Neurocrine Biosciences (NBIX 51.16, +9.68), who specializes in developing treatments for difficult to manage conditions in under-served populations, has jumped 23.3% in pre-market after receiving regulatory approval for INGREZZA, used to treat tardive dyskinesia.
Shortly after yesterday's close, the Food and Drug Administration announced that INGREZZA has been approved as the first and only treatment for tardive dyskinesia. Clinical trials showed that INGREZZA had a significant and rapid impact on symptoms of TD when compared to a placebo. The treatment reduced involuntary movement in subjects and did not compromise underlying psychiatric care through 48 weeks of treatment.
Yesterday's approval is notable, since it comes after more than ten years of research and development efforts in this area. The stock has responded accordingly, surging into the neighborhood of its record high from September 2016 ($55.15). Including today's gain, NBIX is already up 32.2% in 2017.
The drug is scheduled to launch on May 1, but the company has yet to announce the cost of treatment.