Feb 19 (Reuters) - Clovis Oncology Inc ::ALKERMES AND CLOVIS ONCOLOGY INITIATE RESEARCH COLLABORATION TO EXPLORE COMBINATION CANCER THERAPIES.CLOVIS ONCOLOGY- ALKERMES, CO TO EXAMINE COMBINATIONS OF ALKS 4230 WITH RUCAPARIB & ALKS 4230 WITH LUCITANIB IN MULTIPLE MODELS IN PRECLINICAL STUDIES.CLOVIS ONCOLOGY INC - COMPANIES WILL SHARE COSTS RELATED TO PRECLINICAL STUDIES.
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Feb 19 (Reuters) - Alkermes Plc ::ALKERMES AND CLOVIS ONCOLOGY INITIATE RESEARCH COLLABORATION TO EXPLORE COMBINATION CANCER THERAPIES.CLOVIS ONCOLOGY INC - COMBINATIONS OF ALKS 4230 WITH RUCAPARIB AND LUCITANIB TO BE EVALUATED IN MULTIPLE PRECLINICAL TUMOR MODELS.CLOVIS - COMPANIES WILL SHARE COSTS RELATED TO PRECLINICAL STUDIES, AND EACH WILL CONTRIBUTE THEIR RESPECTIVE COMPOUNDS TO RESEARCH COLLABORATION..
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Feb 14 (Reuters) - Alkermes Plc ::REPORTS FINANCIAL RESULTS FOR THE YEAR ENDED DEC. 31, 2018 AND PROVIDES FINANCIAL EXPECTATIONS FOR 2019.Q4 NON-GAAP EARNINGS PER SHARE $0.34.Q4 REVENUE $315.8 MILLION VERSUS REFINITIV IBES ESTIMATE OF $255.1 MILLION.Q4 EARNINGS PER SHARE ESTIMATE $-0.04 -- REFINITIV IBES DATA.SEES FY 2019 NON-GAAP EARNINGS PER SHARE $0.25 TO $0.43.SEES FY 2019 LOSS PER SHARE $0.87 TO $1.06.Q4 GAAP LOSS PER SHARE $0.06.FY2019 EARNINGS PER SHARE VIEW $0.56 -- REFINITIV IBES DATA.2019 NET SALES OF PROPRIETARY PRODUCTS EXPECTED TO GROW APPROXIMATELY 24%.SEES 2019 TOTAL REVENUES TO RANGE FROM $1.14 BILLION TO $1.19 BILLION.EXPECTS 2019 COST OF GOODS MANUFACTURED AND SOLD TO RANGE FROM $180 MILLION TO $190 MILLION.EXPECTS RESEARCH AND DEVELOPMENT EXPENSES TO RANGE FROM $450 MILLION TO $480 MILLION IN 2019.FY2019 REVENUE VIEW $1.10 BILLION -- REFINITIV IBES DATA.
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Dec 21 (Reuters) - Recro Pharma Inc ::RECRO PHARMA AMENDS IV MELOXICAM LICENSE AGREEMENT WITH ALKERMES.RECRO PHARMA INC - UNDER PRIOR AGREEMENT AS AMENDED, RECRO PHARMA OWED ALKERMES A MILESTONE PAYMENT OF $45 MILLION UPON APPROVAL OF IV MELOXICAM BY FDA.RECRO PHARMA INC - CURRENTLY AWAITING ITS ASSIGNED PDUFA GOAL DATE OF MARCH 24, 2019.RECRO PHARMA - AMENDMENT TO ITS GLOBAL LICENSING AGREEMENT WITH ALKERMES PHARMA IRELAND CONCERNING MILESTONE PAYMENTS FOR INTRAVENOUS MELOXICAM.RECRO PHARMA INC - AMENDMENT WILL REDUCE CASH REQUIREMENTS FOR 2019 BY APPROXIMATELY $30 MILLION AND EXTENDS PAYMENTS OVER A 7-YEAR PERIOD.RECRO PHARMA - NEWLY EXECUTED AMENDMENT PROVIDES THAT CO WILL NOW PAY TO ALKERMES $5 MILLION WITHIN 30 CALENDAR DAYS FOLLOWING AMENDMENT EFFECTIVE DATE.RECRO PHARMA - AMENDMENT PROVIDES THAT CO WILL NOW PAY TO ALKERMES $5 MILLION IN APRIL 2019, & $5 MILLION WITHIN 180 DAYS POST FDA APPROVAL OF IV MELOXICAM.RECRO PHARMA INC - A NEW DRUG APPLICATION (NDA) FOR IV MELOXICAM IS CURRENTLY UNDER REVIEW BY U.S. FOOD AND DRUG ADMINISTRATION (FDA).RECRO PHARMA - REGARDING AMENDMENT, WILL ALSO REPRICE ORIGINAL WARRANTS ISSUED TO ALKERMES AT MARKET PRICING PLUS 20% PREMIUM, AT STRIKE PRICE OF $8.26.
