The biotech “run-up” trade has always attracted a wide-array of traders looking to take advantage of potentially high alpha price moves before the actual catalyst/binary event come to fruition. Case in point: Zogenix (NASDAQ:ZGNX) whose shares are rising over 20% in Thursday’s trading session.
Why the excitement? The orphan-drug maker announced new data from the Phase 3 trial (Study 1504) of ZX008 for the treatment of Dravet syndrome. Fortunately for investors, the trial hit the primary endpoint.
Data from another trial (Study 1) were previously announced in September 2017, showing a 63.9% difference from placebo in reduction in mean monthly convulsive seizures of 0.8mg/kg/day (p<0.001). Additional data from today showed patients receiving 0.5mg/kg/day of ZX008 demonstrated a 54.7% difference from placebo in reduction in mean monthly convulsive seizures (p<0.001) with a median reduction of 62.7% in ZX008 vs. 1.2% in placebo.
“These impressive study results show the significant impact the addition of ZX008 made in reducing the burden of convulsive seizures for patients who are not adequately controlled using stiripentol, the standard of care for the treatment of Dravet syndrome in Europe,” said Professor Rima Nabbout, M.D., Ph.D., Department of Pediatric Neurology, Reference Center for Rare Epilepsies, Necker Enfants Malades Hospital, and Principal Investigator of Study 1504. “If approved, ZX008 has the potential to be a transformative treatment for Dravet syndrome, a rare and serious form of epilepsy with few available treatment options.”
“Patients with Dravet syndrome can often experience frequent, severe convulsive seizures that dramatically impact quality of life for them and their families,” said Linda Laux, M.D., Associate Professor, Pediatrics – Neurology, Ann & Robert H. Lurie Children’s Hospital of Chicago. “For patients who continue to have significant seizures and need new treatments to reduce seizure frequency and improve quality of life, ZX008 may be an exciting and important new treatment option.“
“I would like to extend my gratitude to the patients, families and investigators involved in Study 1504,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “Based on these highly compelling top-line results from both of our pivotal studies, we are now focused on submitting applications for regulatory approvals in the U.S. and Europe in the fourth quarter of 2018. We are excited about ZX008’s potential to have a major impact in the treatment of patients with Dravet syndrome and their families.”