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Astellas Pharma Inc (4503.T)

4503.T on Tokyo Stock Exchange

1,807JPY
14 Nov 2019
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Latest Key Developments (Source: Significant Developments)

Astellas Pharma Says Japan's Ministry Of Health, Labour And Welfare Approved Evrenzo(Roxadustat)
Friday, 20 Sep 2019 

Sept 20 (Reuters) - Astellas Pharma Inc <4503.T>::EVRENZO® (ROXADUSTAT) TABLETS APPROVED IN JAPAN FOR TREATMENT OF ANEMIA ASSOCIATED WITH CHRONIC KIDNEY DISEASE IN DIALYSIS PATIENTS.JAPAN'S MINISTRY OF HEALTH, LABOUR AND WELFARE APPROVED EVRENZO.APPROVAL IS BASED ON FOUR PHASE 3 STUDIES CONDUCTED IN CKD ANEMIA PATIENTS ON DIALYSIS IN JAPAN.PHASE 3 STUDIES DEMONSTRATED THAT ROXADUSTAT WAS EFFECTIVE AT RAISING HEMOGLOBIN AND THAT IT WAS WELL-TOLERATED.  Full Article

Seattle Genetics And Astellas Announce U.S. FDA Grants Priority Review For Enfortumab Vedotin Biologics License Application In Locally Advanced Or Metastatic Urothelial Cancer
Monday, 16 Sep 2019 

Sept 16 (Reuters) - Seattle Genetics Inc ::SEATTLE GENETICS AND ASTELLAS ANNOUNCE U.S. FDA GRANTS PRIORITY REVIEW FOR ENFORTUMAB VEDOTIN BIOLOGICS LICENSE APPLICATION IN LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER.SEATTLE GENETICS INC - FOOD & DRUG ADMINISTRATION SETS PRESCRIPTION DRUG USER FEE ACTION DATE FOR MARCH 15, 2020.  Full Article

Ironwood Pharmaceuticals To No Longer Be Responsible For Supply Of Linaclotide API To Astellas
Friday, 2 Aug 2019 

Aug 1 (Reuters) - Astellas Pharma Inc <4503.T>::IRONWOOD PHARMACEUTICALS INC - BEGINNING ON JANUARY 1, 2020, CO WILL NO LONGER BE RESPONSIBLE FOR SUPPLY OF LINACLOTIDE API TO ASTELLAS.IRONWOOD PHARMACEUTICALS INC - BEGINNING JAN 1, 2020 ASTELLAS WILL BE RESPONSIBLE FOR ITS OWN SUPPLY OF LINACLOTIDE API FOR SALE IN JAPAN.IRONWOOD PHARMACEUTICALS INC - ASTELLAS HAS COMMITTED TO PURCHASE CERTAIN QUANTITIES OF LINACLOTIDE API FROM CO IN CALENDAR YEAR 2019.IRONWOOD PHARMACEUTICALS INC - IN CONSIDERATION FOR FOREGOING RIGHTS, ASTELLAS WILL PAY IRONWOOD A NON-REFUNDABLE UPFRONT PAYMENT OF $10 MILLION.IRONWOOD - BEGINNING JAN 1, 2020, ASTELLAS TO PAY ROYALTIES TO CO AT RATES BEGINNING IN MID-SINGLE DIGIT PERCENT IN LIEU OF ROYALTY PAYMENT TERMS.IRONWOOD PHARMACEUTICALS INC - ROYALTY PAYMENTS WILL NOT BE DUE ON NET SALES OF PRODUCTS IN CALENDAR YEAR 2019.IRONWOOD - AS RESULT OF EXECUTION OF AMENDED AND RESTATED AGREEMENT, CO NOW EXPECTS TOTAL 2019 REVENUE FROM ASTELLAS TO BE APPROXIMATELY $55 MILLION.  Full Article

Astellas And Frequency Therapeutics Enter Into License Agreement For FX-322
Wednesday, 17 Jul 2019 

July 17 (Reuters) - Astellas Pharma Inc <4503.T>::ASTELLAS AND FREQUENCY THERAPEUTICS ENTER INTO LICENSE AGREEMENT FOR FX-322, A REGENERATIVE TREATMENT CANDIDATE FOR HEARING LOSS.ASTELLAS PHARMA - ASTELLAS WILL BE RESPONSIBLE FOR DEVELOPMENT AND COMMERCIALIZATION OF FX-322 OUTSIDE OF THE U.S..ASTELLAS PHARMA - AS PER LICENSE AGREEMENT, FREQUENCY WILL RECEIVE AN UPFRONT PAYMENT OF $80 MILLION.ASTELLAS PHARMA - AS PER LICENSE AGREEMENT, FREQUENCY MAY ALSO GET UP TO ADDITIONAL $545 MILLION BASED ON DEVELOPMENT & COMMERCIAL MILESTONES, ROYALTIES.ASTELLAS PHARMA - FREQUENCY WILL BE RESPONSIBLE FOR U.S. DEVELOPMENT AND COMMERCIALIZATION FOR FX-322.ASTELLAS PHARMA - FREQUENCY PLANS TO INITIATE PHASE 2A STUDY IN Q4 2019 FOR FX-322.ASTELLAS PHARMA - REFLECTED IMPACT FROM LICENSE AGREEMENT FOR FX-322 IN ITS FINANCIAL FORECASTS OF CURRENT FISCAL YEAR ENDING MARCH 31, 2020.  Full Article

