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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)

Biogen, Eisai scrap Alzheimer's drug trials
Thursday, 21 Mar 2019 

March 21 (Reuters) - Biogen Inc ::BIOGEN AND EISAI TO DISCONTINUE PHASE 3 ENGAGE AND EMERGE TRIALS OF ADUCANUMAB IN ALZHEIMER’S DISEASE.BIOGEN INC - INDEPENDENT DATA MONITORING COMMITTEE ADVISES ADUCANUMAB UNLIKELY TO MEET PRIMARY ENDPOINTS, LEADING TO DECISION TO DISCONTINUE TRIALS.BIOGEN INC - DECISION TO STOP TRIALS IS BASED ON RESULTS OF A FUTILITY ANALYSIS CONDUCTED BY AN INDEPENDENT DATA MONITORING COMMITTEE.BIOGEN - AS PART OF THIS DECISION, EVOLVE PHASE 2 SAFETY STUDY AND LONG-TERM EXTENSION OF PRIME PHASE1B STUDY OF ADUCANUMAB WILL ALSO BE DISCONTINUED.BIOGEN INC - RESULTS INDICATED TRIALS WERE UNLIKELY TO MEET PRIMARY ENDPOINT UPON COMPLETION.BIOGEN INC - INITIATION OF ADUCANUMAB PHASE 3 SECONDARY PREVENTION TRIAL WILL BE ASSESSED WHILE DATA FROM ENGAGE AND EMERGE ARE FURTHER EVALUATED.BIOGEN INC - RECOMMENDATION TO STOP STUDIES WAS NOT BASED ON SAFETY CONCERNS..BIOGEN INC - EVOLVE PHASE 2 SAFETY STUDY AND LONG-TERM EXTENSION OF PRIME PHASE1B STUDY OF ADUCANUMAB WILL ALSO BE DISCONTINUED.BIOGEN AND EISAI TO DISCONTINUE PHASE 3 ENGAGE AND EMERGE TRIALS OF ADUCANUMAB IN ALZHEIMER'S DISEASE.  Full Article

Eisai Inc Says Eisai Co Ltd, Purdue Pharma Announced A NDA Has Been Submitted To U.S. FDA For Lemborexant
Tuesday, 15 Jan 2019 

Jan 15 (Reuters) - Eisai Co Ltd <4523.T>::EISAI INC SAYS EISAI CO LTD, PURDUE PHARMA LP ANNOUNCED A NDA HAS BEEN SUBMITTED TO U.S. FDA FOR LEMBOREXANT, SEEKING APPROVAL FOR TREATING INSOMNIA.  Full Article

Biogen And Eisai Reports Data From Long-Term Extension Phase 1b Study
Tuesday, 28 Aug 2018 

Aug 28 (Reuters) - Biogen Inc ::BIOGEN AND EISAI REPORT DATA FROM LONG-TERM EXTENSION PHASE 1B STUDY OF INVESTIGATIONAL ALZHEIMER’S DISEASE TREATMENT ADUCANUMAB.BIOGEN INC - THERE ARE SMALL PATIENT NUMBERS IN NEW ANALYSES.BIOGEN INC - RESULTS IN STUDY ARE "GENERALLY CONSISTENT" WITH PREVIOUS INTERIM ANALYSES.BIOGEN INC - THERE WERE NO CHANGES TO RISK-BENEFIT PROFILE OF ADUCANUMAB IN STUDY.BIOGEN - OF 185 PATIENTS DOSED WITH ADUCANUMAB IN PHASE 1B STUDY, 46 PATIENTS EXPERIENCED AMYLOID IMAGING ABNORMALITIES (ARIA)-E (EDEMA).BIOGEN INC - EIGHT PATIENTS EXPERIENCED MORE THAN ONE EPISODE OF ARIA-E IN STUDY.BIOGEN - MAJORITY OF ARIA EVENTS IN STUDY WERE TYPICALLY MILD RADIOGRAPHICALLY, CLINICALLY ASYMPTOMATIC AND RESOLVED OR STABILIZED WITHIN 4-12 WEEKS.  Full Article

