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Alkermes Plc (ALKS.OQ)

ALKS.OQ on NASDAQ Stock Exchange Global Select Market

33.67USD
22 Apr 2019
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Latest Key Developments (Source: Significant Developments)

Alkermes Announces Positive Topline Results From Study Of ARISTADA And INVEGA Sustenna
Tuesday, 9 Apr 2019 

April 9 (Reuters) - Alkermes Plc ::ALKERMES ANNOUNCES POSITIVE TOPLINE RESULTS FROM STUDY OF ARISTADA AND INVEGA SUSTENNA FOR TREATMENT OF SCHIZOPHRENIA.ALKERMES SAYS ALPINE TRIAL SHOWED BOTH LONG-ACTING INJECTABLE MEDICATIONS EFFECTIVELY CONTROLLED SCHIZOPHRENIA SYMPTOMS THROUGHOUT SIX-MONTH STUDY.ALKERMES SAYS ARISTADA DEMONSTRATED SIGNIFICANT AND SIMILAR EFFICACY TO INVEGA SUSTENNA, WITH DIFFERENCES IN SAFETY AND TOLERABILITY PARAMETERS.ALKERMES SAYS ALPINE STUDY MET ITS PRE-SPECIFIED PRIMARY ENDPOINT.  Full Article

Alkermes Says Chief Operating Officer Jim Robinson Has Resigned And Will Leave Co, Effective April 19, 2019
Monday, 8 Apr 2019 

April 8 (Reuters) - Alkermes Plc ::ALKERMES ANNOUNCES DEPARTURE OF JIM ROBINSON.ALKERMES PLC - JIM ROBINSON, PRESIDENT AND CHIEF OPERATING OFFICER, HAS RESIGNED FROM HIS POSITION AND WILL LEAVE COMPANY, EFFECTIVE APRIL 19, 2019.  Full Article

Alkermes And Biogen Announce U.S. FDA Acceptance Of Diroximel Fumarate New Drug Application For Multiple Sclerosis
Monday, 25 Feb 2019 

Feb 25 (Reuters) - Biogen Inc ::ALKERMES AND BIOGEN ANNOUNCE U.S. FOOD AND DRUG ADMINISTRATION ACCEPTANCE OF DIROXIMEL FUMARATE NEW DRUG APPLICATION FOR MULTIPLE SCLEROSIS.BIOGEN INC - IF APPROVED, BIOGEN INTENDS TO MARKET DIROXIMEL FUMARATE UNDER BRAND NAME VUMERITY.BIOGEN INC - NDA HAS BEEN ASSIGNED A PDUFA (PRESCRIPTION DRUG USER FEE ACT) TARGET ACTION DATE IN Q4 OF 2019.BIOGEN INC - ALKERMES IS SEEKING APPROVAL OF DIROXIMEL FUMARATE UNDER 505(B)(2) REGULATORY PATHWAY, REFERENCING BIOGEN'S DIMETHYL FUMARATE DATA.  Full Article

Alkermes Receives Complete Response Letter From U.S. Food For ALKS 5461 New Drug Application
Friday, 1 Feb 2019 

Feb 1 (Reuters) - Alkermes Plc ::ALKERMES RECEIVES COMPLETE RESPONSE LETTER FROM U.S. FOOD AND DRUG ADMINISTRATION FOR ALKS 5461 NEW DRUG APPLICATION.ALKERMES PLC - CRL STATES THAT FDA IS UNABLE TO APPROVE ALKS 5461 NDA IN ITS PRESENT FORM.ALKERMES - FDA IS REQUESTING ADDITIONAL CLINICAL DATA TO PROVIDE SUBSTANTIAL EVIDENCE OF EFFECTIVENESS OF ALKS 5461 FOR ADJUNCTIVE TREATMENT OF MDD.ALKERMES PLC - PLANS TO MEET WITH FDA TO DISCUSS CONTENTS OF CRL AND POTENTIAL NEXT STEPS FOR ALKS 5461.  Full Article

Alkermes And Biogen Announce Submission Of A New Drug Application To FDA For Diroximel Fumarate In Multiple Sclerosis
Monday, 17 Dec 2018 

Dec 17 (Reuters) - Biogen Inc ::ALKERMES AND BIOGEN ANNOUNCE SUBMISSION OF A NEW DRUG APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR DIROXIMEL FUMARATE IN MULTIPLE SCLEROSIS.BIOGEN INC - IF APPROVED, BIOGEN INTENDS TO MARKET DIROXIMEL FUMARATE UNDER BRAND NAME VUMERITY™.BIOGEN INC - VUMERITY™ NAME HAS BEEN CONDITIONALLY ACCEPTED BY FDA & WILL BE CONFIRMED UPON APPROVAL.  Full Article

Alkermes Announces Positive Topline Results From ENLIGHTEN-2 Phase 3 Study Of ALKS 3831 In Patients With Schizophrenia
Thursday, 29 Nov 2018 

