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Alkermes Plc (ALKS.O)

ALKS.O on Nasdaq

50.15USD
22 Nov 2017
Change (% chg)

$0.79 (+1.59%)
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Volume
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Latest Key Developments (Source: Significant Developments)

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

Alkermes qtrly gaap loss per share $0.28
Thursday, 27 Jul 2017 07:00am EDT 

July 27 (Reuters) - Alkermes Plc ::Alkermes Plc reports second quarter 2017 financial results.Qtrly gaap loss per share $0.28.Qtrly non-gaap earnings per share of $0.01.Qtrly revenues increased 12% year-over-year to $218.8 million.Alkermes Plc says reiterates its financial expectations for 2017.  Full Article

Alkermes announces positive preliminary topline results
Thursday, 29 Jun 2017 04:00pm EDT 

June 29 (Reuters) - Alkermes Plc ::Alkermes announces positive preliminary topline results from phase 3 antipsychotic efficacy study of ALKS 3831 for treatment of schizophrenia.Alkermes announces positive preliminary topline results from phase 3 antipsychotic efficacy study of ALKS 3831 for treatment of schizophrenia.Alkermes Plc - study met prespecified primary endpoint.Alkermes - ALKS 3831 demonstrating statistically significant reductions from baseline in positive and negative syndrome scale scores versus placebo.Alkermes Plc - study also met its key secondary endpoint.Alkermes Plc - study met prespecified primary endpoint, with ALKS 3831.Alkermes - enlighten-2, six-month phase 3 study evaluating weight gain profile of olanzapine compared to ALKS 3831, is ongoing with data expected in 2018.Alkermes Plc - ALKS 3831 demonstrated statistically significant reductions from baseline in positive and negative syndrome scale scores compared to placebo.  Full Article

Alkermes announces initiation of study 217 for ALKS 5461
Monday, 12 Jun 2017 07:00am EDT 

June 12 (Reuters) - Alkermes Plc :Alkermes announces initiation of study 217 for ALKS 5461 for treatment of major depressive disorder.‍phase 3B study designed to further evaluate ALKS 5461's potential benefits on mood domains regulated by endogenous opioid modulation​.‍Company reiterates plans to submit new drug application to FDA by year-end 2017​.  Full Article

Alkermes says FDA approves two-month ARISTADA for treatment of schizophrenia
Tuesday, 6 Jun 2017 07:00am EDT 

June 6 (Reuters) - Alkermes plc ::FDA approves two-month ARISTADA® for treatment of schizophrenia.New two-month dose is expected to be available in mid-June.Says new two-month dose of ARISTADA is expected to be available in mid-June.  Full Article

Alkermes, certain subsidiaries enter into amendment to amended, restated credit agreement
Thursday, 13 Oct 2016 04:17pm EDT 

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

Alkermes submits supplemental new drug application to FDA
Monday, 8 Aug 2016 07:00am EDT 

Alkermes Plc : Alkermes submits supplemental new drug application to FDA for two month dosing option of Aristada® for treatment of schizophrenia . Notice of allowance issued for Aristada patent application, extending expected protection into 2035 .Expects patent to issue within next few months and expire no earlier than march 2035.  Full Article

BRIEF-Alkermes’ NDA for ARISTADA accepted for filing by U.S. FDA

* Alkermes’ New Drug Application for Investigational Product Designed for Initiation Onto ARISTADA® accepted for filing by U.S. FDA