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Astellas Pharma Inc (4503.T)

4503.T on Tokyo Stock Exchange

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20 Apr 2018
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Latest Key Developments (Source: Significant Developments)

U.S. FDA Grants Priority Review For Supplemental New Drug Application For Xtandi
Monday, 19 Mar 2018 04:15pm EDT 

March 19 (Reuters) - Astellas Pharma Inc <4503.T>::U.S. FDA GRANTS PRIORITY REVIEW FOR A SUPPLEMENTAL NEW DRUG APPLICATION (SNDA) FOR XTANDI® (ENZALUTAMIDE) IN NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).ASTELLAS PHARMA INC - ‍PRESCRIPTION DRUG USER FEE ACT (PDUFA) GOAL DATE ASSIGNED BY FDA IS JULY 2018​.  Full Article

Astellas acquires Universal Cells Inc
Tuesday, 13 Feb 2018 08:00pm EST 

Feb 13 (Reuters) - Astellas Pharma Inc <4503.T>::ASTELLAS ACQUIRES UNIVERSAL CELLS, INC..ASTELLAS WILL PAY UP TO $102.5 MILLION OF UPFRONT AND MILESTONES TO ACQUIRE 100 PERCENT OWNERSHIP OF UNIVERSAL CELLS.‍IMPACT OF TRANSACTION ON ASTELLAS' FINANCIAL RESULTS FOR FISCAL YEAR ENDING MARCH 31, 2018 WILL BE IMMATERIAL​.  Full Article

Astellas Pharma says top-line results for two phase 3 trials of Peficitinib in rheumatoid arthritis patients
Wednesday, 7 Feb 2018 08:40pm EST 

Feb 8 (Reuters) - Astellas Pharma Inc <4503.T>:Says it announced that the results of two phase 3 trials (RAJ3 and RAJ4 trials) on Peficitinib hydrobromide, an oral JAK inhibitor developed by the co, in rheumatoid arthritis patients with an inadequate response to existing therapy, demonstrated superiority over placebo regarding the two trials' primary endpoints.The safety analysis of these trial appears consistent with the safety profile of Peficitinib in previous clinical trials and no new safety signal was observed.  Full Article

Astellas Pharma to repurchase up to 2.1 pct shares
Tuesday, 30 Jan 2018 10:17pm EST 

Jan 31 (Reuters) - Astellas Pharma Inc <4503.T>:Says it will repurchase up to 42 million shares, representing 2.1 percent of outstanding.Says share repurchase price at up to 60 billion yen in total.Says repurchase period from Feb. 1 to March 23 .  Full Article

Astellas Says Cytomegalovirus Vaccine (ASP0113) Did Not Meet Its Primary Or Secondary Endpoints In Phase 3 Helios Clinical Trial​
Monday, 22 Jan 2018 03:00am EST 

Jan 22 (Reuters) - Astellas Pharma Inc <4503.T>::ASTELLAS AND VICAL ANNOUNCE TOP-LINE RESULTS FOR PHASE 3 TRIAL OF CYTOMEGALOVIRUS VACCINE ASP0113 IN HEMATOPOIETIC STEM CELL TRANSPLANT RECIPIENTS.ASTELLAS PHARMA INC SAYS ‍VACCINE WAS GENERALLY WELL TOLERATED, WITH INJECTION-SITE REACTIONS BEING MOST COMMONLY REPORTED ADVERSE EVENT​.ASTELLAS PHARMA - ASP0113 DID NOT MEET ITS PRIMARY OR SECONDARY ENDPOINTS IN PHASE 3 HELIOS CLINICAL TRIAL​.  Full Article

Astellas Pharma says application of marketing approval for blinatumomab in Japan
Monday, 8 Jan 2018 08:35pm EST 

Jan 9 (Reuters) - Astellas Pharma Inc <4503.T>:Says it announced that an application was submitted in Japan for the marketing authorization for bispecific CD19-directed CD3 T cell engager (BiTE®) antibody construct blinatumomab to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia.In Japan, blinatumomab is jointly developed by Amgen Astellas BioPharma and the co.  Full Article

Astellas acquires Mitobridge under existing collaboration
Thursday, 30 Nov 2017 07:00pm EST 

Nov 30 (Reuters) - Astellas Pharma Inc <4503.T>::ASTELLAS ACQUIRES MITOBRIDGE UNDER EXISTING COLLABORATION.SAYS ‍MITOBRIDGE WILL BECOME A WHOLLY-OWNED SUBSIDIARY OF ASTELLAS FOLLOWING CLOSE OF ACQUISITION​.  Full Article

Seattle Genetics, Astellas initiate phase 1b trial for Enfortumab Vedotin
Wednesday, 8 Nov 2017 08:00am EST 

Nov 8 (Reuters) - Seattle Genetics Inc :Seattle Genetics and Astellas initiate phase 1B trial of Enfortumab Vedotin in combination with immune checkpoint inhibitor therapies in locally advanced or metastatic urothelial cancer.Primary objective of trial is to assess safety and tolerability of Enfortumab Vedotin in combination with CPI therapy​.  Full Article

Astellas Pharma completes share repurchase
Tuesday, 31 Oct 2017 09:46pm EDT 

Nov 1 (Reuters) - Astellas Pharma Inc <4503.T>:Says it completed repurchase of 49.3 million shares of its common stock, for 70 billion yen in total, as of Oct. 31 .  Full Article

Seattle Genetics and Astellas initiate pivotal trial of enfortumab vedotin
Tuesday, 10 Oct 2017 08:00am EDT 

Oct 10 (Reuters) - Astellas Pharma Inc <4503.T>::Seattle Genetics and Astellas initiate pivotal trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer.Seattle Genetics Inc - ‍companies also plan to initiate a combination trial of enfortumab vedotin with CPI therapy in late 2017​.  Full Article

BRIEF-Astellas Announces Sale Of Certain Agensys Research Facilities To Kite, A Gilead Co

* ASTELLAS ANNOUNCES SALE OF CERTAIN AGENSYS RESEARCH FACILITIES TO KITE, A GILEAD COMPANY