TheFinalCD
8 years ago
Neurocrine Announces FDA Approval of INGREZZA™ (valbenazine) Capsules as the First and Only Approved Treatment for Adults w...
Neurocrine Biosciences, Inc. (MM) (NASDAQ:NBIX)
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Today : Tuesday 11 April 2017
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SAN DIEGO, April 11, 2017 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has approved INGREZZA™ (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). INGREZZA, a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first and only FDA-approved product indicated for the treatment of adults with TD.
Experience the interactive Multimedia News Release here: https://www.multivu.com/players/English/8074551-neurocrine-ingrezza-valbenazine-fda-approval
"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."
"Until now, one of the few options for physicians, when managing TD, was to stop, change or lower the dose of antipsychotic medication, potentially jeopardizing patients' psychiatric stability," said Christoph U. Correll, MD, Professor, Psychiatry and Molecular Medicine, Hofstra Northwell School of Medicine. "In clinical trials, INGREZZA significantly and rapidly improved TD symptoms compared to placebo, reducing involuntary movements acutely and through 48 weeks of treatment without compromising underlying psychiatric care. These results, combined with convenient once-daily dosing, represent a tremendous breakthrough for patients suffering from TD."
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. INGREZZA was generally well tolerated, with somnolence as the only adverse event occurring at a rate greater than or equal to 5 percent and twice placebo. 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.
"A treatment for tardive dyskinesia is a welcome and exciting step in the continued effort to destigmatize mental health conditions," said Paul Gionfriddo, President & CEO of Mental Health America. "With an FDA approved treatment now available, individuals and doctors can have more productive and proactive conversations about TD."
"The FDA's approval of INGREZZA represents the culmination of over ten years of dedicated effort from the Neurocrine research and development teams," said Christopher F. O'Brien, MD, Neurocrine's Chief Medical Officer. "Neurocrine would like to thank the many clinical investigators and TD patients who participated in our clinical trials. Without their partnership and commitment, we would not have been able to achieve this tremendous breakthrough."
INGREZZA will be in the distribution channel next week and will be available through a select pharmacy network. Promotion to healthcare professionals will commence on May 1, 2017. To assist TD patients in gaining access to INGREZZA, Neurocrine has created the INBRACETM patient support program, which will immediately begin accepting treatment initiation forms from health care professionals prescribing INGREZZA and work closely with patients and their families to facilitate access. INBRACE is designed to provide personalized product assistance and services. For more information, patients may visit www.INGREZZA.com or call 1-84-INGREZZA (1-844-647-3992).
Conference Call
Neurocrine will hold a live conference call today at 5:30pm ET (2:30pm PT). Participants can access the live conference call by dialing 866-610-1072 (US) or 973-935-2840 (International) using the conference ID 99380770. The call and slide presentation can also be accessed via webcast through the Company's website at www.neurocrine.com.
If you are unable to attend the webcast and would like further information on this announcement, please contact the Investor Relations Department at Neurocrine Biosciences at (858) 617-7600. A replay of the conference call will be available approximately one hour after the conclusion of the call by dialing 800-585-8367 (US) or 404-537-3406 (International) using the conference ID 99380770. The call will be archived for approximately two weeks.
About Tardive Dyskinesia (TD)
TD is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face. 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 U.S.
About INGREZZA
INGREZZA, a selective VMAT2 inhibitor, is the first and only product indicated for the treatment of adults with tardive dyskinesia. 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 (p<0.0001). Also in the Kinect 3 study:
The percentage of participants who achieved at least a 50% reduction in AIMS was 40 percent (p<0.001) in participants receiving 80mg/day of INGREZZA compared to only 8.7 percent of those who received placebo.
INGREZZA was found to be generally well tolerated, with somnolence as the only adverse event occurring at a rate of 5 percent or greater and twice placebo.
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.
Breakthrough Therapy Designation was received from the FDA for INGREZZA for the treatment of TD, and the New Drug Application was evaluated by the FDA with priority review.
Important Safety Information
INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.
INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval.
The most common adverse reaction (5% or greater and twice the rate of placebo) is somnolence.
