Zogenix soars on Phase III data for Dravet syndrome candidate

Zogenix Inc. (NASDAQ:ZGNX) rocketed $22.17 (172%) to $35.05 on Friday, adding $550 million in market cap, after reporting that ZX008 as adjunctive therapy met the primary endpoint in the Phase III Study 1 to treat Dravet syndrome. Top-line data from the second Phase III trial -- Study 1504 -- of ZX008 to treat Dravet syndrome are expected next half, with regulatory submissions in the U.S. and EU to follow in 2H18.

On the primary endpoint, once-daily 0.8 mg/kg ZX008 reduced mean monthly convulsive seizure frequency from baseline to week 14 by 63.9% vs. placebo (p<0.001). ZX008 led to a median reduction in monthly convulsive seizure frequency of 72.4% vs. 17.4% for placebo. ZX008 also met all secondary endpoints, including a greater proportion of patients who achieved a greater than or equal to 50% and 75% reduction in monthly convulsive seizures and of improving longest seizure-free interval, vs. placebo. Zogenix said a once-daily 0.2 mg/kg dose of ZX008 also met the endpoints vs. placebo...