Key Developments: Daiichi Sankyo Co Ltd (4568.T)

4568.T on Tokyo Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Daiichi Sankyo Co Ltd Announces Result in a Phase 3 Study for the Treatment of Symptomatic VTE and Prevention of its Recurrence
Sunday, 1 Sep 2013 03:00am EDT 

Daiichi Sankyo Co Ltd announced results from the global phase 3 Hokusai-VTE study of 8,292 patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), or both. The study found that the investigational, oral, once-daily direct factor Xa-inhibitor edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin, following initial use of heparin in both arms, for the treatment and prevention of recurrent symptomatic venous thromboembolism (VTE). Once-daily edoxaban also demonstrated superiority compared to warfarin for the principal safety outcome of clinically relevant bleeding (the composite of major or clinically relevant non-major bleeding). Results from Hokusai-VTE were presented at the ESC Congress 2013 in Amsterdam and published online in the New England Journal of Medicine.  Full Article

Daiichi Sankyo Co Ltd Receives FDA Approval for Iron Deficiency Anemia Agent- Nikkan Kogyo
Monday, 5 Aug 2013 08:00pm EDT 

Nikkan Kogyo reported that Daiichi Sankyo Co Ltd has received U.S. Food and Drug Administration (FDA) approval for Injectafer, which is a parenteral iron replacement product used for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had an unsatisfactory response to oral iron. Injectafer is also indicated for iron deficiency anemia in adult patients with non-dialysis dependent chronic kidney disease (NND-CKD).  Full Article

R&I Affirms Daiichi Sankyo Co Ltd's Rating at "AA"; Rating Outlook Stable
Monday, 8 Jul 2013 02:00am EDT 

Rating and Investment Information, Inc. (R&I) announced that it has affirmed the rating on Daiichi Sankyo Co Ltd at "AA". The rating outlook is stable.  Full Article

Daiichi Sankyo Co Ltd's Subsidiary Submits NDA for Cell-Based Pandemic Flu Vaccine- Pharma Japan
Sunday, 30 Jun 2013 08:00pm EDT 

Pharma Japan reported that Daiichi Sankyo Co Ltd announced that its subsidiary Kitasato Daiichi Sankyo Vaccine has filed a new drug application (NDA) on June 19, 2013 for the cell-based pandemic influenza vaccine.  Full Article

Daiichi Sankyo Co Ltd to Apply for Delisting from Nagoya Stock Exchange
Friday, 26 Apr 2013 02:00am EDT 

Daiichi Sankyo Co Ltd announced that it has decided to apply for delisting its stock from the Nagoya Stock Exchange on May 8, 2013.  Full Article

Daiichi Sankyo Co Ltd and Ranbaxy Laboratories Ltd Launch Hybrid Business in Brazil- Newswire18
Tuesday, 16 Apr 2013 08:00pm EDT 

Newswire18 reported that Ranbaxy Laboratories Ltd announced that it has launched a hybrid business with Daiichi Sankyo Co Ltd in Brazil to expand business of both companies. Ranbaxy Laboratories will support Daiichi Sankyo's Brazil-based subsidiary, Daiichi Sankyo Brasil Farmaceutica Ltda, to enter the branded generics market in addition to its established business of providing innovative products.  Full Article

Daiichi Sankyo Co Ltd And Ranbaxy Laboratories Ltd Announce Intention To Integrate Business Operations In Thailand
Tuesday, 15 Jan 2013 10:05pm EST 

Daiichi Sankyo Co Ltd and Ranbaxy Laboratories Ltd announced their intention to integrate their business operations in Thailand, to leverage and maximize the synergies of the Hybrid Business Model, which is expected to commence business on April 1, 2013. Under this strategy, Daiichi Sankyo and Ranbaxy would integrate the management of Daiichi Sankyo's Thailand subsidiary, Daiichi Sankyo (Thailand) Ltd. (DSTH) and Ranbaxy's Thailand subsidiary, Ranbaxy Unichem Co., Ltd. (RUCL). the new representative of the proposed integrated entity will be, head Suthas Thongprasert, who presently heads DSTH.  Full Article

Daiichi Sankyo Co Ltd and ArQule, Inc. Announces Top-Line Results Of Phase 2 Trial With Tivantinib in Colorectal Cancer
Friday, 11 Jan 2013 07:30am EST 

Daiichi Sankyo Co Ltd and ArQule, Inc. announced top-line results of a randomized Phase 2 signal generation trial of tivantinib (ARQ 197) used in combination with irinotecan and cetuximab in patients with refractory or relapsed colorectal cancer (CRC). Although trial did not meet primary endpoint of Progression-Free Survival (PFS), analysis of patients enrolled (n=122) showed that median PFS was 8.3 months in the experimental arm (patients treated with irinotecan and cetuximab plus tivantinib) compared with 7.3 months in control arm (patients treated with irinotecan and cetuximab plus placebo) (hazard ratio = 0.85, 95% CI:0.55, 1.33). Objective Response Rate (ORR), a secondary endpoint, was 45% in the experimental arm versus 33% in control arm but was not statistically significant. The PFS results obtained in both control arm and the experimental arm were longer than expected compared to previously published historical norms. The 122 patients enrolled in this trial (US n=67;Russia n=39; Western Europe n=16) had unresectable CRC, progressed following first-line treatment and had tumors expressing wild-type form of the KRAS gene. The primary objective of trial was to assess contribution of tivantinib to irinotecan and cetuximab treatment regimen. The primary endpoint of study was PFS, and secondary objectives included OS and ORR. Patients were randomized to receive tivantinib, 360 milligrams twice daily, plus irinotecan and cetuximab, or placebo plus irinotecan and cetuximab.  Full Article

Daiichi Sankyo Co Ltd and Amplimmune Announce Strategic Alliance to Develop AMP-110 Therapy for Autoimmune Disease
Monday, 7 Jan 2013 08:39pm EST 

Daiichi Sankyo Co Ltd and Amplimmune, Inc. announced that they have entered into a broad strategic collaboration to develop a new therapeutic protein, AMP-110 (B7-H4 fusion protein). The collaboration will focus on development of AMP-110, a potential immune modulation therapy for autoimmune diseases. This first-in-class biologic works by blocking inflammatory T cell differentiation. The parties expect to initiate a Phase 1 clinical study for the compound for the treatment of an autoimmune disease indication in the first half of 2013. Under the terms of the agreement, Daiichi Sankyo will pay Amplimmune an undisclosed option fee and provide more than $50 million to reimburse past and planned research and development costs for AMP-110 including funding for future development through a Phase 2 (Proof of Concept Study, hereafter, POC study). Amplimmune also will be eligible to receive additional program milestone payments during the collaboration period. Through the POC study, Daiichi Sankyo will have an exclusive option to acquire the AMP-110 program.  Full Article

Daiichi Sankyo Co Ltd to Apply for Marketing Approval for Anti-influenza Agent Inavir-Chemical Daily
Sunday, 18 Nov 2012 07:00pm EST 

Chemical Daily reported that Daiichi Sankyo Co Ltd announced that is has submitted an application to Ministry of Health, Labor and Welfare, applying for the manufacturing and marketing approval of its anti-influenza agent inavir.  Full Article

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