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Alkermes Plc (ALKS.OQ)

ALKS.OQ on NASDAQ Stock Exchange Global Select Market

22.08USD
19 Aug 2019
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Latest Key Developments (Source: Significant Developments)

Alkermes Announces Settlement With Amneal Over Vivitrol Patent Dispute
Monday, 29 Jul 2019 

July 29 (Reuters) - Alkermes Plc ::ALKERMES ANNOUNCES SETTLEMENT WITH AMNEAL OVER VIVITROL® PATENT DISPUTE.ALKERMES PLC - PATENT TRIAL AND APPEAL BOARD ORAL HEARING CANCELLED.ALKERMES PLC - ADDITIONAL TERMS OF AGREEMENT ARE CONFIDENTIAL.ALKERMES - ENTERED INTO SETTLEMENT WITH AMNEAL PHARMA TO RESOLVE AMNEAL'S INTER PARTES REVIEW PETITION CHALLENGING U.S. PATENT NUMBER 7,919,499.  Full Article

Alkermes Expands Planned New Drug Application For ALKS 3831 To Include Treatment Of Bipolar I Disorder
Monday, 15 Jul 2019 

July 15 (Reuters) - Alkermes Plc ::ALKERMES EXPANDS PLANNED NEW DRUG APPLICATION FOR ALKS 3831 TO INCLUDE TREATMENT OF BIPOLAR I DISORDER.ALKERMES PLC - PLANS TO SUBMIT NEW DRUG APPLICATION FOR SCHIZOPHRENIA AND BIPOLAR I DISORDER INDICATIONS IN Q4 OF 2019.ALKERMES PLC - ALKS 3831 NDA WILL INCLUDE DATA FROM COMPLETED ALKS 3831 ENLIGHTEN CLINICAL DEVELOPMENT PROGRAM.  Full Article

Alkermes Advances ALKS 4230 Into Monotherapy Expansion Phase Of Study In Patients With Renal Cell Carcinoma Or Melanoma
Wednesday, 12 Jun 2019 

June 12 (Reuters) - Alkermes Plc ::ALKERMES ADVANCES ALKS 4230 INTO MONOTHERAPY EXPANSION PHASE OF ARTISTRY-1 IN PATIENTS WITH RENAL CELL CARCINOMA OR MELANOMA.ALKERMES - INITIATION OF ONGOING STUDY FOLLOWS IDENTIFICATION OF 6 ΜG/KG/DAY ADMINISTERED INTRAVENOUSLY AS RECOMMENDED MONOTHERAPY DOSE OF ALKS 4230.ALKERMES PLC - MAXIMUM TOLERATED DOSE OF ALKS 4230 HAS NOT YET BEEN REACHED.ALKERMES PLC - DOSE-ESCALATION STAGE OF ARTISTRY-1 STUDY IS CONTINUING.  Full Article

Alkermes Reports Q1 GAAP Loss Per Share Of $0.62
Thursday, 25 Apr 2019 

April 25 (Reuters) - Alkermes Plc ::REPORTS FIRST QUARTER 2019 FINANCIAL RESULTS.Q1 NON-GAAP LOSS PER SHARE $0.17.Q1 GAAP LOSS PER SHARE $0.62.Q1 REVENUE $223.1 MILLION VERSUS REFINITIV IBES ESTIMATE OF $219.7 MILLION.Q1 EARNINGS PER SHARE ESTIMATE $-0.21 -- REFINITIV IBES DATA.COMPANY REITERATING FINANCIAL EXPECTATIONS FOR 2019.FY2019 EARNINGS PER SHARE VIEW $0.36, REVENUE VIEW $1.18 BILLION -- REFINITIV IBES DATA.  Full Article

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

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.