Please see INGREZZA full Prescribing Information at www.INGREZZA.com.
About Neurocrine Biosciences
Neurocrine Biosciences is a San Diego based biotechnology company focused on neurologic, psychiatric and endocrine related disorders. The Company's three late-stage clinical programs are: elagolix, a gonadotropin-releasing hormone antagonist for women's health that is partnered with AbbVie Inc.; opicapone, a novel, once-daily, peripherally-acting, highly-selective catechol-o-methyltransferase inhibitor under investigation as adjunct therapy to levodopa in Parkinson's patients; and INGREZZA™ (valbenazine), a novel, once-daily, selective VMAT2 inhibitor under investigation for the treatment of Tourette Syndrome.
Neurocrine Biosciences, Inc. news releases are available through the Company's website at http://www.neurocrine.com.
stocktrademan
9 years ago
$NBIX recent news/filings
bullish optionable
hidden bullish divergence
bullish engulfing candlestick
stochastics crossing up out of the oversold area
## source: finance.yahoo.com
Tue, 25 Aug 2015 18:59:02 GMT ~ Biotech Expert Talks Potential M&A Activity, Partnerships And Women's Health
read full: http://finance.yahoo.com/news/jason-napodano-biotech-potential-m-185902784.html
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Tue, 25 Aug 2015 14:05:36 GMT ~ 3 Top Jefferies Growth Stocks to Buy After Sell-Off
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read full: http://247wallst.com/investing/2015/08/25/3-top-jefferies-growth-stocks-to-buy-after-sell-off/
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Thu, 13 Aug 2015 12:59:13 GMT ~ Neurocrine Announces Completion of Enrollment into Kinect 3 Tardive Dyskinesia Study
[at noodls] - SAN DIEGO, Aug. 13, 2015 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that it has recently completed subject randomization of the Phase III clinical trial (Kinect 3 Study) ...
read full: http://www.noodls.com/view/37B9245AC048BD453A75E6CE694695C6DBC0AD1A
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Thu, 13 Aug 2015 12:00:00 GMT ~ Neurocrine Announces Completion of Enrollment into Kinect 3 Tardive Dyskinesia Study
[PR Newswire] - SAN DIEGO, Aug. 13, 2015 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NBIX) announced today that it has recently completed subject randomization of the Phase III clinical trial (Kinect 3 Study) of its proprietary Vesicular Mono-Amine Transporter 2 (VMAT2) compound NBI-98854 in tardive dyskinesia patients. The design of the Kinect 3 Study is a randomized, parallel-group, double-blind, placebo-controlled trial of approximately 240 subjects with moderate to severe tardive dyskinesia and an underlying diagnosis of mood disorder, schizophrenia or schizoaffective disorder. The initial six weeks of treatment consists of an efficacy and safety assessment of 80mg and 40mg once-daily NBI-98854 against placebo. This will be followed by an additional 42 weeks of long-term safety assessment where all subjects are randomized in a blinded fashion to either 80mg or 40mg once-daily NBI-98854. Topline efficacy data from the initial six week assessment is expected in the fourth quarter of 2015.
read full: http://finance.yahoo.com/news/neurocrine-announces-completion-enrollment-kinect-120000787.html
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Wed, 05 Aug 2015 17:04:08 GMT ~ NEUROCRINE BIOSCIENCES INC Financials
read full: http://finance.yahoo.com/q/is?s=nbix
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$NBIX charts
basic chart ## source: stockcharts.com
basic chart ## source: stockscores.com
big daily chart ## source: stockcharts.com
big weekly chart ## source: stockcharts.com
$NBIX company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/NBIX/company-info
Ticker: $NBIX
OTC Market Place: Not Available
CIK code: 0000914475
Company name: Neurocrine Biosciences, Inc.
Incorporated In: CA, USA
$NBIX share structure
## source: otcmarkets.com
Market Value: $3,982,798,599 a/o Aug 31, 2015
Shares Outstanding: 85,873,191 a/o Jul 24, 2015
Float: Not Available
Authorized Shares: Not Available
Par Value: 0.001
$NBIX extra dd links
Company name: Neurocrine Biosciences, Inc.
