Edition:
India

Alkermes Plc (ALKS.OQ)

ALKS.OQ on NASDAQ Stock Exchange Global Select Market

47.68USD
10:01pm IST
Change (% chg)

$-0.72 (-1.49%)
Prev Close
$48.40
Open
$48.27
Day's High
$48.27
Day's Low
$47.66
Volume
63,435
Avg. Vol
312,309
52-wk High
$63.40
52-wk Low
$46.65

Latest Key Developments (Source: Significant Developments)

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
Friday, 14 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

Alkermes submits supplemental new drug application to FDA
Monday, 8 Aug 2016 

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

Alkermes says U.S. District Court issued unambiguous opinion in favor of co, U.S. FDA - SEC filing
Friday, 29 Jul 2016 

Alkermes Plc: On July 28 U.S. District Court for District of Columbia issued unambiguous opinion in favor of co and U.S. FDA - SEC filing . U.S. District Court unambiguous opinion affirming in all respects FDA's decision to approve Aristada for treatment of schizophrenia .U.S. District Court unambiguous opinion also "denying action filed by Otsuka for declaratory and injunctive relief".  Full Article

Alkermes PLC gives FY 2016 guidance
Thursday, 25 Feb 2016 

Alkermes PLC:Expects FY 2016 total revenues to range from $700 million to $750 million.Expects FY 2016 GAAP net loss to be in range of $225 million to $255 million, or a basic and diluted loss per share of $1.48 to $1.68.Expects FY 2016 non-GAAP net loss to be in the range of $25 million to $55 million, and non-GAAP basic and diluted loss per share to be between $0.16 and $0.36.  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