Neurocrine Bio Soars on Positive Phase 3 Results

Health and Healthcare

Published: October 8, 2015 9:10 am

Last Updated: October 8, 2015 9:12 am

Neurocrine Biosciences Inc. (NASDAQ: NBIX) made waves in the market on Thursday morning, despite a weaker performance from the health care sector over the past month. The company announced positive results in its Phase 3 trial of its highly selective small molecule VMAT2 inhibitor. Basically, NBI-98854 showed a statistically significant reduction in tardive dyskinesia during the six weeks of placebo-controlled treatment in the Kinect 3 clinical trial.

As a side note, this Phase 3 trial included moderate to severe tardive dyskinesia patients with underlying schizophrenia, schizoaffective disorder, bipolar or major depressive disorder.

Overall, these results from the Kinect 3 study demonstrate the potential for NBI-98854 to be a safe and effective treatment for patients suffering from the debilitating effects of tardive dyskinesia. Additional details of this study will be shared at upcoming scientific meetings starting in mid-2016.

For some background, tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities: lip smacking, grimacing, tongue protrusion, facial movements or blinking, puckering and pursing of the lips, or involuntary movements of the limbs. These symptoms are rarely reversible, and there are currently no approved treatments.

Kevin C. Gorman, president and CEO of Neurocrine, said:

We are very pleased with the outstanding efficacy and side effect profile demonstrated by NBI-98854 in the Kinect 3 study. The efficacy data from this pivotal Phase III study completes our placebo-controlled dataset for NBI-98854 in tardive dyskinesia. We will now turn our focus to completing the open-label safety portion of the studies in tardive dyskinesia patients and compiling the data for both doses of NBI-98854 to be included in the New Drug Application we intend to file with the FDA in 2016.

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So far in 2015, Neurocrine is outperforming the market, with the stock up 74% year to date. However, over the past 52 weeks the stock is up over 150%.

Shares of Neurocrine closed Wednesday down 2.7%, at $38.93 in a 52-week trading range of $15.21 to $56.97. In early trading indications Thursday, shares were up 15.3% at $44.90. The stock has a consensus analyst price target of $66.75.

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