Eisai And Merck Announce FDA Grants Breakthrough Therapy Designation
Tuesday, 31 Jul 2018 

July 31 (Reuters) - Merck & Co Inc ::EISAI AND MERCK ANNOUNCE FDA GRANTS BREAKTHROUGH THERAPY DESIGNATION FOR LENVIMA® (LENVATINIB) IN COMBINATION WITH KEYTRUDA® (PEMBROLIZUMAB) AS THERAPY FOR PREVIOUSLY TREATED PATIENTS WITH ADVANCED AND/OR METASTATIC NON-MSI-H/PMMR ENDOMETRIAL CARCINOMA.  Full Article

Eisai Receives FDA Priority Review Designation For Fycompa
Wednesday, 30 May 2018 

May 30 (Reuters) - Eisai Inc::EISAI RECEIVES FDA PRIORITY REVIEW DESIGNATION FOR FYCOMPA® (PERAMPANEL) CIII PEDIATRIC INDICATIONS SUPPLEMENTAL NEW DRUG APPLICATION (SNDA).  Full Article

Morphotek Announces Agreement To License Its Eribulin-Linker Payload To Bliss Biopharmaceutical Of China
Monday, 9 Apr 2018 

April 9 (Reuters) - Morphotek::LICENSED ITS ERIBULIN-LINKER PAYLOAD TO BLISS BIOPHARMACEUTICAL CO OF CHINA.LICENSING AGREEMENT WITH BLISSBIO INCLUDES UPFRONT PAYMENT, MILESTONES, SALES ROYALTY PAYMENTS, WHICH ARE UNDISCLOSED.BLISSBIO HAS EXCLUSIVITY OPTION TO EXPAND TERRITORY BEYOND CHINA & TO DEVELOP THERAPEUTIC ADCS TO 2 ADDITIONAL ONCOLOGY TARGETS.AGREEMENT GRANTS BLISSBIO EXCLUSIVE RIGHT TO USE ERIBULIN-LINKER PAYLOAD TO DEVELOP THERAPEUTIC ADC AGAINST ONCOLOGY TARGET FOR CHINA MARKET .  Full Article

Eisai Submits sNDA To FDA For Fycompa Pediatric Indications
Friday, 30 Mar 2018 

March 30 (Reuters) - Eisai Inc : :EISAI SUBMITS SUPPLEMENTAL NEW DRUG APPLICATION (SNDA) TO FDA FOR FYCOMPA® (PERAMPANEL) PEDIATRIC INDICATIONS.EISAI INC - SUBMISSION ALSO PROPOSES PEDIATRIC INDICATION FOR MONOTHERAPY, ADJUNCTIVE USE FOR PGTC SEIZURES IN CHILDREN WITH EPILEPSY.EISAI INC SAYS SNDA IS FOR BOTH FYCOMPA TABLET AND ORAL SUSPENSION FORMULATIONS.  Full Article

Nichi-Iko Pharmaceutical says business and capital alliance with Eisai
Wednesday, 28 Mar 2018 

March 28 (Reuters) - Nichi-Iko Pharmaceutical Co Ltd <4541.T>:Says it forms business and capital alliance with Eisai Co Ltd <<<4523.T>>>.Says two entities will mainly cooperate on generic drug business model reform, ecosystem construction and API application .Says it will acquire 100 percent stake in ELMED EISAI Co Ltd from Eisai Co Ltd, for 17.12 billion yen in total.Says it plans to complete stake acquisition on April 1, 2019 .  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

UPDATE 3-Merck raises full-year forecasts as vaccines power profit beat

April 30 Merck & Co Inc reported higher-than-expected first-quarter profit on Tuesday on increased demand for vaccines and cancer immunotherapy Keytruda, and the U.S. drugmaker raised its 2019 earnings and revenue forecasts.