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Alkermes Plc (ALKS.OQ)

ALKS.OQ on NASDAQ Stock Exchange Global Select Market

44.07USD
25 Apr 2018
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Latest Key Developments (Source: Significant Developments)

Alkermes Receives Refusal To File Letter From FDA For ALKS 5461
Monday, 2 Apr 2018 07:00am EDT 

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.  Full Article

Alkermes Says Co, Units Entered Amendment To Amended And Restated Credit Agreement
Thursday, 29 Mar 2018 05:14pm EDT 

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.  Full Article

Alkermes PLC Reports Q4 Non-Gaap Earnings Per Share $0.31
Wednesday, 14 Feb 2018 07:00am EST 

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.  Full Article

Alkermes Submits NDA To U.S. FDA For ALKS 5461 FOR ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER
Wednesday, 31 Jan 2018 02:01pm EST 

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.  Full Article

Primecap Management Co Reports A 11.35 Pct Passive Stake In Alkermes
Tuesday, 5 Dec 2017 12:08pm EST 

Dec 5 (Reuters) - Alkermes Plc ::PRIMECAP MANAGEMENT CO REPORTS A 11.35 PCT PASSIVE STAKE IN ALKERMES PLC <<>> AS OF NOV 30 - SEC FILING.  Full Article

Alkermes Expects 2017 Non-GAAP Income Of $0.03 To $0.22/Shr
Monday, 27 Nov 2017 07:23am EST 

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​.  Full Article

Alkermes’ NDA for ARISTADA accepted for filing by U.S. FDA
Thursday, 16 Nov 2017 07:00am EST 

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.  Full Article

ALKERMES INITIATES CLINICAL STUDY EVALUATING ARISTADA, INVEGA SUSTENNA FOR SCHIZOPHRENIA
Thursday, 26 Oct 2017 07:02am EDT 

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​.  Full Article

ALKERMES PLC REPORTS ‍Q3 GAAP LOSS PER SHARE OF $0.24
Thursday, 26 Oct 2017 07:00am EDT 

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.  Full Article

Alkermes PLC says ‍initiates rolling submission of ALKS 5461 NDA to U.S. FDA
Monday, 21 Aug 2017 07:00am EDT 

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​.  Full Article

BRIEF-Alkermes Q1 GAAP Loss Per Share $0.40

* Q1 REVENUE $225.2 MILLION VERSUS I/B/E/S VIEW $219.3 MILLION