Shares of Neurocrine Biosciences soared more than 50 percent in after-markets trading after the San Diego-based developer spelled out the success of a mid-stage trial of elagolix in a population of patients suffering from endometriosis. The gynecological drug hit its co-primary as well as secondary endpoints.
Close to two thirds of the patients taking the drug responded to the treatment, with significant reductions in signs of dysmenorrhea, pelvic pain during menstruation, and non-menstrual pelvic pain, both common symptoms of the disease. Women with the disease, a population of some 100 million women worldwide, have portions of their uterine lining growing outside the womb.
The successful conclusion of the Phase II study, which recruited 137 patients, paves the way for a Phase III that should launch later this year. And that's quite a turnaround from a year ago, when the developer was forced to cut its staff in half during a retrenchment that was triggered by a big setback for its lead program.
"The data from this Daisy PETAL Study allows us to complete our End of Phase II meeting request and finalize the drafting of the Special Protocol Assessment request, both of which we anticipate filing with the FDA in late June," said CEO Kevin C. Gorman. "These results add to the already strong elagolix clinical data package gathered from the almost 1,000 subjects who have participated in Phase I and II studies to date."
- check out Neurocrine's release
- here's the story from Reuters