Nov 29 (Reuters) - Alkermes Plc ::ALKERMES ANNOUNCES POSITIVE TOPLINE RESULTS FROM ENLIGHTEN-2 PHASE 3 STUDY OF ALKS 3831 IN PATIENTS WITH SCHIZOPHRENIA.ALKERMES PLC - COMPANY PLANS TO SUBMIT NEW DRUG APPLICATION (NDA) TO U.S. FOOD AND DRUG ADMINISTRATION (FDA) IN MID-2019.ALKERMES PLC - ALKS 3831 MET BOTH CO-PRIMARY ENDPOINTS, DEMONSTRATING A FAVORABLE WEIGHT PROFILE COMPARED TO OLANZAPINE.ALKERMES PLC - ALSO MET ITS PRE-SPECIFIED KEY SECONDARY ENDPOINT.ALKERMES PLC - MOST COMMON ADVERSE EVENTS REPORTED IN ALKS 3831 TREATMENT GROUP WERE WEIGHT GAIN, SOMNOLENCE AND DRY MOUTH.ALKERMES PLC - MOST COMMON ADVERSE EVENTS REPORTED IN OLANZAPINE TREATMENT GROUP WERE WEIGHT GAIN, SOMNOLENCE AND INCREASED APPETITE.ALKERMES PLC - SERIOUS ADVERSE EVENTS OCCURRED IN 3.6% OF ALKS 3831 PATIENTS AND 2.5% OF OLANZAPINE PATIENTS DURING TREATMENT PERIOD.ALKERMES PLC - FOR ALKS 3831 TREATMENT GROUP, WEIGHT STABILIZED AT WEEK 6 AND REMAINED FLAT FOR REST OF SIX-MONTH TREATMENT PERIOD.ALKERMES PLC - LATEST FINDINGS BUILD ON POSITIVE SAFETY AND EFFICACY PROFILE SEEN THROUGHOUT ENLIGHTEN DEVELOPMENT PROGRAM.  Full Article

Alkermes Announces Publication Of Phase 3 Data For ALKS 5461
Monday, 29 Oct 2018 

Oct 29 (Reuters) - Alkermes Plc ::ALKERMES ANNOUNCES PUBLICATION OF PHASE 3 DATA FOR ALKS 5461 FOR ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER IN MOLECULAR PSYCHIATRY.ALKERMES PLC - ALKS 5461 DEMONSTRATED CONSISTENT PROFILE OF ANTIDEPRESSANT ACTIVITY, SAFETY AND TOLERABILITY IN TWO PHASE 3 STUDIES.ALKERMES PLC - NEW DRUG APPLICATION FOR ALKS 5461 CURRENTLY UNDER FDA REVIEW WITH TARGET ACTION DATE OF JAN. 31, 2019.  Full Article

Alkermes PLC Reports Q3 Non-GAAP Earnings Per Share $0.07
Tuesday, 23 Oct 2018 

Oct 23 (Reuters) - Alkermes Plc ::REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS.Q3 NON-GAAP EARNINGS PER SHARE $0.07.Q3 GAAP LOSS PER SHARE $0.22.Q3 REVENUE $248.7 MILLION VERSUS I/B/E/S VIEW $236.7 MILLION.Q3 EARNINGS PER SHARE VIEW $-0.08 -- THOMSON REUTERS I/B/E/S.SEES FY 2018 NON-GAAP EARNINGS PER SHARE $0.12 TO $0.31.SEES FY 2018 LOSS PER SHARE $1.16 TO $1.35.ALKERMES - SEES 2018 TOTAL REVENUE BETWEEN $1.015 BILLION TO $1.045 BILLION, UP FROM PRIOR EXPECTATION OF $975 MILLION TO $1.025 BILLION.EXPECTS 2018 CAPEX TO RANGE FROM $65 MILLION TO $75 MILLION, FROM PRIOR EXPECTATION IN RANGE OF $80 MILLION TO $90 MILLION.  Full Article

FDA Approves ARISTADA INITIO For Initiation Of Aristada® For Schizophrenia
Monday, 2 Jul 2018 

July 2 (Reuters) - Alkermes Plc ::FDA APPROVES ARISTADA INITIO™ FOR THE INITIATION OF ARISTADA® FOR SCHIZOPHRENIA.ALKERMES PLC - ARISTADA INITIO IS EXPECTED TO BE AVAILABLE IN MID-JULY.  Full Article

Alkermes Says Receives $50 Million Payment From Biogen
Wednesday, 6 Jun 2018 

June 6 (Reuters) - Alkermes Plc ::ALKERMES RECEIVES $50 MILLION PAYMENT FROM BIOGEN FOLLOWING REVIEW OF PRELIMINARY GASTROINTESTINAL TOLERABILITY DATA FROM THE ONGOING BIIB098 CLINICAL DEVELOPMENT PROGRAM.ALKERMES PLC - ALKERMES EXPECTS TO SUBMIT A NEW DRUG APPLICATION (NDA) FOR BIIB098 TO U.S. FOOD AND DRUG ADMINISTRATION (FDA) IN Q4 OF 2018.ALKERMES PLC - ALL OF PAYMENT WILL BE RECORDED AS LICENSE REVENUE IN ALKERMES' FINANCIAL RESULTS FOR QUARTER ENDING JUNE 30, 2018.ALKERMES - MAY ALSO RECEIVE $150 MILLION MILESTONE PAYMENT FROM BIOGEN UPON FDA APPROVAL, ON OR BEFORE DEC. 31, 2021, OF NDA FOR BIIB098.  Full Article

UPDATE 1-Alkermes says long-acting drugs could help schizophrenics stay on medication longer

April 9 Alkermes Plc said on Tuesday its long-acting injectable therapy for schizophrenia has helped reduce symptoms and can become an effective option for ensuring patients stay on medication even after being discharged from hospital.