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April 2 (Reuters) - Alkermes Plc ::ALKERMES RECEIVES REFUSAL TO FILE LETTER FROM FDA FOR ALKS 5461.ALKERMES PLC SAYS "STRONGLY DISAGREES WITH FDA'S CONCLUSIONS AND PLANS TO APPEAL FDA'S DECISION".UPON ITS PRELIMINARY REVIEW, FDA HAS TAKEN POSITION THAT IT IS UNABLE TO COMPLETE A SUBSTANTIVE REVIEW OF REGULATORY PACKAGE.FDA REQUESTED CONDUCT OF BIOAVAILABILITY STUDY TO GENERATE ADDITIONAL BRIDGING DATA BETWEEN ALKS 5461 & REFERENCE LISTED DRUG, BUPRENORPHINE.INTENDS TO SEEK IMMEDIATE GUIDANCE, INCLUDING REQUESTING A TYPE A MEETING WITH FDA TO DETERMINE NEXT STEPS REQUIRED TO RESUBMIT NDA.ISSUED FINANCIAL GUIDANCE FOR 2018.
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March 29 (Reuters) - Alkermes Plc ::ALKERMES PLC SAYS ON MARCH 26, CO ,UNITS ENTERED AMENDMENT TO AMENDED & RESTATED CREDIT AGREEMENT, DATED AS OF SEPTEMBER 16, 2011 - SEC FILING.ALKERMES SAYS AMENDMENT PROVIDES FOR NEW CLASS OF REPLACEMENT TERM LOANS OF $284.3 MILLION MATURING ON MARCH 26, 2023 - SEC FILING.ALKERMES PLC - PROCEEDS OF NEW TERM LOAN FACILITY USED TO REFINANCE IN FULL BORROWER'S $284.3 MILLION IN TERM LOANS MATURING 2021.ALKERMES PLC - AMENDMENT TO AGREEMENT PROVIDES $175 MILLION INCREMENTAL CAPACITY PLUS ADDITIONAL AMOUNTS SO LONG AS CO MEETS CERTAIN CONDITIONS.
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Feb 14 (Reuters) - Alkermes Plc ::REPORTS FINANCIAL RESULTS FOR THE YEAR ENDED DEC. 31, 2017 AND PROVIDES FINANCIAL EXPECTATIONS FOR 2018.Q4 NON-GAAP EARNINGS PER SHARE $0.31.Q4 REVENUE $275.4 MILLION.SEES FY 2018 NON-GAAP LOSS PER SHARE $0.03 TO $0.23.SEES FY 2018 LOSS PER SHARE $1.61 TO $1.81.Q4 GAAP LOSS PER SHARE $0.06.COMPANY EXPECTS TOTAL REVENUES TO RANGE FROM $975 MILLION TO $1.025 BILLION IN 2018.COMPANY EXPECTS CAPITAL EXPENDITURES TO RANGE FROM $80 MILLION TO $90 MILLION IN 2018.Q4 EARNINGS PER SHARE VIEW $0.23, REVENUE VIEW $252.9 MILLION -- THOMSON REUTERS I/B/E/S.FY2018 REVENUE VIEW $999.2 MILLION -- THOMSON REUTERS I/B/E/S.
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Jan 31 (Reuters) - Alkermes Plc ::ALKERMES SUBMITS NEW DRUG APPLICATION TO U.S. FDA FOR ALKS 5461 FOR THE ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER.
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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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