Zogenix, Inc. (NASDAQ: ZGNX) stock surged over 16.4% on July 12th, 2018 (as of 12:39 PM; Source: Google finance) on positive top-line results from their second confirmatory Phase 3 study (Study 1504) for its investigational drug, ZX008 (low-dose fenfluramine hydrochloride), for treating children and young adults with Dravet syndrome. Overall the stock generated an outstanding returns this year, delivering over 216% in one year (Source: Finviz)
Zogenix’s first pivotal Phase 3 study, met the primary endpoint and all major secondary endpoints, showing ZX008, at a dose of 0.5 mg/kg/day (maximum 20 mg/day), which is superior to placebo when added to a stiripentol regimen. These results show a major impact on the addition of ZX008 made in decreasing 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. ZX008 has the potential to be a transformative treatment for Dravet syndrome, a rare and serious form of epilepsy with few available treatment options. The group is on track to submit an MAA in Europe by year-end and have started the process of pre-submission meetings with several national authorities and the EMA.
As per their first quarter of 2018 performance, the firm did not report any revenue for the three months ending March 31, 2018 against total revenue of $2.7 million in pcp. But, Research and development expenses reached $23 million during the quarter against $13.3 million in pcp. The group’s enrolling patients was ongoing while expanded the scope of their Phase III studies and programs for ZX0008 in both the U.S. and Europe in Dravet syndrome and LGS.
The company reported a total net loss of $30.2 million or $0.87 per share the first quarter ending March 31, 2018, as compared with a total net loss of $21.3 million or $0.86 per share in the first quarter ended — in the prior year. As of March 31, 2018, the group had cash and cash equivalents of $272 million as compared to a cash balance of $294 million December 31, 2017. The timeline for a rolling NDA submission was also agreed.