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Daiichi Sankyo Co Ltd (4568.T)

4568.T on Tokyo Stock Exchange

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Latest Key Developments (Source: Significant Developments)

FDA Approves Daiichi Sankyo's Turalio For Treatment Of Select Patients With TGCT, A Rare And Debilitating Tumor
Saturday, 3 Aug 2019 

Aug 2 (Reuters) - Daiichi Sankyo Co Ltd <4568.T>::FDA APPROVES DAIICHI SANKYO'S TURALIO™ (PEXIDARTINIB) FOR THE TREATMENT OF SELECT PATIENTS WITH TGCT, A RARE AND DEBILITATING TUMOR.DAIICHI SANKYO- FDA APPROVES DAIICHI SANKYO'S TURALIO™ (PEXIDARTINIB) FOR TREATMENT OF SELECT PATIENTS WITH TGCT, A RARE AND DEBILITATING TUMOR.  Full Article

American Regent Announces Launch And Availability Of Selenious Acid Injection, USP
Wednesday, 10 Jul 2019 

July 10 (Reuters) - American Regent Inc::AMERICAN REGENT INC - ANNOUNCES LAUNCH AND AVAILABILITY OF SELENIOUS ACID INJECTION, USP; PRODUCT IS AVAILABLE FOR IMMEDIATE SHIPMENT.  Full Article

Daiichi Sankyo Provides Update on FDA Review of Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Friday, 21 Jun 2019 

June 21 (Reuters) - Daiichi Sankyo Co Ltd <4568.T>::DAIICHI SANKYO PROVIDES UPDATE ON FDA REVIEW OF QUIZARTINIB FOR THE TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY FLT3-ITD AML.DAIICHI SANKYO CO LTD - RECEIVED A COMPLETE RESPONSE LETTER (CRL) FROM U.S. FOOD AND DRUG ADMINISTRATION (FDA.DAIICHI SANKYO CO LTD - RECEIVED CRL FOR (NDA) OF QUIZARTINIB FOR TREATMENT OF ADULTS WITH RELAPSED/REFRACTORY FLT3-ITD ACUTE MYELOID LEUKEMIA (AML)..  Full Article

Daiichi Sankyo Co Ltd - Not True It Is Negotiating Sale Of Otc Drug Business
Thursday, 23 May 2019 

May 23 (Reuters) - Daiichi Sankyo Co Ltd <4568.T>::DAIICHI SANKYO CO LTD - NOT TRUE IT IS NEGOTIATING SALE OF OTC DRUG BUSINESS.  Full Article

Daiichi Sankyo Provides Update On Ongoing FDA Review For Quizartinib For Treatment Of Patients With Relapsed/Refractory FLT3-ITD AML
Thursday, 4 Apr 2019 

April 4 (Reuters) - Daiichi Sankyo Co Ltd <4568.T>::DAIICHI SANKYO PROVIDES UPDATE ON ONGOING FDA REVIEW FOR QUIZARTINIB FOR TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY FLT3-ITD AML.DAIICHI SANKYO CO LTD - NEW PRESCRIPTION DRUG USER FEE ACT (PDUFA) ACTION DATE IS AUGUST 25, 2019..DAIICHI SANKYO - FDA EXTENDED ACTION DATE TO ALLOW TIME TO REVIEW ADDITIONAL DATA SUBMITTED BY DAIICHI SANKYO IN ASSOCIATION WITH AN FDA REQUEST..  Full Article

Daiichi Sankyo Co - FDA Grants Priority Review For Co's New Drug Application For CSF1R Inhibitor Pexidartinib
Tuesday, 5 Feb 2019 

Feb 5 (Reuters) - Daiichi Sankyo Co Ltd <4568.T>::FDA GRANTS PRIORITY REVIEW FOR DAIICHI SANKYO'S NEW DRUG APPLICATION FOR CSF1R INHIBITOR PEXIDARTINIB FOR TREATMENT OF PATIENTS WITH TGCT, A RARE, DEBILITATING TUMOR.DAIICHI SANKYO CO LTD - FDA HAS DESIGNATED AUGUST 3, 2019 AS PDUFA ACTION DATE FOR APPLICATION.  Full Article

Daiichi Sankyo To Sell Daiichi Sankyo Propharma Takatsuki Plant To Taiyo Holdings
Thursday, 31 Jan 2019 

