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Daiichi Sankyo Co Ltd (D4S.BE)

26.62

+0.28

+(1.06%)

As of 8:09:58 AM GMT+1. Market Open.

FDA Approves AstraZeneca's Datroway For Pretreated Breast Cancer Patients

On Friday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca Plc’s (NASDAQ:AZN) Datroway (datopotamab deruxtecan or Dato-DXd) for 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. The approval was based on results from the TROPION-Breast01 Phase 3 trial. Read Next: AstraZeneca Aims to Restor

Benzinga 5 days ago

AZN

4568.T
+1.34%
DATROWAY® Approved in the U.S. for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

TOKYO & BASKING RIDGE, N.J., January 17, 2025--DATROWAY Approved in the U.S. for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

Business Wire 9 days ago

DSKYF
+5.07%
DSNKY
Daiichi Sankyo buys solid tumour ADC from Glycotope for $132.5m

The acquisition builds on a 2017 option agreement and subsequent 2018 licensing deal with Glycotope.

Pharmaceutical Technology 12 days ago

4568.T
+1.34%
GLDAF
Daiichi Sankyo Acquires Intellectual Property Rights for Anti-TA-MUC1 Antibody in DS-3939 from Glycotope GmbH

TOKYO & BASKING RIDGE, N.J., January 13, 2025--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 that include gatipotuzumab as part of a 2018 licensing agreement between the parties. In 2018, Daiichi S

Business Wire 13 days ago

DSKYF
+5.07%
DSNKY
Datopotamab Deruxtecan Granted Priority Review in the U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer

TOKYO & BASKING RIDGE, N.J., January 13, 2025--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 cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy.

Business Wire 14 days ago

DSKYF
+5.07%
DSNKY
AZN, Daiichi Withdraw EU Filing for Dato-DXd in Nonsquamous NSCLC

AstraZeneca and Daiichi Sankyo voluntarily withdraw regulatory filing for Dato-DXd in nonsquamous non-small cell lung cancer in the European Union.

Zacks last month

AZN

4568.T
+1.34%
PFE
AstraZeneca, Daiichi Sankyo withdraw EU application for lung cancer treatment

The application for Dato-DXd was supported by results from the Phase III TROPION-Lung01 clinical trial.

Pharmaceutical Technology last month

4568.T
+1.34%
AZN
Datopotamab Deruxtecan Application in the EU for Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer Voluntarily Withdrawn

TOKYO & MUNICH, December 24, 2024--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.

Business Wire last month

DSKYF
+5.07%
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Daiichi Sankyo doses first subject in Phase III AML therapy trial

Subjects in the trial will be randomised into three treatment arms.

Clinical Trials Arena last month

4568.T
+1.34%
AZN, Daiichi's ADC Gets FDA Breakthrough Tag for EGFR-Mutated NSCLC

The FDA bestows a Breakthrough Therapy designation to AstraZeneca and Daiichi Sankyo's Dato-DXd for previously treated advanced EGFR-mutated NSCLC.

Zacks last month

AZN

4568.T
+1.34%
PFE
QuANTUM-Wild Phase 3 Trial of VANFLYTA® Initiated in Patients with Newly Diagnosed FLT3-ITD Negative AML

TOKYO & BASKING RIDGE, N.J., December 10, 2024--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).

Business Wire last month

DSKYF
+5.07%
DSNKY
Daiichi Sankyo secures breakthrough designation for NSCLC treatment

Developed alongside AstraZeneca, the breakthrough designation comes following early pooled results from two ongoing trials finding the drug was well tolerated.

Pharmaceutical Technology last month

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Datopotamab Deruxtecan Granted Breakthrough Therapy Designation in U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer

TOKYO & BASKING RIDGE, N.J., December 09, 2024--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 inhibitor (TKI) and platinum-based chemotherapy.

Business Wire last month

DSKYF
+5.07%
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Datopotamab Deruxtecan Demonstrated Meaningful Clinical Activity in Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer in TROPION-Lung05 and TROPION-Lung01 Pooled Analysis

TOKYO & BASKING RIDGE, N.J., December 06, 2024--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 results from the analysis, were presented during a late-breaking proffered paper session (LBA7) at the 202

Business Wire last month

DSKYF
+5.07%
DSNKY
Daiichi Sankyo Highlights Progress Across Oncology Portfolio in Multiple Solid and Blood Cancers at ESMO Asia, SABCS and ASH

BASKING RIDGE, N.J., December 02, 2024--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 & Technology Day.

