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Alkermes Plc (ALKS.OQ)

ALKS.OQ on NASDAQ Stock Exchange Global Select Market

18.56USD
14 Aug 2020
Change (% chg)

$-0.25 (-1.33%)
Prev Close
$18.81
Open
$18.80
Day's High
$18.92
Day's Low
$18.50
Volume
213,265
Avg. Vol
633,712
52-wk High
$23.18
52-wk Low
$11.98

Latest Key Developments (Source: Significant Developments)

Alkermes Announces FDA Acceptance Of Alks 3831 NDA For Treatment Of Schizophrenia And Bipolar I Disorder
Tuesday, 28 Jan 2020 

Jan 28 (Reuters) - Alkermes Plc ::ALKERMES ANNOUNCES U.S. FOOD AND DRUG ADMINISTRATION ACCEPTANCE OF ALKS 3831 NEW DRUG APPLICATION FOR TREATMENT OF SCHIZOPHRENIA AND BIPOLAR I DISORDER.ALKERMES PLC - NDA HAS BEEN ASSIGNED A PRESCRIPTION DRUG USER FEE ACT TARGET ACTION DATE OF NOV. 15, 2020 FOR ALKS 3831.  Full Article

Alkermes Announces U.S. FDA Acceptance Of ALKS 3831 New Drug Application For Treatment Of Schizophrenia And Bipolar I Disorder
Tuesday, 28 Jan 2020 

Jan 28 (Reuters) - Alkermes Plc ::ALKERMES ANNOUNCES U.S. FOOD AND DRUG ADMINISTRATION ACCEPTANCE OF ALKS 3831 NEW DRUG APPLICATION FOR TREATMENT OF SCHIZOPHRENIA AND BIPOLAR I DISORDER.ALKERMES PLC - NDA HAS BEEN ASSIGNED A PDUFA TARGET ACTION DATE OF NOV. 15, 2020.  Full Article

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
Tuesday, 9 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
Saturday, 2 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