Key Developments: Astellas Pharma Inc (4503.T)

4503.T on Tokyo Stock Exchange

17 Apr 2015
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Latest Key Developments (Source: Significant Developments)

Astellas Pharma and Medivation announce topline results from the Phase 2 STRIVE trial
Thursday, 2 Apr 2015 07:30pm EDT 

Astellas Pharma Inc:The company and Medivation announced topline results from the Phase 2 STRIVE trial comparing enzalutamide with bicalutamide in a study population of men with non-metastatic or metastatic castration-resistant prostate cancer.The study achieved its primary endpoint demonstrating a statistically significant increase in progression-free survival (PFS) for enzalutamide compared with bicalutamide (Hazard Ratio = 0.24; 95% Confidence Interval, 0.18-0.32; p<0.0001).Median PFS was 19.4 months in the enzalutamide group compared with 5.7 months in the bicalutamide group.  Full Article

Immuno-Biological Laboratories announces new joint research agreement with Astellas Pharma
Tuesday, 31 Mar 2015 04:15am EDT 

Immuno-Biological Laboratories Co Ltd:Says signed new joint research agreement with Astellas Pharma, to cooperate on commercialization of pharmaceutical products in which a fibrinogen as raw material.  Full Article

Astellas Pharma Inc receives FDA approval for CRESEMBA for treatment of invasive aspergillosis and invasive mucormycosis
Friday, 6 Mar 2015 04:44pm EST 

Astellas Pharma Inc:Says that U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for use of CRESEMB.Says prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis).These are life-threatening fungal infections predominantly occurring in immunocompromised patients.Safety and efficacy profile of CRESEMBA in patients with invasive aspergillosis and invasive mucormycosis was demonstrated based on data from the CRESEMBA development program.Safety and efficacy profile of CRESEMBA in patients with invasive aspergillosis was demonstrated based on data from two Phase 3 clinical trials in adult patients with invasive fungal infections.In the SECURE study (a study of 516 patients), CRESEMBA demonstrated non-inferiority to voriconazole on primary endpoint of all-cause mortality at day 42 for the treatment of adult patients with invasive aspergillosis or other filamentous fungi.All-cause mortality through Day 42 was 18.6 percent in the CRESEMBA treatment group and 20.2 pct in voriconazole treatment group.In SECURE study, overall safety profile for CRESEMBA demonstrated similar rates of mortality and non-fatal adverse events as the comparator, voriconazole.  Full Article

Astellas Pharma Inc and Immunomic Therapeutics announces exclusive license for jrc2-lamp-vax
Thursday, 29 Jan 2015 07:00pm EST 

Astellas Pharma Inc:Immunomic Therapeutics, Inc and the company have entered into an exclusive license agreement for Japan to develop and commercialize JRC2-LAMP-vax, Immunomic Therapeutics' vaccine designed to treat allergies induced by Japanese red cedar pollen.The companies expect to initiate a Phase 1 trial of JRC2-LAMP-vax in Japan as soon as it is ready.Under the agreement, Astellas is responsible for developing and commercializing JRC2-LAMP-vax in Japan, where Japanese red cedar pollinosis is endemic.Immunomic Therapeutics will receive $15 million upon the execution of the agreement.Immunomic Therapeutics potentially will also receive up to $55 million in total development and regulatory milestone and technology transfer payments, as well as tiered double-digit royalties on net sales of the product.Astellas will fund clinical trial development costs and supporting development expenses for Japan.Immunomic Therapeutics also granted Astellas an exclusive option to negotiate a license for additional LAMP-vax DNA vaccines to treat allergy indications other than Japanese red cedar pollinosis in Japan.  Full Article

Astellas Pharma announces result for phase two terrain trial of XTANDI
Thursday, 22 Jan 2015 06:00pm EST 

Astellas Pharma Inc:Announces positive result for phase two terrain trial of XTANDI, which is an androgen receptor inhibitor.The XTANDI is researched and developed by the company and Medivation Corporation.  Full Article