Business Wire last month

DSKYF
+5.07%
DSNKY
Daiichi Sankyo exec on purposeful data collection

The company’s VP of digital excellence explains how the Japanese biotech engages with data and uses it to inform decision making.

Clinical Trials Arena 2 months ago

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+1.34%
Daiichi Sankyo and AstraZeneca’s Enhertu snubbed by UK’s NICE for third time

Charity Breast Cancer Now has described the failure to negotiate a fair price of Enhertu as “utterly heartbreaking”.

Pharmaceutical Technology 2 months ago

4568.T
+1.34%
AZN

GLDAF
GRAIL Announces First Patient Tested With Blood-Based Assay in Global Phase 3 Adjuvant Lung Cancer Study

GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced that the first patient has been tested for eligibility with the investigational GRAIL Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay in the global TROPION-Lung12 Phase 3 study evaluating adjuvant treatment regimens in patients with Stage I adenocarcinoma NSCLC. The study is sponsored by AstraZeneca (LSE/STO/Nasdaq:AZN) in collaboration with Daiichi Sankyo (TSE: 4568).

PR Newswire 2 months ago

DSKYF
+5.07%
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GRAL
Daiichi Sankyo to Showcase TURALIO® Research in Patients with Tenosynovial Giant Cell Tumor at CTOS

BASKING RIDGE, N.J., November 13, 2024--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.

Business Wire 2 months ago

DSKYF
+5.07%
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AstraZeneca, Daiichi revise approval plans for Enhertu successor

Following mixed study results, the partners have backed away from seeking broad clearance of dato-dxd in lung cancer and instead are aiming for a narrower approval.

BioPharma Dive 2 months ago

AZN

4568.T
+1.34%

Performance Overview

Return	D4S.BE	Nikkei 225
YTD	+2.27%	-0.82%
1-Year	+179,855,910.00%	+10.67%
3-Year	+12,094,156,800.00%	+51.19%

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Daiichi Sankyo Co Ltd (D4S.BE)

FDA Approves AstraZeneca's Datroway For Pretreated Breast Cancer Patients

DATROWAY® Approved in the U.S. for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

Daiichi Sankyo buys solid tumour ADC from Glycotope for $132.5m

Daiichi Sankyo Acquires Intellectual Property Rights for Anti-TA-MUC1 Antibody in DS-3939 from Glycotope GmbH

Datopotamab Deruxtecan Granted Priority Review in the U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer

AZN, Daiichi Withdraw EU Filing for Dato-DXd in Nonsquamous NSCLC

AstraZeneca, Daiichi Sankyo withdraw EU application for lung cancer treatment

Datopotamab Deruxtecan Application in the EU for Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer Voluntarily Withdrawn

Daiichi Sankyo doses first subject in Phase III AML therapy trial

AZN, Daiichi's ADC Gets FDA Breakthrough Tag for EGFR-Mutated NSCLC

QuANTUM-Wild Phase 3 Trial of VANFLYTA® Initiated in Patients with Newly Diagnosed FLT3-ITD Negative AML

Daiichi Sankyo secures breakthrough designation for NSCLC treatment

Datopotamab Deruxtecan Granted Breakthrough Therapy Designation in U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Datopotamab Deruxtecan Demonstrated Meaningful Clinical Activity in Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer in TROPION-Lung05 and TROPION-Lung01 Pooled Analysis

Daiichi Sankyo Highlights Progress Across Oncology Portfolio in Multiple Solid and Blood Cancers at ESMO Asia, SABCS and ASH

Daiichi Sankyo exec on purposeful data collection

Daiichi Sankyo and AstraZeneca’s Enhertu snubbed by UK’s NICE for third time

GRAIL Announces First Patient Tested With Blood-Based Assay in Global Phase 3 Adjuvant Lung Cancer Study

Daiichi Sankyo to Showcase TURALIO® Research in Patients with Tenosynovial Giant Cell Tumor at CTOS

AstraZeneca, Daiichi revise approval plans for Enhertu successor

Performance Overview