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Astellas Pharma Inc (4503.T)

4503.T on Tokyo Stock Exchange

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Latest Key Developments (Source: Significant Developments)

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

R&I affirms Astellas Pharma's rating at "AA" and says stable outlook-R&I
Wednesday, 20 Sep 2017 02:29am EDT 

Sept 20 (Reuters) - Astellas Pharma Inc <4503.T>:* Rating and Investment Information, Inc. (R&I) affirmed the company's rating at "AA"-R&I.* Rating outlook stable-R&I.  Full Article

Astellas Pharma and Pfizer say positive top-line results from phase 3 prosper trial of XTANDI (enzalutamide)
Thursday, 14 Sep 2017 05:17am EDT 

Sept 14 (Reuters) - Astellas Pharma Inc <4503.T>:Co and Pfizer Inc <<>> announced that the Phase 3 PROSPER trial evaluating XTANDI®(enzalutamide) plus androgen deprivation therapy (ADT) versus ADT alone in patients with non-metastatic (M0) CastrationResistant Prostate Cancer (CRPC) met its primary endpoint of improved metastasis-free survival (MFS) .The preliminary safety analysis of the PROSPER trial appears consistent with the safety profile of XTANDI in previous clinical trials.  Full Article

Pfizer, Astellas report positive top-line results from phase 3 PROSPER trial of XTANDI
Thursday, 14 Sep 2017 05:00am EDT 

Sept 14 (Reuters) - Pfizer Inc ::Pfizer and Astellas announce positive top-line results from phase 3 prosper trial of XTANDI (enzalutamide) in patients with non-metastatic castration-resistant prostate cancer.Phase 3 prosper trial met its primary endpoint​.Preliminary safety analysis of PROSPER trial appears consistent with safety profile of XTANDI in previous clinical trials​.In study of patients taking XTANDI who earlier received docetaxel, 1% of XTANDI patients versus 0.3% of placebo patients died from infections or sepsis​.In study of chemotherapy-naïve patients, 1 patient in each treatment group (0.1%) had an infection resulting in death​.In placebo-controlled patients taking XTANDI who earlier got docetaxel, grade 3 or higher adverse reactions reported among 47% of XTANDI patients​.In placebo-controlled study of chemotherapy-naïve patients, grade 3-4 adverse reactions were reported in 44% of XTANDI patients​.In bicalutamide-controlled study of chemotherapy-naïve patients, grade 3-4 adverse reactions were reported in 38.8% of XTANDI patients​.Hypertension occurred in 11% of xtandi patients and 4% of placebo patients in two placebo-controlled trials​.No patients experienced hypertensive crisis​.  Full Article

U.S. FDA accepts for review Astellas' supplemental NDA for mirabegron for use in combination with solifenacin succinate
Tuesday, 12 Sep 2017 10:01pm EDT 

Sept 12 (Reuters) - Astellas Pharma Inc <4503.T>:U.S. FDA accepts for review Astellas' supplemental New Drug Application for Mirabegron for use in combination with solifenacin succinate 5 mg for the treatment of overactive bladder.Anticipated Prescription Drug User Fee Act (PDUFA) goal date for a decision by FDA is April 28, 2018.  Full Article

Astellas Pharma submits application for approval of fidaxomicin for the treatment of infectious enteritis in Japan
Monday, 31 Jul 2017 02:38am EDT 

July 31 (Reuters) - Astellas Pharma Inc <4503.T>:* Says it has submitted an application for marketing approval of fidaxomicin for the treatment of infectious enteritis in Japan .  Full Article

U.S. FDA grants orphan-drug designation to Astellas
Thursday, 20 Jul 2017 08:00am EDT 

July 20 (Reuters) - Astellas Pharma Inc <4503.T>::U.S. FDA grants orphan-drug designation to Astellas for development of FLT3 inhibitor gilteritinib in acute myeloid leukemia.  Full Article

BRIEF-Astellas acquires Mitobridge under existing collaboration

* SAYS ‍MITOBRIDGE WILL BECOME A WHOLLY-OWNED SUBSIDIARY OF ASTELLAS FOLLOWING CLOSE OF ACQUISITION​ Source text for Eikon: Further company coverage: