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Neurocrine Biosciences Inc (NBIX.O)

NBIX.O on Nasdaq

43.23USD
2 Dec 2016
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Latest Key Developments (Source: Significant Developments)

Neurocrine says INGREZZA NDA for treatment of tardive dyskinesia has been accepted for priority review by U.S. FDA
Tuesday, 11 Oct 2016 06:55am EDT 

Neurocrine Biosciences Inc : Neurocrine announces INGREZZA™ (valbenazine) new drug application for the treatment of tardive dyskinesia has been accepted for priority review by U.S. FDA .Neurocrine Biosciences Inc- INGREZZA application has been given a prescription drug user fee act (PDUFA) target action date of April 11, 2017.  Full Article

Neurocrine announces FDA conditional acceptance of Ingrezza
Wednesday, 31 Aug 2016 04:02pm EDT 

Neurocrine Biosciences Inc : Neurocrine announces FDA conditional acceptance of proprietary name Ingrezza™ for VMAT2 inhibitor valbenazine .Expects to receive notification of acceptance of NDA filing, as well as timeframe for NDA review from FDA in October 2016.  Full Article

Neurocrine submits NDA for Valbenazine
Monday, 29 Aug 2016 04:02pm EDT 

Neurocrine Biosciences Inc : Submits new drug application for Valbenazine for treatment of tardive dyskinesia .Expects to receive notification of acceptance of NDA, as well as timeframe for NDA review from FDA in october 2016..  Full Article

Neurocrine Biosciences Q2 loss per share $0.46
Wednesday, 3 Aug 2016 04:02pm EDT 

Neurocrine Biosciences Inc : Neurocrine biosciences reports second quarter 2016 results . Q2 earnings per share view $-0.49 -- Thomson Reuters I/B/E/S .Q2 loss per share $0.46.  Full Article

Neurocrine Biosciences Inc announces positive results from phase III kinect 3 study of nbi-98854 in tardive dyskinesia
Thursday, 8 Oct 2015 06:30am EDT 

Neurocrine Biosciences Inc:Announces positive results from phase III kinect 3 study of nbi-98854 in tardive dyskinesia.Says study meets primary endpoint, submission of new drug application planned for 2016.Nbi-98854 showed statistically significant reduction in tardive dyskinesia during six weeks of placebo-controlled treatment.Says during the six-week placebo-controlled treatment period nbi-98854 was generally well tolerated.Clinical hematology, chemistry and ecg monitoring indicated no emergent safety signals.A separate 1-year open-label safety study of nbi-98854 been initiated to support the 2016 filing of nda in tardive dyskinesia.  Full Article

Neurocrine Biosciences Inc and Mitsubishi Tanabe Pharma Corp announce agreement to develop and commercialize VMAT2 Inhibitor NBI-98854 for movement disorders in Japan and other select Asian markets
Tuesday, 31 Mar 2015 10:00pm EDT 

Neurocrine Biosciences Inc:Says that it has entered into exclusive collaboration and licensing agreement for development and commercialization of its VMAT2 inhibitor, NBI-98854, in Japan and other select Asian markets with Mitsubishi Tanabe Pharma Corp.Mitsubishi Tanabe intends to initially develop NBI-98854 in Japan for chorea associated with Huntington's disease and tardive dyskinesia.Neurocrine retains full commercial rights to NBI-98854 in North America, Europe and other countries outside of Asia.Under terms of agreement, Neurocrine will receive an initial payment of $30 million and is eligible to receive up to $85 million in additional milestone payments associated with the development and commercialization of NBI-98854 in Asia.Upon commercialization, Neurocrine will receive royalties on product sales from Mitsubishi Tanabe territories in Asia.Neurocrine will also support Mitsubishi Tanabe's clinical efforts in developing NBI-98854 for patients suffering from chorea associated with Huntington's disease and tardive dyskinesia.  Full Article

Neurocrine Biosciences Inc announces exercise in full of underwriters' option to purchase additional shares
Friday, 20 Feb 2015 07:00am EST 

Neurocrine Biosciences Inc:Says that the underwriters of its previously announced public offering have exercised in full their option to purchase an additional 1,041,600 shares of Neurocrine's common stock at the public offering price of $36.00 per share, less underwriting discounts and commissions.As a result, the total number of shares being sold in the public offering is 7,985,600 shares.Closing of the sale of all the shares in the offering is expected to occur on or about Feb. 24.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.Cowen and Company, LLC and Nomura Securities International, Inc. are acting as co-managers for this offering.  Full Article

Neurocrine Biosciences Inc prices public offering of common stock
Thursday, 19 Feb 2015 07:00am EST 

Neurocrine Biosciences Inc:Prices underwritten public offering of 6,944,000 shares of common stock at a price to public of $36.00 per share.Gross proceeds are expected to be about $250 mln.Offering is expected to close on or about Feb. 24.To use net proceeds 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.Cowen and Company, LLC and Nomura Securities International, Inc. are acting as co-managers for this offering.  Full Article

Neurocrine Biosciences Inc announces proposed public offering of $225 mln of common stock
Tuesday, 17 Feb 2015 04:08pm EST 

Neurocrine Biosciences Inc:Commences underwritten public offering of shares of common stock to raise aggregate proceeds of about $225 mln.In connection with this offering, Neurocrine will also grant to the underwriters a 30-day option to purchase up to an additional 15 pct of the number of shares sold.J.P. Morgan Securities LLC and Deutsche Bank Securities Inc. are acting as joint book-running managers for this offering.Anticipates using the net proceeds to fund research and development efforts, to prepare for commercialization efforts and for general corporate purposes, including working capital.  Full Article

Neurocrine Biosciences announces granting of orphan drug status for NBI-77860 in congenital adrenal hyperplasia
Friday, 16 Jan 2015 02:30pm EST 

Neurocrine Biosciences Inc:Announces that NBI-77860, a corticotropin releasing factor 1 (CRF) receptor antagonist, has been granted orphan drug status by the United States FDA for the treatment of congenital adrenal hyperplasia a disease that affects about 20,000-30,000 people in the United States.Orphan Drug Designation is granted by the FDA Orphan Drug Designation program for medicines intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.  Full Article

BRIEF-Neurocrine Biosciences announces FDA advisory committee meeting to review Ingrezza NDA

* Neurocrine announces FDA advisory committee meeting to review Ingrezza (valbenazine) new drug application for the treatment of tardive dyskinesia