Jan 31 (Reuters) - Japan's Daiichi Sankyo Co Ltd <4568.T>::ANNOUNCES TRANSFER OF DAIICHI SANKYO PROPHARMA TAKATSUKI PLANT AND COMPANY SPLIT.TO SELL TAKATSUKI PLANT TO TAIYO HOLDINGS <<<4626.T>>> FOR 37.6 BILLION YEN.  Full Article

Esperion Announces Agreement with Daiichi Sankyo Europe to Commercialize Bempedoic Acid in Europe
Friday, 4 Jan 2019 

Jan 4 (Reuters) - Esperion Therapeutics Inc ::ESPERION ANNOUNCES AGREEMENT WITH DAIICHI SANKYO EUROPE (DSE) TO COMMERCIALIZE BEMPEDOIC ACID IN EUROPE.ESPERION TO RECEIVE $300 MILLION IN UPFRONT AND NEAR-TERM MILESTONES.ESPERION TO RECEIVE $300 MILLION IN UPFRONT AND NEAR-TERM MILESTONES.TO RECEIVE UP TO $900 MILLION IN TOTAL MILESTONES.FDA AND EMA LDL-C APPROVAL DECISIONS ARE EXPECTED DURING FIRST HALF OF 2020.ESPERION THERAPEUTICS -GLOBAL CARDIOVASCULAR OUTCOMES TRIAL OF BEMPEDOIC ACID, IS ONGOING, CARDIOVASCULAR RISK REDUCTION RESULTS EXPECTED DURING 2022.WILL GRANT DAIICHI SANKYO EUROPE EXCLUSIVE COMMERCIALIZATION RIGHTS TO COMMERCIALIZE BEMPEDOIC ACID IN EUROPE.ESPERION WILL RECEIVE AN UPFRONT CASH PAYMENT OF $150 MILLION AS WELL AS $150 MILLION UPON FIRST COMMERCIAL SALES IN TERRITORY.DAIICHI SANKYO EUROPE WILL BE RESPONSIBLE FOR COMMERCIALIZATION IN TERRITORIES.WILL RECEIVE SUBSTANTIAL TIERED ROYALTIES ON NET TERRITORY SALES.ENTERED INTO A LICENSING AGREEMENT WITH DAIICHI SANKYO EUROPE (DSE).  Full Article

Medical Developments International Enters Distribution & License Deal With Daiichi Sankyo
Monday, 8 Oct 2018 

Oct 8 (Reuters) - Daiichi Sankyo Co Ltd <4568.T>::ENTERS DISTRIBUTION AND LICENSE AGREEMENT WITH DAIICHI SANKYO FOR PENTHROX IN CHINA, THAILAND & VIETNAM.DAIICHI SANKYO WILL PAY CO UP TO US$32.5 MILLION.MVP WILL FUND APPROVAL PROCESS UP TO US$10 MILLION & WILL OWN INTELLECTUAL PROPERTY GENERATED FROM PROGRAM.CO & DAIICHI SANKYO TO ENTER AGREEMENT WITH EPS INTERNATIONAL HOLDINGS TO GET PENTHROX APPROVED FOR SALE IN CHINA.  Full Article

Daiichi Sankyo to reorganize Kitasato Daiichi Sankyo Vaccine into specialized manufacturing unit
Friday, 27 Apr 2018 

April 27 (Reuters) - Daiichi Sankyo Co Ltd <4568.T>:Says it plans to reorganize unit Kitasato Daiichi Sankyo Vaccine Co., Ltd. into a unit specializing in manufacturing, effective April 1, 2019.Says it will establish a Saitama-based wholly owned biotech unit in August.The manufacturing and production technology functions of Kitasato Daiichi Sankyo Vaccine will be transferred to the new unit on April 1, 2019 .The functions of Kitasato Daiichi Sankyo Vaccine other than manufacturing and production technologies (research and development, quality assurance, sales and etc.) and marketing approvals will be transferred to the co.Other details will be disclosed later.  Full Article

U.S. FDA approves Daiichi Sankyo's treatment for rare joint tumor

The U.S. Food and Drug Administration on Friday approved Daiichi Sankyo Co Ltd's treatment for adult patients with a type of rare, non-cancerous tumor affecting joints and limbs.