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Eisai Co Ltd (4523.T)

4523.T on Tokyo Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Eisai & Imbrium Therapeutics Reports U.S. FDA Accepts New Drug Application For Lemborexant For Treatment Of Insomnia
Monday, 11 Mar 2019 

March 11 (Reuters) - Eisai Co Ltd <4523.T>::EISAI AND IMBRIUM THERAPEUTICS ANNOUNCE U.S. FDA FILING ACCEPTANCE OF NEW DRUG APPLICATION FOR LEMBOREXANT FOR THE TREATMENT OF INSOMNIA.EISAI CO LTD - PDUFA DATE IS SET FOR DECEMBER 27, 2019.  Full Article

FDA Accepts Eisai's Supplemental New Drug Application To Update Labeling For Anti-Obesity Agent Belviq
Monday, 25 Feb 2019 

Feb 25 (Reuters) - Eisai Co Ltd <4523.T>::FDA ACCEPTS EISAI'S SUPPLEMENTAL NEW DRUG APPLICATION (SNDA) TO UPDATE THE LABELING FOR ANTI-OBESITY AGENT BELVIQ® (LORCASERIN HCL).EISAI INC - PROPOSED UPDATED LABEL FOR BELVIQ TO INCLUDE LONG-TERM EFFICACY AND SAFETY DATA FROM CAMELLIA-TIMI 61.  Full Article

Eisai Co Ltd Announces Results Of First Round Of Voluntary Retirement Program
Friday, 18 Jan 2019 

Eisai Co Ltd <4523.T>::EISAI CO LTD ANNOUNCES RESULTS OF FIRST ROUND OF VOLUNTARY RETIREMENT PROGRAM.  Full Article

Eisai And Biogen Announce Additional Data From The Phase II Clinical Trial Of Ban2401
Thursday, 25 Oct 2018 

Oct 25 (Reuters) - Biogen Inc ::EISAI AND BIOGEN ANNOUNCE PRESENTATION OF ADDITIONAL DATA FROM THE PHASE II CLINICAL TRIAL OF BAN2401 IN EARLY ALZHEIMER’S DISEASE AT THE 2018 CLINICAL TRIALS ON ALZHEIMER’S DISEASE (CTAD) CONFERENCE.EISAI AND BIOGEN ANNOUNCE PRESENTATION OF ADDITIONAL DATA FROM THE PHASE II CLINICAL TRIAL OF BAN2401 IN EARLY ALZHEIMER’S DISEASE AT THE 2018 CLINICAL TRIALS ON ALZHEIMER’S DISEASE (CTAD) CONFERENCE.BIOGEN INC - BAN2401 DEMONSTRATED AN ACCEPTABLE TOLERABILITY PROFILE THROUGH 18 MONTHS OF STUDY DRUG ADMINISTRATION.BIOGEN INC - EISAI AND BIOGEN ARE CURRENTLY DISCUSSING NEXT STEPS FOR BAN2401 WITH REGULATORY AUTHORITIES.BIOGEN INC - AN OPEN-LABEL EXTENSION FOR PATIENTS PREVIOUSLY ENROLLED IN STUDY 201 IS BEING PLANNED, WITH ENROLLMENT EXPECTED TO BEGIN THIS YEAR.BIOGEN - HIGHEST TREATMENT DOSE SHOWED STATISTICALLY SIGNIFICANT SLOWING OF CLINICAL DECLINE ON ADCOMS OF 30 PERCENT VERSUS PLACEBO AT 18 MONTHS.BIOGEN - FROM CONVENTIONAL ANALYSIS, HIGHEST TREATMENT DOSE DEMONSTRATED STATISTICALLY SIGNIFICANT REDUCTION IN BRAIN AMYLOID AT 18 MONTHS (P<0.0001).BIOGEN INC - BAN2401 DEMONSTRATED AN ACCEPTABLE TOLERABILITY PROFILE THROUGH 18 MONTHS OF STUDY DRUG ADMINISTRATION.  Full Article

Eisai says implementation of voluntary retirement program
Thursday, 25 Oct 2018 

Oct 25(Reuters) - Eisai Co Ltd <4523.T>:Says it resolved to offer a voluntary retirement program to eligible employees.Employees 45 or older who will have worked at Eisai for five consecutive years or more as of April 1, 2018.Says number of eligible applicants will be approximately 100 for the first round .Effective date of retirement will be on March 31, 2019 for the first round, March 31, 2020 for the second round and March 31, 2021 for the third round.Offering period from Dec. 11 to Dec. 21 for the first round, and the application periods for the second and third rounds will cover a similar period of time each fiscal year.  Full Article

