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Alkermes Plc (ALKS.OQ)

ALKS.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Alkermes Announces FDA Acceptance For Review Of New Drug Application For Alks 5461
Monday, 16 Apr 2018 

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.  Full Article

Primecap Management Co Reports A 11.35 Pct Passive Stake In Alkermes
Tuesday, 5 Dec 2017 

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 

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 

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 

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 

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 

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

Alkermes initiates phase 3 study of ALKS 3831 in young adult patients
Thursday, 8 Jun 2017 

June 8 (Reuters) - Alkermes PLC ::Alkermes announces initiation of phase 3 study of alks 3831 in young adult patients.All participants in double-blind portion of study will be eligible to continue in open-label safety study of ALKS 3831 for additional 24 months.  Full Article

Alkermes Q4 non-gaap earnings per share $0.15
Wednesday, 15 Feb 2017 

Alkermes Plc : Alkermes plc reports financial results for the year ended dec. 31, 2016 and provides financial expectations for 2017 . Q4 non-gaap earnings per share $0.15 . Q4 revenue $213.5 million versus i/b/e/s view $206.4 million . Sees fy 2017 loss per share $1.17 to $1.36 . Q4 gaap loss per share $0.14 . Q4 earnings per share view $0.04 -- Thomson Reuters I/B/E/S . Alkermes plc - sees fy total revenues to range from $870 million to $920 million . Alkermes plc - sees fy non-gaap financial measure to be in range of non-gaap net loss of $15 million to non-gaap net income of $15 million .Fy2017 earnings per share view $0.34, revenue view $904.7 million -- Thomson Reuters I/B/E/S.  Full Article

Alkermes, certain subsidiaries enter into amendment to amended, restated credit agreement
Thursday, 13 Oct 2016 

Alkermes Plc : Alkermes - On Oct. 12, co, certain other subsidiaries of company entered into an amendment to amended and restated credit agreement - SEC filing . Alkermes - Amendment amends credit agreement to extend maturity date of the about $286 million outstanding term loan by two years to September 25, 2021 Source: (http://bit.ly/2e5hN5b) Further company coverage: [ALKS.O] ((bangalore.newsroom@thomsonreuters.com;)).  Full Article

BRIEF-Alkermes Announces FDA Acceptance For Review Of New Drug Application For Alks 5461

* ALKERMES ANNOUNCES FDA ACCEPTANCE FOR REVIEW OF NEW DRUG APPLICATION FOR ALKS 5461 FOR THE ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER