Thursday, 13 April 2017 08:15 AM
Upcoming AWS Coverage on SteadyMed Post-Earnings Results
LONDON, UK / ACCESSWIRE / April 13, 2017 / Active Wall St. blog coverage looks at the headline from Neurocrine Biosciences, Inc. (NASDAQ: NBIX) as the Company announced on April 11, 2017 that the US Food and Drug Administration (FDA) has approved INGREZZA(valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). Register with us now for your free membership and blog access at:
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One of Neurocrine Biosciences' competitors within the Drugs - Generic space, SteadyMed Ltd. (NASDAQ: STDY), reported on March 29, 2017, its financial results for the fourth quarter and full year ended December 31, 2016. AWS will be initiating a research report on SteadyMed in the coming days.
Today, AWS is promoting its blog coverage on NBIX; touching on STDY. Get all of our free blog coverage and more by clicking on the link below:
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What is TD?
TD is characterized by uncontrollable, abnormal, and repetitive movements in certain upper body muscles. The condition is caused by treatments that block dopamine receptors in the brain, such as antipsychotics and other medications, which are commonly prescribed to treat mental illnesses such as schizophrenia, bipolar disorder, and depression. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect at least 500,000 people in the US.
Details about INGREZZA
INGREZZA is a novel, selective vesicular monoamine transporter-2 (VMAT2) inhibitor. It is the first and only FDA-approved product indicated for this rare and incapacitating movement disorder.
Clinical studies have shown that INGREZZA provides significant, rapid, and meaningful improvement in TD signs and symptoms compared to placebo through six weeks, with continued reductions in TD observed through 48 weeks of treatment. In clinical trials, no worsening in safety scale scores for depression, suicidal ideation or behaviors was observed. INGREZZA has been studied in over 1,000 individuals and more than 20 clinical trials.
The approval of INGREZZA was based on data from the Kinect 3 study, a Phase III, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study comparing once-daily INGREZZA 80mg and 40mg to placebo over six weeks in patients with underlying schizophrenia, schizoaffective disorder or mood disorder. Subsequent to the completion of the six-week placebo-controlled dosing, all subjects were placed on once-daily 40mg or once-daily 80mg of INGREZZA through week 48. INGREZZA met the primary endpoint in this study with a mean change from baseline to week six in the AIMS dyskinesia total score of -3.2 for the 80mg once-daily group as compared to -0.1 in the placebo group.
INGREZZA inhibits VMAT2 and is thought to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with TD. VMAT2 is a protein in the brain that packages neurotransmitters, such as dopamine, for transport and release in presynaptic neurons. INGREZZA, developed in Neurocrine's laboratories, is novel in that it selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic, or muscarinic receptors. Additionally, INGREZZA can be taken together with psychiatric medications such as antipsychotics or antidepressants.
Neurocrine received breakthrough therapy designation from the FDA for INGREZZA for the treatment of TD, and the New Drug Application was evaluated by the FDA with priority review.
"The often-debilitating effects of tardive dyskinesia have left people feeling isolated and forgotten. The approval of INGREZZA represents a turning point for these patients and their care partners, offering a meaningful treatment where before there was little hope," said Kevin C. Gorman, Chief Executive Officer of Neurocrine Biosciences, "For the past 20 years, Neurocrine has been devoted to developing treatments for difficult to manage conditions in underserved patient populations. We are committed to ensuring that those impacted by the disruptive effects of TD have access to INGREZZA."
Moving Forward
Neurocrine plans to launch INGREZZA in the distribution channel next week and will be available through a select pharmacy network. The Company will start a wider scale promotion on May 01, 2017.
Stock Performance
At the close of trading session on Wednesday, April 12, 2017, following the announcement, Neurocrine Biosciences' stock price surged 24.88% to end the day at $51.80. A total volume of 13.09 million shares were exchanged during the session, which was above the 3-month average volume of 1.01 million shares. The Company's share price has gained 33.85% on YTD basis. The stock currently has a market cap of $4.50 billion.
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