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Neurocrine Biosciences Inc (NBIX.OQ)

NBIX.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Abbvie And Neurocrine Biosciences Announce PDUFA Target Date Of Q3 2018 For Elagolix In Endometriosis Associated Pain
Tuesday, 10 Apr 2018 08:15am EDT 

April 10 (Reuters) - Abbvie And Neurocrine Biosciences Announce Pdufa Target Date Of Q3 2018 For Elagolix In Endometriosis ::ASSOCIATED PAIN.FDA REQUIRES EXTENDED TIME FOR REVIEW OF ADDITIONAL INFORMATION IN NEW DRUG APPLICATION.BASED ON ABBVIE'S REVIEW OF DATA, COMPANY REMAINS CONFIDENT IN NDA AND CONTINUES TO WORK WITH FDA TO BRING ELAGOLIX TO PATIENTS.REGULATORY SUBMISSIONS FOR ELAGOLIX IN UTERINE FIBROIDS REMAIN ON TRACK.PRESCRIPTION DRUG USER FEE ACT DATE HAS BEEN EXTENDED THREE MONTHS TO Q3 2018 FOR ELAGOLIX.  Full Article

Abbvie Announces Positive Topline Results From Phase 3 Study Evaluating Investigational Elagolix In Women With Uterine Fibroids
Wednesday, 21 Feb 2018 08:00am EST 

Feb 21 (Reuters) - Abbvie Inc ::ABBVIE ANNOUNCES POSITIVE TOPLINE RESULTS FROM PHASE 3 STUDY EVALUATING INVESTIGATIONAL ELAGOLIX IN WOMEN WITH UTERINE FIBROIDS.PHASE 3 ELARIS UF-I STUDY (M12-815) OF ELAGOLIX MET ITS PRIMARY ENDPOINT.RESULTS DEMONSTRATED ELAGOLIX, IN COMBINATION WITH LOW-DOSE ADD-BACK THERAPY, REDUCED HEAVY MENSTRUAL BLEEDING COMPARED TO PLACEBO.PHASE 3 ELARIS UF-I STUDY ALSO MET ALL RANKED SECONDARY ENDPOINTS (P<0.001) AT MONTH SIX.  Full Article

Neurocrine Will File NDA For Opicapone For Parkinson's Disease Based On Existing Pivotal Clinical Trial Data
Wednesday, 14 Feb 2018 04:01pm EST 

Feb 14 (Reuters) - Neurocrine Biosciences Inc ::NEUROCRINE BIOSCIENCES WILL FILE NEW DRUG APPLICATION FOR OPICAPONE FOR PARKINSON'S DISEASE BASED ON EXISTING PIVOTAL CLINICAL TRIAL DATA.NEUROCRINE BIOSCIENCES INC - NEUROCRINE WILL PROCEED WITH PLANS TO FILE NDA FOR OPICAPONE DURING FIRST HALF OF 2019.NEUROCRINE BIOSCIENCES INC - U.S. FDA HAS PROVIDED GUIDANCE ON REGULATORY PATH FORWARD TO SUPPORT NDA FOR OPICAPONE.NEUROCRINE BIOSCIENCES INC - NEUROLOGY DIVISION OF FDA HAS NOT REQUESTED CO TO CONDUCT AN ADDITIONAL PHASE III STUDY FOR OPICAPONE PRIOR TO NDA FILING.  Full Article

Neurocrine Biosciences Reports Q4 Earnings Per Share $0.07
Tuesday, 13 Feb 2018 04:01pm EST 

Feb 13 (Reuters) - Neurocrine Biosciences Inc ::NEUROCRINE BIOSCIENCES REPORTS FOURTH QUARTER AND YEAR-END 2017 FINANCIAL RESULTS AND PROVIDES INVESTOR UPDATE FOR 2018.Q4 EARNINGS PER SHARE $0.07.Q4 REVENUE $94.5 MILLION.NEUROCRINE BIOSCIENCES- REVENUE MILESTONES UNDER ABBVIE AGREEMENT FOR 2018 EXPECTED TO BE $40 MILLION CONTINGENT ON FDA APPROVAL OF ELAGOLIX FOR ENDOMETRIOSIS.‍ONGOING OPERATING EXPENSES FOR 2018 SHOULD APPROXIMATE $365 MILLION TO $395 MILLION​.  Full Article

Neurocrine Biosciences appoints Matt Abernethy as CFO
Monday, 20 Nov 2017 04:01pm EST 

Nov 20 (Reuters) - Neurocrine Biosciences Inc ::Neurocrine Biosciences appoints Matt Abernethy as chief financial officer.Neurocrine Biosciences Inc - announced that Matt Abernethy is joining executive management team as chief financial officer​.  Full Article

Neurocrine Biosciences reports Q3 loss per share $0.13
Wednesday, 1 Nov 2017 04:01pm EDT 

Nov 1 (Reuters) - Neurocrine Biosciences Inc :Neurocrine Biosciences reports third quarter 2017 results.Q3 loss per share $0.13.Q3 earnings per share view $-0.49 -- Thomson Reuters I/B/E/S.Says net product sales of $45.8 million for three months ended September 30, 2017​.  Full Article

Abbvie receives U.S. FDA priority review for investigational Oral Treatment Elagolix
Friday, 27 Oct 2017 07:00am EDT 

Oct 27 (Reuters) - Abbvie Inc :Abbvie receives U.S. FDA priority review for Investigational Oral Treatment Elagolix for the management of Endometriosis with associated pain.Abbvie inc - ‍expects PDUFA date for FDA to complete its review will be in Q2 2018​.  Full Article

Neurocrine initiates Phase IIb clinical study of Ingrezza
Wednesday, 25 Oct 2017 04:01pm EDT 

Oct 25 (Reuters) - Neurocrine Biosciences Inc :Neurocrine initiates phase IIb clinical study of once-daily Ingrezza in children and adolescents with Tourette syndrome.Neurocrine Biosciences Inc - ‍top-line data from study is expected in late 2018​.  Full Article

Neurocrine granted FDA orphan drug designation for Valbenazine
Monday, 23 Oct 2017 04:57pm EDT 

Oct 23 (Reuters) - Neurocrine Biosciences Inc :Neurocrine granted FDA orphan drug designation for valbenazine for the treatment of pediatric patients with Tourette syndrome.  Full Article

Neurocrine Biosciences says David-Alexander Gros resigns as COO and interim CFO of co
Thursday, 19 Oct 2017 05:52pm EDT 

Oct 20 (Reuters) - Neurocrine Biosciences Inc :Neurocrine Biosciences Inc - ‍on Oct. 18, David-Alexander C. Gros resigned as president, COO and interim CFO of co, effective as of Oct. 19 - SEC filing.Neurocrine Biosciences Inc - ‍in connection with resignation of Gros, effective Oct. 19, Kevin C. Gorman​ was appointed as company's interim CFO.  Full Article

BRIEF-Neurocrine Biosciences Q1 Loss Per Share $0.47

* NEUROCRINE BIOSCIENCES REPORTS FIRST QUARTER 2018 FINANCIAL RESULTS