Back in September, shares of Neurocrine Biosciences ($NBIX) were subjected to a beating at the hands of investors unhappy with the news that the 50-mg dose of its experimental therapy for a rare movement disorder failed the primary endpoint in a Phase IIb study--even though the 100-mg dose performed as hoped. Last night, the biotech experienced a dramatic improvement in its fortunes as a 75-mg dose delivered the goods in a follow-up Phase IIb trial.
Shares of Neurocrine ($NBIX) shot up 60% on the successful study of NBI-98854, a small-molecule VMAT2 inhibitor designed to treat tardive dyskinesia. And with the mid-stage program wrapped on a positive note, the company says it's ready to ask the FDA for a meeting in advance of a pivotal, late-stage trial.
"The profound response in this Kinect 2 study demonstrates the potential of NBI-98854 as both a safe and highly effective treatment for patients suffering from tardive dyskinesia," said
There are no therapies for this disease, which had helped spur some enthusiasm for the drug among some analysts.
Neurocrine's lead program is for elagolix, an endometriosis therapy that won a $575 million deal back in 2010 with Abbott ($ABT), which later spun off its drug business as AbbVie ($ABBV). That's still the primary focus of the company and analysts. A Phase III study for that drug was launched in 2012, and the partners say they can file for an approval in 2016, provided the data are right.
- here's the release