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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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