Stock Alert: Zogenix (ZGNX) Plunges 29%

(RTTNews) - Shares of Zogenix Inc. (ZGNX) are down over 29%, following mixed results from its global phase III clinical trial of its lead investigational therapy, FINTEPLA in Lennox-Gastaut Syndrome, a severe and treatment-resistant childhood-onset epilepsy.

The trial achieved its primary endpoint, demonstrating a statistically significant reduction in drop seizures for FINTEPLA 0.7 mg/kg/day compared to placebo. The same dose of FINTEPLA (0.7 mg/kg) also demonstrated statistically significant improvements versus placebo in key secondary efficacy measures, including the proportion of patients with a clinically meaningful reduction in drop seizure frequency.

However, for a lower dose of FINTEPLA (0.2 mg/kg/day), although there was a decrease in the frequency of drop seizures between baseline and the treatment period compared to placebo, it did not reach statistical significance.

Stephen Farr, President and CEO of Zogenix, said, "We are pleased with the top-line efficacy and safety results from Study 1601, which highlight FINTEPLA's potential to be an important new treatment option for one of the most difficult to treat rare epilepsies. We look forward to working with regulatory agencies to potentially bring FINTEPLA to the LGS patient community."

FINTEPLA for the treatment of seizures associated with Dravet syndrome is under Priority Review by the FDA, with a decision date set for March 25, 2020. The drug candidate is also under review by the European Medicines Agency for the indication of Dravet syndrome.

As of this writing, ZGNX is currently at $37.13, down 29.44%.