Astellas And Seattle Genetics Announce Submission Of Biologics License Application To FDA
Tuesday, 16 Jul 2019 

July 16 (Reuters) - Seattle Genetics Inc ::ASTELLAS AND SEATTLE GENETICS ANNOUNCE SUBMISSION OF BIOLOGICS LICENSE APPLICATION TO FDA FOR ENFORTUMAB VEDOTIN FOR PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER.  Full Article

Seattle Genetics And Astellas Announce Submission Of Biologics License Application To FDA
Tuesday, 16 Jul 2019 

July 16 (Reuters) - Seattle Genetics Inc ::SEATTLE GENETICS AND ASTELLAS ANNOUNCE SUBMISSION OF BIOLOGICS LICENSE APPLICATION TO FDA FOR ENFORTUMAB VEDOTIN FOR PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER.  Full Article

Vect-Horus Announces Collaboration And Option Agreement With Astellas Pharma
Tuesday, 4 Jun 2019 

June 4 (Reuters) - VECT-HORUS ::VECT-HORUS ANNOUNCES COLLABORATION AND OPTION AGREEMENT WITH ASTELLAS PHARMA.VECT-HORUS ANNOUNCES COLLABORATION AND OPTION AGREEMENT WITH ASTELLAS PHARMA.VECT-HORUS - WILL USE ITS PROPRIETARY TECHNOLOGY VECTRANS TO TRANSPORT ASTELLAS' ANTIBODY TO BRAIN FOR TREATMENT OF CNS DISEASES.  Full Article

U.S. FDA Approves Supplemental New Drug Application Adding Overall Survival Data For Xospata
Thursday, 30 May 2019 

May 30 (Reuters) - Astellas Pharma Inc <4503.T>::U.S. FDA APPROVES SUPPLEMENTAL NEW DRUG APPLICATION ADDING OVERALL SURVIVAL DATA FOR XOSPATA® (GILTERITINIB).  Full Article

Xencor And Astellas Enter Collaboration For Novel Bispecific Antibody Program
Tuesday, 2 Apr 2019 

April 2 (Reuters) - Xencor: :XENCOR AND ASTELLAS ENTER COLLABORATION FOR NOVEL BISPECIFIC ANTIBODY PROGRAM.XENCOR INC - ASTELLAS TO RECEIVE EXCLUSIVE WORLDWIDE LICENSE TO POTENTIAL DRUG CANDIDATES.XENCOR INC - PARTNERS TO GENERATE NOVEL BISPECIFIC ANTIBODIES DIRECTED TOWARD AN ANTI-TUMOR TARGET IDENTIFIED BY ASTELLAS.XENCOR INC - WILL RECEIVE AN UPFRONT PAYMENT.XENCOR - ELIGIBLE TO RECEIVE DEVELOPMENT, REGULATORY, SALES MILESTONE PAYMENTS & HIGH-SINGLE DIGIT TO LOW-DOUBLE DIGIT PERCENT ROYALTIES ON NET SALES.  Full Article

Phase 3 ADMIRAL Trial Data Show XOSPATA Significantly Prolongs Overall Survival in Adult Patients with a form of leukemia
Monday, 1 Apr 2019 

April 1 (Reuters) - Astellas Pharma Inc <4503.T>::PHASE 3 ADMIRAL TRIAL DATA SHOW XOSPATA® (GILTERITINIB) SIGNIFICANTLY PROLONGS OVERALL SURVIVAL IN ADULT PATIENTS WITH FLT3 MUTATION-POSITIVE RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA COMPARED WITH SALVAGE CHEMOTHERAPY.ASTELLAS PHARMA - RESULTS SHOW PATIENTS TREATED WITH XOSPATA HAD SIGNIFICANTLY LONGER OS THAN THOSE WHO RECEIVED STANDARD SALVAGE CHEMOTHERAPY.  Full Article

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Seattle Genetics, Astellas drug rapidly shrinks tumors in bladder cancer study

An experimental drug developed by Seattle Genetics Inc and Astellas Pharma Inc led to significant, rapid tumor shrinkage in patients with advanced bladder cancer who had been previously treated with immunotherapy and chemotherapy in a midstage trial, according to data presented on Monday.