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=NBIX+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=NBIX+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=NBIX+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/NBIX/news - http://finance.yahoo.com/q/h?s=NBIX+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/NBIX/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/NBIX/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=NBIX+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/NBIX
DTCC (dtcc.com): http://search2.dtcc.com/?q=Neurocrine+Biosciences%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Neurocrine+Biosciences%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Neurocrine+Biosciences%2C+Inc.&x=0&y=0
## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/NBIX
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/sec-filings
Edgar filings (sec.gov): http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000914475&owner=exclude&count=40
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/NBIX/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/NBIX/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=NBIX&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=NBIX
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/NBIX/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=NBIX+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=NBIX+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=NBIX
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=NBIX
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=NBIX+Cash+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/NBIX/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=NBIX+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/NBIX.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=NBIX
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/NBIX/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/NBIX/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/NBIX
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/NBIX
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/NBIX:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=NBIX
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=NBIX
$NBIX DD Notes ~ http://www.ddnotesmaker.com/NBIX
UserAlias1
10 years ago
Neurocrine Biosciences, Inc. Prices Public Offering of Common-Stock
Last update: 19/02/2015 7:00:46 am
SAN DIEGO, Feb. 19, 2015 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the pricing of its underwritten public offering of 6,944,000 shares of its common stock at a price to the public of $36.00 per share. The gross proceeds to Neurocrine from this offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Neurocrine, are expected to be approximately $250 million. The offering is expected to close on or about February 24, 2015, subject to customary closing conditions. Neurocrine anticipates using the net proceeds from the offering to fund its research and development efforts, to prepare for commercialization efforts and for general corporate purposes, including working capital.
J.P. Morgan Securities LLC and Deutsche Bank Securities Inc. are acting as joint book-running managers for this offering, Jefferies LLC and Barclays Capital Inc. are acting as co-lead managers for this offering and Cowen and Company, LLC and Nomura Securities International, Inc. are acting as co-managers for this offering. Neurocrine has granted the underwriters a 30-day option to purchase up to an aggregate of 1,041,600 additional shares of common stock.
The securities described above are being offered by Neurocrine pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC") on February 25, 2014, which became automatically effective by rule of the SEC upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC's website at www.sec.gov, and a final prospectus supplement relating to the offering will be filed with the SEC. The offering is being conducted only by means of the prospectus supplement and accompanying prospectus, copies of which may be obtained (when available) from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or from Deutsche Bank Securities Inc., Attention: Prospectus Group, 60 Wall Street, New York, NY 10005-2836, or by phone at 1-800-503-4611, or by email at prospectus.CPDG@db.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Neurocrine Biosciences
Neurocrine Biosciences, Inc. discovers and develops innovative and life-changing pharmaceuticals, in diseases with high unmet medical needs, through its novel R&D platform, focused on neurological and endocrine based diseases and disorders. Neurocrine's two lead late-stage clinical programs are elagolix, a gonadotropin-releasing hormone (GnRH) antagonist for women's health that is partnered with AbbVie Inc., and a wholly owned vesicular monoamine transporter 2 (VMAT2) inhibitor for the treatment of movement disorders. Neurocrine intends to maintain certain commercial rights to its VMAT2 inhibitor and evolve into a fully-integrated pharmaceutical company.
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties such as those, among others, relating to Neurocrine's expectations regarding the completion, timing and size of its public offering and the expected proceeds therefrom. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the offering, as well as risks and uncertainties associated with Neurocrine's business and finances in general, and the other risks described in Neurocrine's annual report on Form 10-K for the year ended December 31, 2014. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
To view the original version on PR Newswire, visit:www.prnewswire.com/news-releases/neurocrine-biosciences-inc-prices-public-offering-of-common-stock-300038237.html
SOURCE Neurocrine Biosciences, Inc.
/CONTACT: Neurocrine Biosciences, Investor Relations, +1-858-617-7600
/Web site: http://www.neurocrine.com
(END) Dow Jones Newswires
February 19, 2015 07:00 ET (12:00 GMT)
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