On Friday, shares of pharmaceutical company Zogenix Inc. ZGNX are skyrocketing, and as of 1:05 PM EST, the stock is trading up over 171% to $34.90 per share. ZGNX closed the day on Thursday at $12.88 per share, meaning the small biotech firm has nearly tripled in value so far today.
Zogenix announced positive results from its first Phase 3 study of ZX008, which achieved its primary endpoint. ZX008 is used to treat Dravet syndrome, a rare form of epilepsy. The study tested 119 patients, both children and young adults, and one of the three dosage groups experienced an average 64% reduction in monthly convulsive seizures compared to the placebo.
Previously known as Severe Myoclonic Epilepsy of Infancy (SMEI), Dravet syndrome begins in the first year of life, and affects 1 in 15,700 individuals. Frequent and prolonged seizures are the most common symptom, but individuals can also suffer from behavioral and developmental delays, movement and balance issues, delayed language and speech issues, and even orthopedic conditions, among others.
"These results are truly exciting and demonstrate, in a large multicenter controlled trial, the impressive efficacy of low-dose fenfluramine for patients with Dravet syndrome," said Joseph Sullivan M.D., director of the Pediatric Epilepsy Center in UCSF Benioff Children's Hospital San Francisco and principal investigator of Study 1 in the U.S., in a statement.
In addition to meeting its primary endpoints, Zogenix said that ZX008 showed statistically significant improvements versus the placebo in all vital secondary measures.
Zogenix expects results from a second trial in the first half of next year. CEO Stephen Farr also said that the company "[remains] on track to submit applications for regulatory approvals in the U.S. and Europe in the second half of 2018."
As a result, fellow biotech company GW Pharmaceuticals GWPH saw its shares drop on Friday, and in afternoon trading, GWPH was trading down about 7%. GW announced last year positive results from its own Phase 3 trial for a Dravet syndrome treatment. Called Epidiolex, the drug is a cannabinoid-based product, and is one of the company's leading CBD treatments.
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