Key Developments: Neurocrine Biosciences Inc (NBIX.O)
12.01USD
22 May 2013
$-0.05 (-0.41%)
$12.06
$12.06
$12.53
$11.91
434,893
516,113
$12.85
$6.25
Latest Key Developments (Source: Significant Developments)
Neurocrine Biosciences Inc Reaffirms FY 2013 Guidance-Conference Call
Neurocrine Biosciences Inc announced that financial guidance for fiscal 2013 remains unchanged and expects approximately $3 million of revenue and net loss to be $50 million to $55 million. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $3.07 million and net income of $(52) million for fiscal 2013. Full Article
Neurocrine Biosciences Inc Announces Start of Phase IIb Study of Elagolix in Uterine Fibroids
Neurocrine Biosciences Inc announced that a Phase IIb clinical trial to evaluate elagolix for the treatment of uterine fibroids has been initiated. Elagolix is an oral gonadotropin-releasing hormone (GnRH) antagonist, in development by AbbVie for the treatment of uterine fibroids and endometriosis. Neurocrine and AbbVie entered into a collaboration and license agreement for elagolix during 2010. The Phase IIb uterine fibroids study is a randomized, parallel, double-blind, placebo-controlled clinical trial evaluating elagolix in women with heavy uterine bleeding associated with uterine fibroids. This study will evaluate 280 subjects over a six-month placebo-controlled dosing period. The primary efficacy endpoint of the study is an assessment of the change in menstrual blood loss utilizing the alkaline hematin method comparing baseline to month six. Additional secondary efficacy endpoints will be evaluated including assessing the change in fibroid volume and hemoglobin. Bone mineral density will be assessed via DXA scan at baseline, the conclusion of dosing, and six months post-dosing. Full Article
Neurocrine Biosciences Inc Issues FY 2013 Guidance
Neurocrine Biosciences Inc announced that for fiscal 2013, it expects revenue to approximate $3 million which consists solely of the amortization of up-front license fees and net loss to be $50 to $55 million, or $0.75 to $0.83 loss per share based on 66.5 million basic shares outstanding. Full Article
Neurocrine Biosciences Inc Announces Start Of Second Phase IIb Study Of VMAT2 Inhibitor Nbi-98854 For Treatment Of Tardive Dyskinesia
Neurocrine Biosciences Inc announced that it has initiated a Phase IIb clinical trial (Kinect 2 Study) of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854. The design of this six-week Phase IIb study is a randomized, parallel, double-blind, placebo-controlled, dose titration trial of 90 subjects with moderate to severe tardive dyskinesia and underlying mood disorders, gastrointestinal disorders, and schizophrenia or schizoaffective disorder. Topline data is expected in mid-2013. The Kinect 2 Study is a randomized, parallel, double-blind, placebo-controlled, dose titration Phase IIb clinical trial utilizing the capsule formulation of NBI-98854 in moderate to severe tardive dyskinesia patients with an underlying mood disorder (e.g., bipolar disorder), schizophrenia or schizoaffective disorder, or a gastrointestinal disorder with exposure to metoclopramide. This 90 subject study will assess once-daily NBI-98854 over a six-week placebo-controlled dosing period. Half of the randomized subjects will receive placebo and half will receive NBI-98854. The NBI-98854 dosing regimen will begin with a once-daily dose of 25mg for the initial two weeks. At the completion of the initial two weeks of dosing, based on certain efficacy and safety criteria, patients may be titrated to a once-daily 50mg dose, or continue on the once-daily 25mg dose for the following two-week period. Full Article
Abbott Laboratories In Cooperation With Neurocrine Biosciences, Inc. Announces Initiation Of Phase 3 Study Of Elagolix In Patients With Endometriosis
Abbott Laboratories, in cooperation with Neurocrine Biosciences, Inc. announced the initiation of a pivotal Phase 3 clinical trial designed to evaluate the safety and efficacy of elagolix in female patients with endometriosis. Elagolix is an oral gonadotropin-releasing hormone (GnRH) antagonist. The Phase 3 trial (M12-665) is a 24-week, multinational, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of elagolix in 875 women, age 18 to 49, with moderate-to-severe endometriosis-associated pain. It will be conducted at approximately 160 sites in the United States, Puerto Rico and Canada. A second pivotal Phase 3 study is planned with an NDA filing targeted in 2016. Elagolix inhibits gonadatropin releasing hormone (GnRH) receptors in the pituitary gland and ultimately reduces circulating sex hormone levels. To date, elagolix has been studied in over 20 clinical trials totaling more than 1,000 subjects. A Phase 2a trial of elagolix for the treatment of uterine fibroids is also ongoing. Full Article
Neurocrine Biosciences Inc Issues FY 2012 Guidance Below Analysts' Estimates
Neurocrine Biosciences Inc announced that for fiscal 2012, it expects revenue to be in the range of $40-$45 million which includes amortization of up-front license fees of approximately $34 million. Net loss for fiscal 2012 is expected to be $9 to $14 million, or $0.14 to $0.21 loss per share (EPS) based on 66 million basic shares outstanding. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $47 million, net income of $(1.7) million and EPS of $(0.01) for fiscal 2012. Full Article
Neurocrine Biosciences Inc Announces Exercise In Full Of Underwriters' Option To Purchase Additional Shares
Neurocrine Biosciences Inc announced the closing of the sale of 1,425,000 shares of its common stock pursuant to the exercise in full of an option to purchase such shares granted to the underwriters of Neurocrine's previously announced public offering of common stock that priced on January 19, 2012. Including the additional shares purchased, the offering totaled 10,925,000 shares at a public offering price of $8.10 per share, resulting in gross proceeds of approximately $88.5 million to Neurocrine, before deducting underwriting discounts and commissions and other offering expenses. Jefferies & Company, Inc. and Deutsche Bank Securities Inc. acted as joint book-running managers for this offering, and Piper Jaffray & Co. and Leerink Swann LLC acted as co-managers for this offering. Neurocrine anticipates using the net proceeds from the offering to fund its research and development efforts, and for general corporate purposes, including working capital. Full Article
Neurocrine Biosciences Inc Announces FDA Granted Fast Track Designation For VMAT2 Inhibitor NBI-98854
Neurocrine Biosciences Inc announced that its VMAT2 inhibitor product candidate, NBI-98854, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of neuroleptic-induced tardive dyskinesia. The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious diseases and address unmet medical needs. Full Article
Neurocrine Biosciences Inc Prices Public Offering of Common Stock
Neurocrine Biosciences Inc announced the pricing of an underwritten public offering of 9,500,000 shares of its common stock at a price to the public of $8.10 per share. The gross proceeds to Neurocrine from this offering, before deducting underwriting discounts and commissions and other offering expenses payable by Neurocrine, are expected to be approximately $77 million. The offering is expected to close on or about January 24, 2012, subject to customary closing conditions. Jefferies & Company, Inc. and Deutsche Bank Securities Inc. are acting as joint book-running managers for this offering, and Piper Jaffray & Co. and Leerink Swann LLC are acting as co-managers for this offering. Neurocrine anticipates using the net proceeds from the offering to fund its research and development efforts, and for general corporate purposes, including working capital. Full Article
Neurocrine Biosciences Inc Announces Proposed Public Offering Of Common Stock
Neurocrine Biosciences Inc announced that it is offering to sell shares of its common stock in an underwritten public offering. Jefferies & Company, Inc. and Deutsche Bank Securities Inc. are acting as joint book-running managers for this offering, Piper Jaffray & Co. and Leerink Swann LLC are acting as co-managers for this offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Full Article
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