Feb 1 (Reuters) - Alkermes Plc ::ALKERMES RECEIVES COMPLETE RESPONSE LETTER FROM U.S. FOOD AND DRUG ADMINISTRATION FOR ALKS 5461 NEW DRUG APPLICATION.ALKERMES PLC - CRL STATES THAT FDA IS UNABLE TO APPROVE ALKS 5461 NDA IN ITS PRESENT FORM.ALKERMES - FDA IS REQUESTING ADDITIONAL CLINICAL DATA TO PROVIDE SUBSTANTIAL EVIDENCE OF EFFECTIVENESS OF ALKS 5461 FOR ADJUNCTIVE TREATMENT OF MDD.ALKERMES PLC - PLANS TO MEET WITH FDA TO DISCUSS CONTENTS OF CRL AND POTENTIAL NEXT STEPS FOR ALKS 5461.
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Dec 17 (Reuters) - Biogen Inc ::ALKERMES AND BIOGEN ANNOUNCE SUBMISSION OF A NEW DRUG APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR DIROXIMEL FUMARATE IN MULTIPLE SCLEROSIS.BIOGEN INC - IF APPROVED, BIOGEN INTENDS TO MARKET DIROXIMEL FUMARATE UNDER BRAND NAME VUMERITY™.BIOGEN INC - VUMERITY™ NAME HAS BEEN CONDITIONALLY ACCEPTED BY FDA & WILL BE CONFIRMED UPON APPROVAL.
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Nov 29 (Reuters) - Alkermes Plc ::ALKERMES ANNOUNCES POSITIVE TOPLINE RESULTS FROM ENLIGHTEN-2 PHASE 3 STUDY OF ALKS 3831 IN PATIENTS WITH SCHIZOPHRENIA.ALKERMES PLC - COMPANY PLANS TO SUBMIT NEW DRUG APPLICATION (NDA) TO U.S. FOOD AND DRUG ADMINISTRATION (FDA) IN MID-2019.ALKERMES PLC - ALKS 3831 MET BOTH CO-PRIMARY ENDPOINTS, DEMONSTRATING A FAVORABLE WEIGHT PROFILE COMPARED TO OLANZAPINE.ALKERMES PLC - ALSO MET ITS PRE-SPECIFIED KEY SECONDARY ENDPOINT.ALKERMES PLC - MOST COMMON ADVERSE EVENTS REPORTED IN ALKS 3831 TREATMENT GROUP WERE WEIGHT GAIN, SOMNOLENCE AND DRY MOUTH.ALKERMES PLC - MOST COMMON ADVERSE EVENTS REPORTED IN OLANZAPINE TREATMENT GROUP WERE WEIGHT GAIN, SOMNOLENCE AND INCREASED APPETITE.ALKERMES PLC - SERIOUS ADVERSE EVENTS OCCURRED IN 3.6% OF ALKS 3831 PATIENTS AND 2.5% OF OLANZAPINE PATIENTS DURING TREATMENT PERIOD.ALKERMES PLC - FOR ALKS 3831 TREATMENT GROUP, WEIGHT STABILIZED AT WEEK 6 AND REMAINED FLAT FOR REST OF SIX-MONTH TREATMENT PERIOD.ALKERMES PLC - LATEST FINDINGS BUILD ON POSITIVE SAFETY AND EFFICACY PROFILE SEEN THROUGHOUT ENLIGHTEN DEVELOPMENT PROGRAM.
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Oct 29 (Reuters) - Alkermes Plc ::ALKERMES ANNOUNCES PUBLICATION OF PHASE 3 DATA FOR ALKS 5461 FOR ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER IN MOLECULAR PSYCHIATRY.ALKERMES PLC - ALKS 5461 DEMONSTRATED CONSISTENT PROFILE OF ANTIDEPRESSANT ACTIVITY, SAFETY AND TOLERABILITY IN TWO PHASE 3 STUDIES.ALKERMES PLC - NEW DRUG APPLICATION FOR ALKS 5461 CURRENTLY UNDER FDA REVIEW WITH TARGET ACTION DATE OF JAN. 31, 2019.
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Oct 23 (Reuters) - Alkermes Plc ::REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS.Q3 NON-GAAP EARNINGS PER SHARE $0.07.Q3 GAAP LOSS PER SHARE $0.22.Q3 REVENUE $248.7 MILLION VERSUS I/B/E/S VIEW $236.7 MILLION.Q3 EARNINGS PER SHARE VIEW $-0.08 -- THOMSON REUTERS I/B/E/S.SEES FY 2018 NON-GAAP EARNINGS PER SHARE $0.12 TO $0.31.SEES FY 2018 LOSS PER SHARE $1.16 TO $1.35.ALKERMES - SEES 2018 TOTAL REVENUE BETWEEN $1.015 BILLION TO $1.045 BILLION, UP FROM PRIOR EXPECTATION OF $975 MILLION TO $1.025 BILLION.EXPECTS 2018 CAPEX TO RANGE FROM $65 MILLION TO $75 MILLION, FROM PRIOR EXPECTATION IN RANGE OF $80 MILLION TO $90 MILLION.
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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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