Eisai Announces FDA Approval Of Fycompa
Friday, 28 Sep 2018 

Sept 28 (Reuters) - Eisai Co Ltd <4523.T>::EISAI ANNOUNCES FDA APPROVAL OF FYCOMPA® IN PEDIATRIC PATIENTS AS YOUNG AS 4 YEARS OLD FOR THE TREATMENT OF PARTIAL-ONSET SEIZURES.  Full Article

Eisai And Merck Announce China NMPA Approval Of Lenvima For Treatment Of Unresectable HCC
Wednesday, 5 Sep 2018 

Sept 5 (Reuters) - Eisai Co Ltd <4523.T>::EISAI AND MERCK ANNOUNCE CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) APPROVAL OF LENVIMA® (LENVATINIB) FOR TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC).MERCK & CO INC - APPROVAL WAS BASED ON RESULTS FROM REFLECT STUDY (STUDY 304), AN OPEN-LABEL, PHASE 3 TRIAL.  Full Article

Morphotek Announces FDA Acceptance Of IND For Cancer Treatment
Wednesday, 10 Jan 2018 

Jan 10 (Reuters) - Eisai Co Ltd <4523.T>::MORPHOTEK ANNOUNCES FDA ACCEPTANCE OF INVESTIGATIONAL NEW DRUG APPLICATION FOR NEXT-GENERATION FARLETUZUMAB ANTIBODY-DRUG CONJUGATE MORAB-202.MORPHOTEK - U.S. FDA ACCEPTED INVESTIGATIONAL NEW DRUG APPLICATION FOR MORAB-202.  Full Article

Eisai, Merck Receive Breakthrough Therapy Designation From FDA For Lenvima, Keytruda
Tuesday, 9 Jan 2018 

Jan 9 (Reuters) - Eisai Co Ltd <4523.T>::EISAI AND MERCK RECEIVE BREAKTHROUGH THERAPY DESIGNATION FROM FDA FOR LENVIMA® (LENVATINIB MESYLATE) AND KEYTRUDA® (PEMBROLIZUMAB) AS COMBINATION THERAPY FOR ADVANCED AND/OR METASTATIC RENAL CELL CARCINOMA.EISAI AND MERCK RECEIVE BREAKTHROUGH THERAPY DESIGNATION FROM FDA FOR LENVIMA® (LENVATINIB MESYLATE) AND KEYTRUDA® (PEMBROLIZUMAB) AS COMBINATION THERAPY FOR ADVANCED AND/OR METASTATIC RENAL CELL CARCINOMA.  Full Article

Albireo Announces Agreement With Healthcare Royalty Partners
Wednesday, 3 Jan 2018 

Jan 3 (Reuters) - Albireo Pharma Inc ::ALBIREO ANNOUNCES ROYALTY MONETIZATION AGREEMENT WITH HEALTHCARE ROYALTY PARTNERS FOR ELOBIXIBAT IN JAPAN.ALBIREO PHARMA INC - ‍ALBIREO SUBSIDIARY ELIGIBLE TO RECEIVE UP TO $60 MILLION UNDER AGREEMENT​.ALBIREO PHARMA INC - ‍DECISION ON JAPANESE NEW DRUG APPLICATION FOR ELOBIXIBAT EXPECTED IN FIRST HALF OF 2018​.ALBIREO PHARMA -HCR OBTAINS RIGHT TO RECEIVE ROYALTIES, SALES MILESTONES FOR ELOBIXIBAT IN JAPAN THAT MAY BE PAYABLE BY EA PHARMA, UP TO A THRESHOLD​.ALBIREO PHARMA INC - ‍ELOBIX HAS RETAINED ITS RIGHT TO RECEIVE A MILESTONE PAYMENT FROM EA PHARMA IF ELOBIXIBAT IS APPROVED BY MHLW​.ALBIREO PHARMA INC - ‍ IF SPECIFIED THRESHOLD IS REACHED, ELOBIX WILL AGAIN BECOME ELIGIBLE TO RECEIVE ROYALTIES AND SALES MILESTONES FOR ELOBIXIBAT.  Full Article

Biogen announces $5 billion buyback days after shelving Alzheimer's trials

Biogen Inc said on Monday it would buy back shares worth $5 billion (3.8 billion pounds), days after its stock slumped on the drugmaker's announcement to end two Alzheimer's disease trials.