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Astellas Pharma Inc (4503.T)

4503.T on Tokyo Stock Exchange

1,858JPY
16 Aug 2018
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Latest Key Developments (Source: Significant Developments)

Astellas Pharma Considering Sale Of Some Central And Eastern European Assets- Bloomberg
Wednesday, 18 Jul 2018 

July 18 (Reuters) - :ASTELLAS PHARMA IS CONSIDERING A SALE OF SOME CENTRAL AND EASTERN EUROPEAN ASSETS- BLOOMBERG,CITING SOURCES.  Full Article

FDA Approves XTANDI For Treating Men With Non-Metastatic Castration-Resistant Prostate Cancer
Friday, 13 Jul 2018 

July 13 (Reuters) - Astellas Pharma Inc <4503.T>::U.S. FDA APPROVES XTANDI® (ENZALUTAMIDE) FOR THE TREATMENT OF MEN WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).U.S. FDA APPROVES XTANDI® (ENZALUTAMIDE) FOR THE TREATMENT OF MEN WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).ASTELLAS PHARMA - U.S. FDA APPROVES XTANDI FOR TREATING MEN WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER BASED ON RESULTS FROM PHASE 3 PROSPER TRIAL.  Full Article

Seattle Genetics, Astellas Announce Progress In Enfortumab Vedotin Urothelial Cancer Clinical Development Program
Monday, 9 Jul 2018 

July 9 (Reuters) - Astellas Pharma Inc <4503.T>::SEATTLE GENETICS AND ASTELLAS ANNOUNCE PROGRESS IN ENFORTUMAB VEDOTIN UROTHELIAL CANCER CLINICAL DEVELOPMENT PROGRAM.SEATTLE GENETICS INC - ENROLLMENT OF EV-201 PIVOTAL TRIAL COHORT DESIGNED TO SUPPORT POTENTIAL EXPEDITED REGISTRATION PATHWAY IN U.S. COMPLETED.  Full Article

Astellas, Fibrogen Announce Topline Results From Japan Phase 3 Study Of Roxadustat
Thursday, 31 May 2018 

May 31 (Reuters) - Astellas Pharma Inc <4503.T>::ASTELLAS & FIBROGEN ANNOUNCE TOPLINE RESULTS FROM DOUBLE-BLIND JAPAN PHASE 3 STUDY FOR ROXADUSTAT IN HEMODIALYSIS CHRONIC KIDNEY DISEASE PATIENTS WITH ANEMIA.ASTELLAS PHARMA INC - FOURTH JAPAN PHASE 3 STUDY FOR ROXADUSTAT MET ITS PRIMARY ENDPOINT.ASTELLAS PHARMA INC - ROXADUSTAT WAS WELL TOLERATED IN STUDY.ASTELLAS PHARMA INC - SAFETY PROFILE OF ROXADUSTAT WAS CONSISTENT WITH THAT OBSERVED IN PREVIOUS STUDIES BOTH IN DIALYSIS AND NON-DIALYSIS PATIENTS.  Full Article

Astellas Pharma submits application for marketing approval of peficitinib for rheumatoid arthritis
Thursday, 31 May 2018 

May 31 (Reuters) - Astellas Pharma Inc <4503.T>:Says it has submitted an application for marketing approval of peficitinib hydrobromide for the treatment of rheumatoid arthritis (including prevention of structural joint damage) in patients who have an inadequate response to conventional therapy in Japan.  Full Article

Astellas Says To Buy Back Up To 100 Billion Yen Of Stock
Thursday, 31 May 2018 

May 31 (Reuters) - Astellas Pharma Inc <4503.T>::ASTELLAS SAYS TO BUY BACK UP TO 100 BILLION YEN OF STOCK.  Full Article

FDA Grants Priority Review To Astellas' New Drug Application For Gilteritinib
Tuesday, 29 May 2018 

May 29 (Reuters) - Astellas Pharma Inc <4503.T>::U.S. FDA GRANTS PRIORITY REVIEW TO ASTELLAS' NEW DRUG APPLICATION FOR GILTERITINIB FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML).ASTELLAS PHARMA INC - PRESCRIPTION DRUG USER FEE ACT (PDUFA) GOAL DATE FOR A DECISION BY FDA IS NOVEMBER 29, 2018 FOR GILTERITINIB.ASTELLAS - NDA BASED ON ONGOING PHASE 3 ADMIRAL TRIAL INVESTIGATING GILTERITINIB FOR TREATMENT OF ADULT PATIENTS WITH FLT3MUT+ RELAPSED/REFRACTORY AML.  Full Article

FDA grants priority review to Astellas’ NDA for Gilteritinib for treatment of adult patients with relapsed or refractory AML
Tuesday, 29 May 2018 

May 29(Reuters) - Astellas Pharma Inc <4503.T>:Says it announced today that the U.S. Food and Drug Administration (FDA) has accepted, with priority review, the company’s New Drug Application (NDA) for gilteritinib for the treatment of adult patients who have relapsed or refractory Acute Myeloid Leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.  Full Article

Astellas Pharma signs exclusive licensing agreement with Aquinox Pharmaceuticals
Thursday, 10 May 2018 

May 10(Reuters) - Astellas Pharma Inc <4503.T>:Says it signed an exclusive license agreement with Aquinox Pharmaceuticals, Inc <<>> for Japan and certain other countries in the Asia-Pacific region for Astellas to develop and commercialize rosiptor, Aquinox’s lead drug candidate, a first-in-class, once-daily oral treatment currently in Phase 3 clinical development for interstitial cystitis/bladder pain syndrome (IC/BPS) in North America and Europe.Under the agreement, Astellas will have the exclusive right to research, develop, and commercialize rosiptor for all human diseases and conditions in Japan and additional countries in the Asia-Pacific region.  Full Article

Aquinox And Astellas Announce Exclusive Licensing Agreement For Rosiptor In Asia-Pacific Region Including Japan
Thursday, 10 May 2018 

May 9 (Reuters) - Astellas Pharma Inc <4503.T>::AQUINOX AND ASTELLAS ANNOUNCE EXCLUSIVE LICENSING AGREEMENT FOR ROSIPTOR IN ASIA-PACIFIC REGION INCLUDING JAPAN.AQUINOX PHARMACEUTICALS SAYS AQUINOX TO RECEIVE $25 MILLION IN UPFRONT PAYMENT, POTENTIALLY OVER $100 MILLION IN ADDITIONAL MILESTONE PAYMENTS AND ROYALTIES.AQUINOX- ASTELLAS WILL HAVE EXCLUSIVE RIGHT TO RESEARCH, DEVELOP, COMMERCIALIZE ROSIPTOR FOR ALL HUMAN DISEASES AND CONDITIONS IN JAPAN, OTHER APAC COUNTRIES.  Full Article