (NASDAQ:FURX) jumped $59.72 (130%) to $105.69 on Tuesday after reporting that twice-daily 100 mg oral eluxadoline met both the FDA-defined and EMA-defined primary endpoint in a pair of double-blind, international Phase III trials to treat diarrhea-predominant irritable bowel syndrome (IBS-D). The FDA-defined endpoint was a composite responder rate from baseline to week 12 vs. placebo, and the EMA-defined endpoint was the rate from baseline to week 26 vs. placebo. A 75 mg dose of eluxadoline met the FDA-defined primary endpoint in both trials; the low-dose also met the EMA-defined endpoint in the 1,146-patient Phase III Study 3002, but missed the endpoint in the 1,282-patient Phase III Study 3001.

Next quarter, Furiex plans to submit an NDA to FDA for eluxadoline to treat IBS-D. A European submission for the locally acting mu opioid receptor agonist and delta opioid receptor antagonist slated for 1Q15. ...