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Otsuka Holdings Co Ltd (4578.T)

4578.T on Tokyo Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Astex Pharmaceuticals And Otsuka Announce Results Of The Phase 3 Astral-1 Study Of Guadecitabine In Treatment-Naïve AML Patients Ineligible To Receive Intense Induction Chemotherapy
Tuesday, 31 Jul 2018 

July 30 (Reuters) - ASTEX PHARMACEUTICALS ::ASTEX PHARMACEUTICALS AND OTSUKA ANNOUNCE RESULTS OF THE PHASE 3 ASTRAL-1 STUDY OF GUADECITABINE (SGI-110) IN TREATMENT-NAÏVE AML PATIENTS INELIGIBLE TO RECEIVE INTENSE INDUCTION CHEMOTHERAPY.ASTEX PHARMACEUTICALS - STUDY DID NOT MEET ITS CO-PRIMARY ENDPOINTS.ASTEX PHARMACEUTICALS SAYS CONTINUES TO FOCUS ON COMPLETING PHASE 3 ASTRAL-2 AND ASTRAL-3 STUDIES.  Full Article

Otsuka Holdings unit to fully acquire U.S.-based firm Visterra via unit for $430 mln
Thursday, 12 Jul 2018 

July 12 (Reuters) - Otsuka Holdings Co Ltd <4578.T>:Says wholly owned unit Otsuka Pharmaceutical Co., Ltd plans to fully acquire U.S.-based firm Visterra Inc via unit Otsuka America, Inc. in the third quarter for fiscal year 2018.Acquisition price is $430 million.  Full Article

Otsuka Medical Devices, Otsuka Holdings And Recor Medical Announce Signing Of Merger Agreement
Tuesday, 10 Jul 2018 

July 10 (Reuters) - Otsuka Holdings Co Ltd <4578.T>::OTSUKA MEDICAL DEVICES, OTSUKA HOLDINGS AND RECOR MEDICAL ANNOUNCE SIGNING OF MERGER AGREEMENT.MERGER AGREEMENT PURSUANT TO WHICH OTSUKA HOLDINGS WILL ACQUIRE REMAINING SHARES IN RECOR FROM ITS CURRENT HOLDERS.  Full Article

Otsuka Holdings unit and Lundbeck to start third phase 3 trial to evaluate brexpiprazole in treatment of agitation in patients with Alzheimer's disease
Thursday, 24 May 2018 

May 24 (Reuters) - Otsuka Holdings Co Ltd <4578.T>:Says co's unit Otsuka Pharmaceutical Co Ltd and Lundbeck announce that the two companies' third clinical phase 3 study ofbrexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer's type will commence in June.  Full Article

Otsuka's tolvaptan approved by U.S. FDA as first treatment to slow kidney function decline in adults at risk of rapidly progressing ADPKD
Wednesday, 25 Apr 2018 

April 25 (Reuters) - Otsuka Holdings Co Ltd <4578.T>:Says its unit Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the U.S. Food and Drug Administration (FDA) has approved JYNARQUE™ (tolvaptan) as the first drug treatment available to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).  Full Article

Otsuka's JYNARQUE Approved By FDA As First Treatment to Slow Kidney Function Decline
Wednesday, 25 Apr 2018 

April 24 (Reuters) - Otsuka Pharmaceutical::U.S. FDA APPROVED JYNARQUE AS DRUG TREATMENT TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS AT RISK OF RAPIDLY PROGRESSING ADPKD.  Full Article

Otsuka Pharmaceutical Says Co, X-Chem Have Signed Collaborative Research Agreement To Advance Discovery Process For New Otsuka Drug Compounds
Wednesday, 20 Dec 2017 

Dec 19 (Reuters) - Otsuka Holdings Co Ltd <4578.T>::OTSUKA PHARMACEUTICAL SAYS CO, X-CHEM INC HAVE SIGNED COLLABORATIVE RESEARCH AGREEMENT TO ADVANCE DISCOVERY PROCESS FOR NEW OTSUKA DRUG COMPOUNDS.  Full Article

GW Pharmaceuticals Reacquires Full Rights To Develop And Commercialize Sativex In U.S.
Wednesday, 13 Dec 2017 

Dec 13 (Reuters) - GW Pharmaceuticals Plc ::GW PHARMACEUTICALS REACQUIRES FULL RIGHTS TO DEVELOP AND COMMERCIALIZE SATIVEX® IN U.S..GW PHARMACEUTICALS - NOW REACQUIRED FULL OWNERSHIP OF DEVELOPMENT, COMMERCIALIZATION RIGHTS TO PRODUCT IN U.S. WITHOUT UPFRONT PAYMENT TO OTSUKA​.GW PHARMACEUTICALS - ‍AGREED TO MAKE CONTINGENT MILESTONE PAYMENTS TO OTSUKA, FIRST OF WHICH WOULD BECOME DUE UPON FDA APPROVAL OF SATIVEX​.GW PHARMACEUTICALS PLC - ‍TERMINATION OF PREVIOUS LICENSE AGREEMENT WITH OTSUKA PHARMACEUTICAL CO IN RELATION TO SATIVEX IN U.S.​.  Full Article

Otsuka Holdings to transfer medical device business to unit
Tuesday, 14 Nov 2017 

Nov 14 (Reuters) - Otsuka Holdings Co Ltd <4578.T>:Says co plans to transfer medical device business to co's wholly owned unit Otsuka Medical Devices Co Ltd, with effective date of Jan. 1, 2018.Says unit will issue 80,000 shares of its common stock to the co.  Full Article

FDA accepts Otsuka's resubmission to support a regulatory review of Tolvaptan in the treatment of ADPKD
Thursday, 9 Nov 2017 

Nov 9 (Reuters) - Otsuka Holdings Co Ltd <4578.T>:FDA accepts Otsuka's resubmission to support a regulatory review of Tolvaptan in the treatment of ADPKD.‍otsuka Pharmaceutical - FDA accepts Otsuka's resubmission to support a regulatory review of tolvaptan in treatment of adpkd​.Otsuka Holdings Co Ltd - ‍April 2018 is anticipated completion timing of FDA's review based on PDUFA timeline ​.  Full Article