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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)

R&I affirms Astellas Pharma's rating at "AA" and says stable outlook-R&I
2:29am 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

Cytokinetics reports baseline data from first cohort of phase 2 clinical trial of ck-2127107 in patients with SMA
Wednesday, 5 Jul 2017 07:30am EDT 

July 5 (Reuters) - Cytokinetics Inc ::Cytokinetics announces baseline data from first cohort of phase 2 clinical trial of ck-2127107 in patients with sma.Cytokinetics -screen failures in cohort 1 primarily due to hfmse score that was either too high in ambulatory patients or too low in non-ambulatory patients.Cytokinetics - there were no statistically significant differences otherwise in baseline demographics of enrolled patients compared to screen failures.Cytokinetics - screen failures in cohort 1 primarily due to hfmse score that was either too high in ambulatory patients or too low in non-ambulatory patients.  Full Article

Seattle Genetics, Astellas announce updated enfortumab vedotin phase 1 data in metastatic urothelial cancer ​
Monday, 5 Jun 2017 10:45am EDT 

June 5 (Reuters) - Astellas Pharma Inc <4503.T>::Trial evaluating enfortumab vedotin in combination with CPIs is also planned for later in the year​.Cos this year plan to initiate registrational monotherapy phase 2 trial for locally advanced/ MUC patients previously treated with CPI therapy.  Full Article

Astellas Pharma completes acquisition of Ogeda SA in Belgium
Tuesday, 16 May 2017 09:39pm EDT 

May 17(Reuters) - Astellas Pharma Inc <4503.T>:Says it has completed the acquisition of Ogeda SA, a drug discovery company located in Gosselies, Belgium, and Ogeda has become a wholly owned subsidiary of the company as of CET May 17.  Full Article

Astellas Pharma says transfer of 16 Long-Listed Products in Japan to LTL Pharma
Friday, 28 Apr 2017 02:54am EDT 

April 28 (Reuters) - Astellas Pharma Inc <4503.T>:* Says Astellas and LTL Pharma Co., Ltd.confirmed the relevant closing conditions are met on April 28 to allow the transfer of the assets related to Astellas’ 16 long-listed products in Japan to LTL Pharma.* Astellas and LTL Pharma have now satisfied the pre-agreed conditions to close the transaction, with Astellas having received 20.1 billion yen as a result.  Full Article

BRIEF-R&I affirms Astellas Pharma's rating at "AA" and says stable outlook-R&I

* Rating and Investment Information, Inc. (R&I) affirmed the company's rating at "AA"-R&I