July 2 (Reuters) - Alkermes Plc ::FDA APPROVES ARISTADA INITIO™ FOR THE INITIATION OF ARISTADA® FOR SCHIZOPHRENIA.ALKERMES PLC - ARISTADA INITIO IS EXPECTED TO BE AVAILABLE IN MID-JULY.
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June 6 (Reuters) - Alkermes Plc ::ALKERMES RECEIVES $50 MILLION PAYMENT FROM BIOGEN FOLLOWING REVIEW OF PRELIMINARY GASTROINTESTINAL TOLERABILITY DATA FROM THE ONGOING BIIB098 CLINICAL DEVELOPMENT PROGRAM.ALKERMES PLC - ALKERMES EXPECTS TO SUBMIT A NEW DRUG APPLICATION (NDA) FOR BIIB098 TO U.S. FOOD AND DRUG ADMINISTRATION (FDA) IN Q4 OF 2018.ALKERMES PLC - ALL OF PAYMENT WILL BE RECORDED AS LICENSE REVENUE IN ALKERMES' FINANCIAL RESULTS FOR QUARTER ENDING JUNE 30, 2018.ALKERMES - MAY ALSO RECEIVE $150 MILLION MILESTONE PAYMENT FROM BIOGEN UPON FDA APPROVAL, ON OR BEFORE DEC. 31, 2021, OF NDA FOR BIIB098.
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April 26 (Reuters) - Alkermes Plc ::REPORTS FIRST QUARTER 2018 FINANCIAL RESULTS.Q1 NON-GAAP LOSS PER SHARE $0.09.Q1 GAAP LOSS PER SHARE $0.40.Q1 REVENUE $225.2 MILLION VERSUS I/B/E/S VIEW $219.3 MILLION.Q1 EARNINGS PER SHARE VIEW $-0.07 -- THOMSON REUTERS I/B/E/S.SEES FY 2018 LOSS PER SHARE $1.35 TO $1.55.COMPANY CONTINUES TO EXPECT TOTAL REVENUES TO RANGE FROM $975 MILLION TO $1.025 BILLION FOR FY18.NOW EXPECTS SG&A EXPENSES TO RANGE FROM $515 MILLION TO $545 MILLION FOR 2018.NOW EXPECTS SHARE-BASED COMPENSATION OF APPROXIMATELY $120 MILLION FOR 2018.COMPANY NOW EXPECTS NON-GAAP BASIC AND DILUTED LOSS PER SHARE OF $0.06 TO A NON-GAAP DILUTED EARNINGS PER SHARE OF $0.12 FY18.CONTINUES TO EXPECT CAPITAL EXPENDITURES TO RANGE FROM $80 MILLION TO $90 MILLION FOR 2018.Q1 EARNINGS PER SHARE VIEW $-0.07, REVENUE VIEW $219.3 MILLION -- THOMSON REUTERS I/B/E/S.
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April 16 (Reuters) - Alkermes Plc ::ALKERMES ANNOUNCES FDA ACCEPTANCE FOR REVIEW OF NEW DRUG APPLICATION FOR ALKS 5461 FOR THE ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER.ALKERMES PLC - FDA ACTION EXPECTED BY JAN. 31, 2019.ALKERMES - ALKS 5461 NDA FILING BASED ON RESULTS FROM A CLINICAL EFFICACY AND SAFETY PACKAGE.
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Dec 5 (Reuters) - Alkermes Plc ::PRIMECAP MANAGEMENT CO REPORTS A 11.35 PCT PASSIVE STAKE IN ALKERMES PLC <<>> AS OF NOV 30 - SEC FILING.
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Nov 27 (Reuters) - Alkermes Plc ::ALKERMES PLC- NOW EXPECTS 2017 TOTAL REVENUES TO RANGE FROM $870 MILLION TO $900 MILLION - SEC FILING.ALKERMES PLC- NOW EXPECTS 2017 NON-GAAP DILUTED INCOME PER SHARE OF $0.03 TO $0.22.ALKERMES PLC - EXPECTS 2017 GAAP BASIC AND DILUTED LOSS PER SHARE OF $0.91 TO $1.10.
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Nov 16 (Reuters) - Alkermes Plc ::Alkermes’ New Drug Application for Investigational Product Designed for Initiation Onto ARISTADA® accepted for filing by U.S. FDA.Says FDA issued target action date for Aripiprazole Lauroxil Nanocrystal Dispersion NDA of June 30, 2018 under PDUFA.
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Oct 26 (Reuters) - Alkermes Plc :ALKERMES TO INITIATE NEW CLINICAL STUDY EVALUATING ARISTADA® AND INVEGA SUSTENNA® FOR THE TREATMENT OF SCHIZOPHRENIA.ALKERMES PLC - PHASE 3B STUDY WILL ASSESS INVESTIGATIONAL PRODUCT DESIGNED FOR INITIATION ONTO ARISTADA.ALKERMES PLC - EFFICACY AND SAFETY OF TWO-MONTH ARISTADA COMPARED TO MARKET LEADER INVEGA SUSTENNA WILL ALSO BE EVALUATED IN TRIAL.
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Oct 26 (Reuters) - Alkermes Plc ::ALKERMES PLC REPORTS THIRD QUARTER 2017 FINANCIAL RESULTS.Q3 TOTAL REVENUES INCREASED 21% YEAR-OVER-YEAR TO $217.4 MILLION.Q3 GAAP LOSS PER SHARE OF $0.24.Q3 NON-GAAP EARNINGS PER SHARE OF $0.03.COMPANY UPDATES FINANCIAL EXPECTATIONS FOR 2017.Q3 EARNINGS PER SHARE VIEW $-0.01, REVENUE VIEW $231.0 MILLION -- THOMSON REUTERS I/B/E/S.NOW EXPECTS 2017 TOTAL REVENUES TO RANGE FROM $850 MILLION TO $880 MILLION.NOW EXPECTS 2017 BASIC AND DILUTED LOSS PER SHARE OF $1.04 TO $1.23.NOW EXPECTS 2017 CAPITAL EXPENDITURES TO RANGE FROM $50 MILLION TO $60 MILLION, REDUCED FROM $70 MILLION TO $80 MILLION.FY2017 EARNINGS PER SHARE VIEW $-0.04, REVENUE VIEW $894.3 MILLION -- THOMSON REUTERS I/B/E/S.
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Aug 21 (Reuters) - Alkermes Plc : :Alkermes PLC- Initiates rolling submission of ALKS 5461 NDA to U.S. FDA; Expects to complete submission of NDA for medicine by year-end 2017.
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