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45680

Daiichi Sankyo Co., Ltd.
GICS: Health Care · SECTOR: EQTY · SUB-SECTOR: - · THEMEFOLIO: $HLTH
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Daiichi Sankyo Co., Ltd.
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JP3475350009
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45680
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4568.T
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4568 JP
Do., 11.09.2025       Daiichi Sankyo

The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU® (trastuzumab deruxtecan) for the treatment of adult patients with HER2 positive (immunohistochemistry [IHC] 3+) unresectable or metastatic solid tumors who have received prior treatment and have no satisfactory alternative treat...
Do., 14.08.2025       Daiichi Sankyo

Daiichi Sankyo (TSE: 4568) will present new clinical research across its DXd antibody drug conjugate (ADC) portfolio in lung cancer at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25). Data at WCLC will showcase the company’s progress towards creating new standards of c...
Do., 17.07.2025       Daiichi Sankyo

ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered b...
Mi., 09.07.2025       Daiichi Sankyo

Final long-term efficacy and safety results from the open-label extension of the ENLIVEN phase 3 trial showed a sustained clinical benefit from long-term treatment with TURALIO® (pexidartinib) in patients with symptomatic tenosynovial giant cell tumor (TGCT) not amenable to improvement with surgery. These results, consistent with the primary analy...
Mo., 23.06.2025       Daiichi Sankyo

DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective respon...
Mo., 16.06.2025       Daiichi Sankyo

After ENHERTU®, VANFLYTA® is the second innovative medicine from the Daiichi Sankyo oncology pipeline to be available in CanadaApproval based on QuANTUM-First results demonstrating VANFLYTA added to chemotherapy improved overall survival...
Mo., 09.06.2025       Daiichi Sankyo

The first patient has been dosed in the DESTINY-Endometrial01 phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) in combination with rilvegostomig or pembrolizumab versus platinum-based chemotherapy (carboplatin and paclitaxel) in combination with pembrolizumab as a first-line therapy in patients with HER2 expressing (IHC 3+/ 2+), mismatch...
Mo., 02.06.2025       Daiichi Sankyo

Positive results from the DESTINY-Breast09 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment in patients with HER2 positive meta...
So., 01.06.2025       Daiichi Sankyo

Results from three trials continue to demonstrate the potential of DATROWAY® (datopotamab deruxtecan) in combination with various immunotherapies to improve outcomes in patients with non-small cell lung cancer (NSCLC) across multiple stages of the disease. These results from TROPION-Lung02, TROPION-Lung04 and NeoCOAST-2 were presented at the 2025...
Sa., 31.05.2025       Daiichi Sankyo

Positive results from the DESTINY-Gastric04 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to ramucirumab plus paclitaxel in patients with second-line HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric...
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Do., 22.05.2025       Daiichi Sankyo

Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 20 abstracts in multiple cancers at the 2025 American Society of Clinical Oncology Scientific Program (#ASCO25). Data at ASCO showcasing the company’s progress towards creating new standards of care for patients with cancer will include two...
Mi., 07.05.2025       Daiichi Sankyo

Positive topline results from the DESTINY-Breast11 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) rate versus standard of care (dose-dense doxorubicin and cyclophospha...
Mo., 21.04.2025       Daiichi Sankyo

Positive topline results from a planned interim analysis of the DESTINY-Breast09 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) in combination with pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a fir...
Di., 08.04.2025       Daiichi Sankyo

DATROWAY® (datopotamab deruxtecan) has been approved in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. DATROWAY i...
Fr., 04.04.2025       Daiichi Sankyo

Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU® (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breas...
Mo., 31.03.2025       Daiichi Sankyo

The first patient has been dosed in the DESTINY-Gastric05 phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) in combination with a fluoropyrimidine chemotherapy (5-FU or capecitabine) and Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) versus trastuzumab in combination with platinum-based che...
Mo., 03.03.2025       Daiichi Sankyo