Astellas Pharma Inc announces FDA anti-infective drugs advisory committee recommends approval of CRESEMBA (isavuconazonium)
Thursday, 22 Jan 2015 02:43pm EST 

Astellas Pharma Inc:Says the FDA Anti-infective Drugs Advisory Committee voted unanimously to recommend approval of investigational once-daily intravenous and oral broad-spectrum CRESEMBA (isavuconazonium) for the treatment of invasive aspergillosis.Also says 8 to 2 with one abstention to recommend approval for treatment of invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients.  Full Article

Cytokinetics Inc and Astellas announce expansion of collaboration for development of CK-2127107 in spinal muscular atrophy and other neuromuscular indications
Tuesday, 23 Dec 2014 07:30am EST 

Cytokinetics Inc and Astellas Pharma Inc:Says amendment to their collaboration agreement focused on research, development and commercialization of skeletal muscle activators.Companies have been jointly conducting research and development activities with the objective to advance novel skeletal sarcomere targeted therapies for diseases and medical conditions associated with muscle weakness in non-neuromuscular indications.Says collaboration has been expanded to enable development of CK-2127107, fast skeletal troponin activator, in Spinal Muscular Atrophy (SMA) and potentially other neuromuscular indications.As companies have agreed, Cytokinetics will conduct Phase II clinical trial of CK-2127107 in patients with SMA, which is planned to begin in 2015.Says Cytokinetics and Astellas will jointly develop and may jointly commercialize CK-2127107 and other fast skeletal troponin activators in neuromuscular indications.Says companies have extended their joint research program focused on discovery of additional skeletal sarcomere activators through 2016.  Full Article

Astellas Pharma Inc announces end of license agreement with Janssen Biotech to develop and commercialize ASP015K
Monday, 1 Dec 2014 08:00pm EST 

Astellas Pharma Inc:Astellas Pharma Inc. (“Astellas”) announced that its license agreement with Janssen Biotech, Inc. to develop and commercialize ASP015K, Astellas’ oral Janus Kinase (JAK) inhibitor, will end effective Jan. 15, 2015.Says Janssen Biotech has exercised its right to terminate the license agreement, which was signed in 2012.Says upon the effective date of termination, Astellas will regain all rights granted to Janssen and Astellas is considering the future plan for ASP015K outside Japan.  Full Article

Dana-Farber Cancer Institute and Astellas Pharma Inc announces research collaboration
Tuesday, 4 Nov 2014 05:30am EST 

Astellas Pharma Inc:Dana-Farber Cancer Institute (Dana-Farber) and Astellas Pharma Inc. announces three-year collaboration to research and develop small molecule inhibitors of oncogenic K-Ras for the treatment of cancer, including lung cancer.K-Ras is the most commonly mutated oncogene in human cancers, with about 30 pct of all cancers harbouring activating rasmutations.Furthermore, cancers with a high prevalence of K-Ras mutations, such as lung cancer and pancreatic cancer, are difficult to treat and clinical outcomes are poor even with aggressive medical interventions.Despite more than 20 years of research by industry and academia, K-Ras has proven highly difficult to target and no effective therapy currently exists.  Full Article

Astellas Pharma Inc announces collaboration with Proteostasis Therapeutics
Tuesday, 4 Nov 2014 12:00am EST 

Astellas Pharma Inc:Announced collaboration for research, development and commercialization of therapies modulating the unfolded protein response, with Proteostasis Therapeutics, Inc.Says to research and develop therapeutic candidates that modulate the Unfolded Protein Response (UPR) through the use of Proteostasis Therapeutics’ proprietary “Disease Relevant Translation” (DRT) and “Proteostasis Network” platform.  Full Article


US FDA approves Astellas drug for invasive fungal infections

- U.S. health regulators on Friday approved Japanese drugmaker Astellas Pharma Inc's drug for the treatment of two rare, often fatal invasive fungal infections that target patients with blood cancers.

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