Positive topline results from the DESTINY-Gastric04 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) compared to ramucirumab and paclitaxel in patients with second-line HER2 positive (IHC 3+ or IHC 2+/ISH+) unresect...
Fr., 28.02.2025       Daiichi Sankyo

Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane...
Di., 04.02.2025       Daiichi Sankyo

A new survey sponsored by Daiichi Sankyo and AstraZeneca reveals that there is a need for more readily available information on breast cancer, with results revealing misconceptions and a lack of public awareness. The survey conducted across the major five European countries with 7,750 respondents found varying levels of public knowledge about brea...
Fr., 31.01.2025       Daiichi Sankyo

Datopotamab deruxtecan (Dato-DXd) has been recommended for approval in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setti...
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Fr., 31.01.2025       Daiichi Sankyo

Daiichi Sankyo Company, Ltd (TSE: 4568) has appointed Hiroyuki Okuzawa, 62, to succeed Sunao Manabe, DVM, Ph.D. as Chief Executive Officer (CEO), effective April 1, 2025. Dr. Manabe will transition from his current role of Representative Director, Executive Chairperson and CEO to Representative Director and Executive Chairperson while Mr. Okuzaw...
Fr., 31.01.2025       Daiichi Sankyo

The first patient has been dosed in the TROPION-Lung12 phase 3 trial evaluating the efficacy and safety of adjuvant DATROWAY® (datopotamab deruxtecan) plus rilvegostomig or rilvegostomig monotherapy versus standard of care in patients with stage 1 adenocarcinoma non-small cell lung cancer (NSCLC) after complete surgical resection who are ctDNA-pos...
Di., 28.01.2025       Daiichi Sankyo

Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined...
Fr., 17.01.2025       Daiichi Sankyo

DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. DATROWAY is a...
Mo., 13.01.2025       Daiichi Sankyo

Daiichi Sankyo Company, Ltd (TSE: 4568) announced today that it will pay Glycotope $132.5 million to acquire intellectual property rights of the anti-tumor-associated mucin-1 (TA-MUC1) antibody, gatipotuzumab. Such payment by Daiichi Sankyo satisfies all potential clinical, regulatory and sales milestone payments, as well as royalties of products...
Mo., 13.01.2025       Daiichi Sankyo

Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung ca...
Di., 24.12.2024       Daiichi Sankyo

Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have voluntarily withdrawn the marketing authorization application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) based on the TROPION-Lung01 phase 3 trial....
Di., 10.12.2024       Daiichi Sankyo

The first patient has been dosed in the QuANTUM-Wild phase 3 trial evaluating Daiichi Sankyo’s (TSE: 4568) VANFLYTA® (quizartinib) in combination with standard intensive induction and consolidation chemotherapy followed by single-agent maintenance in adults with newly diagnosed FLT3-ITD negative acute myeloid leukemia (AML). AML is an aggressive...
Mo., 09.12.2024       Daiichi Sankyo

Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC) with disease progression on or after treatment with an EGFR tyrosine kinase inhibito...
Fr., 06.12.2024       Daiichi Sankyo

A pooled analysis of the TROPION-Lung05 phase 2 and the TROPION-Lung01 phase 3 trials showed datopotamab deruxtecan (Dato-DXd) demonstrated clinically meaningful tumor response in patients with previously treated advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). These data, along with progression-free and overall survival res...
Mo., 02.12.2024       Daiichi Sankyo

Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 45 abstracts in multiple types of solid and blood cancers at the 2024 ESMO Asia Congress (#ESMOAsia24), San Antonio Breast Cancer Symposium (#SABCS24) and American Society of Hematology (#ASH24) Annual Meeting prior to its Science & Techn...
Mi., 13.11.2024       Daiichi Sankyo

Daiichi Sankyo (TSE: 4568) will highlight new clinical research and real-world data from seven abstracts for TURALIO® (pexidartinib) at the Connective Tissue Oncology Society (#CTOS2024) 2024 Annual Meeting. TURALIO is the first and only oral systemic therapy approved in the U.S. for adult patients with tenosynovial giant cell tumor (TGCT) assoc...
Di., 12.11.2024       Daiichi Sankyo

Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have submitted a new Biologics License Application (BLA) for accelerated approval in the U.S. for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung canc...
Mo., 11.11.2024       Daiichi Sankyo

DAEJEON, South Korea, Nov. 10, 2024 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170) announced today that the company has entered into an exclusive license agreement with Daiichi Sankyo (TSE: 4568). Under the terms of the agreement, Daiichi Sankyo will acquire world-wide rights to use ALT-B4, Alteogen's novel hyaluronidase utilizing Hybrozyme™ Techn...
Fr., 08.11.2024       Daiichi Sankyo

Daiichi Sankyo (TSE:4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have been awarded The Galien Foundation 2024 Prix Galien USA Award for Best Biotechnology Product for ENHERTU® (fam-trastuzumab deruxtecan-nxki). ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly develo...
Mi., 30.10.2024       Daiichi Sankyo

The first patients have been dosed in three global, randomized phase 3 trials evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd)-based combinations in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody dru...
Di., 01.10.2024       Daiichi Sankyo

Daiichi Sankyo (TSE: 4568) and AstraZeneca's (LSE/STO/Nasdaq: AZN) supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 wi...
Mo., 23.09.2024       Daiichi Sankyo

Topline results from the TROPION-Breast01 phase 3 trial of datopotamab deruxtecan (Dato-DXd) compared to investigator’s choice of chemotherapy, which previously met the dual primary endpoint of progression-free survival (PFS), did not achieve statistical significance in the final overall survival (OS) analysis in patients with inoperable or metast...
Di., 17.09.2024       Daiichi Sankyo

The HERTHENA-Lung02 phase 3 trial evaluating patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement versu...
So., 15.09.2024       Daiichi Sankyo

Initial results from dose escalation in the first-in-human phase 1 trial of DS-9606 suggest early promising clinical activity in patients with advanced solid tumors known to express Claudin-6 (CLDN6). These data were presented today during a Proffered Paper session (610O) at the 2024 European Society for Medical Oncology (#ESMO24). DS-9606 is an...
Fr., 13.09.2024       Daiichi Sankyo

Results from the DESTINY-Breast12 phase 3b/4 trial showed that ENHERTU® (trastuzumab deruxtecan) demonstrated substantial overall and intracranial clinical activity in a large cohort of patients with HER2 positive metastatic breast cancer who have brain metastases and received no more than two prior lines of therapy in the metastatic setting. Resu...
Mo., 09.09.2024       Daiichi Sankyo

Detailed results from the TROPION-Lung01 phase 3 trial showed a clinically meaningful trend toward improving overall survival (OS) with datopotamab deruxtecan (Dato-DXd) compared to docetaxel, the current standard of care chemotherapy, in adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) treated with...
So., 08.09.2024       Daiichi Sankyo

Results from an exploratory analysis of the TROPION-Lung01 phase 3 trial showed TROP2 as measured by quantitative continuous scoring (QCS), AstraZeneca’s proprietary computational pathology platform, was predictive of clinical outcomes in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who were treated with datopotamab deru...
Sa., 07.09.2024       Daiichi Sankyo

Results from an interim analysis of the dose-optimization part of the ongoing IDeate-Lung01 phase 2 trial showed ifinatamab deruxtecan (I-DXd) continues to demonstrate promising objective response rates in patients with pretreated extensive-stage small cell lung cancer (ES-SCLC). These data were featured today as part of a press conference and wil...
Mo., 19.08.2024       Daiichi Sankyo

Daiichi Sankyo (TSE: 4568) today announced that the European Medicines Agency (EMA) has validated the Type II Variation application for ENHERTU® (trastuzumab deruxtecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 low (defined as IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (defined as IHC 0 with membrane s...
Mo., 19.08.2024       Daiichi Sankyo

ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of unresectable or metastatic hormone receptor positive HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC >0 <1+) breast cancer patients who have received either two lines of endocrine therapy in the metastati...