DAIICHI SANKYO COMPANY LIMITED TSE:4568 Price, Chart, News & Insight

Daiichi Sankyo Company, Limited (TSE: 4568) announced that it has rescheduled the announcement of consolidated financial results for
year ended March 31, 2026, originally scheduled for April 27, 2026

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WS Investor 04-24-26

Tokyo, April 15, 2026 — Daiichi Sankyo Company announced an agreement to sell its consolidated subsidiary, Daiichi Sankyo Healthcare Co., Ltd. (DSHC), to Suntory Holdings in a deal valued at approximately JPY 246.5 billion.

Under the terms of the agreement, the transaction will be executed in stages. Daiichi Sankyo will initially transfer a 30% stake in DSHC in June 2026, with the full divestment expected to be completed by June 2029.

The move marks a strategic shift for Daiichi Sankyo as it streamlines its business portfolio, while Suntory strengthens its position in the healthcare sector through the acquisition.

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Global Finance News 04-15-26

Daiichi Sankyo and Merck & Co. announced that the U.S. Food and Drug Administration has granted Priority Review to the Biologics License Application for ifinatamab deruxtecan (I-DXd), a potential new treatment for extensive-stage small cell lung cancer (ES-SCLC).

The therapy is intended for adult patients whose disease has progressed after platinum-based chemotherapy, an area with limited treatment options. If approved, it would become a first-in-class B7-H3 directed antibody-drug conjugate.

The application is supported by results from the Phase 2 IDeate-Lung01 trial, with additional data from the Phase 1/2 IDeate-PanTumor01 study. The drug had previously received Breakthrough Therapy Designation from the FDA in August 2025.

The FDA is reviewing the application under Priority Review, as well as its Real-Time Oncology Review and Project Orbis programs, which aim to accelerate access to promising cancer treatments. A regulatory decision is expected by October 10, 2026.

Overall, the development marks a significant step toward a new treatment option for a highly aggressive cancer type, with potential to address unmet medical needs in late-stage small cell lung cancer.

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WS Investor 04-14-26

ENHERTU, developed by Daiichi Sankyo and AstraZeneca, has been approved in China for the neoadjuvant treatment of HER2-positive early-stage breast cancer.

The approval, granted by China’s National Medical Products Administration, marks the first global use of ENHERTU in a curative-intent early breast cancer setting and the first HER2-directed antibody-drug conjugate approved in China for this purpose.

The decision is based on Phase 3 DESTINY-Breast11 trial results, where ENHERTU followed by THP achieved a significantly higher pathologic complete response rate of 67.3%, compared to 56.3% with standard therapy.

The treatment demonstrated a manageable safety profile consistent with prior data, with no new safety concerns identified. The approval is conditional, pending confirmation of long-term clinical benefits in ongoing studies.

This marks the seventh approval for ENHERTU in China in three years, highlighting rapid adoption of the therapy in a market with high breast cancer incidence and significant unmet medical need.

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Global Finance News 03-27-26

Daiichi Sankyo announced that ENHERTU (trastuzumab deruxtecan) has been approved in Japan as the first tumor-agnostic HER2-directed therapy for patients with previously treated HER2-positive metastatic solid tumors.

The approval by Japan’s Ministry of Health is based on results from four phase 2 trials, where the drug demonstrated clinically meaningful response rates across multiple tumor types, including lung, colorectal, and gynecological cancers.

This milestone expands ENHERTU’s use to six indications in Japan and highlights the growing role of HER2 testing across a wide range of cancers, although the treatment carries known safety risks such as interstitial lung disease requiring close monitoring.

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European Investor 03-23-26

Daiichi Sankyo announced that its patent dispute with Seagen has officially concluded after the U.S. Court of Appeals for the Federal Circuit reversed a lower court ruling that had upheld Seagen’s U.S. Patent No. 10,808,039. The appeals court vacated the prior infringement judgment and damages award against Daiichi Sankyo, while also dismissing Seagen’s appeal regarding a U.S. Patent and Trademark Office decision that invalidated the patent claims. With the deadlines to seek further review passing on March 2, 2026, the legal dispute between the two companies has now formally ended.

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The Investor 03-10-26

ENHERTU has advanced in its regulatory pathway in Europe, with the European Medicines Agency validating a Type II Variation application for its use as post-neoadjuvant treatment in patients with HER2-positive early breast cancer.

The application seeks approval for ENHERTU as a monotherapy in adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant HER2-targeted therapy. Validation by the EMA confirms that the submission is complete and initiates the scientific review process by the Committee for Medicinal Products for Human Use (CHMP).

The filing is supported by results from the Phase 3 DESTINY-Breast05 trial, where ENHERTU demonstrated a 53% reduction in the risk of invasive disease recurrence or death compared with trastuzumab emtansine (T-DM1). The data were presented at the 2025 European Society for Medical Oncology Congress and published in The New England Journal of Medicine.

Developed by Daiichi Sankyo and co-developed and commercialized with AstraZeneca, ENHERTU is a HER2-directed DXd antibody-drug conjugate. If approved, it could become a new standard of care for patients with residual invasive HER2-positive early breast cancer following neoadjuvant therapy.

Additional EU regulatory submissions for ENHERTU are also underway, including combination use with pertuzumab in first-line metastatic HER2-positive breast cancer and expanded indications across other HER2-positive solid tumors.

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The Investor 02-19-26

## Daiichi Sankyo Submits sNDA in Japan for DATROWAY in First-Line Metastatic TNBC

Tokyo, February 12, 2026 — Daiichi Sankyo announced it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare for DATROWAY (datopotamab deruxtecan) to treat adult patients with hormone receptor-negative, HER2-negative unresectable or recurrent breast cancer, commonly known as triple negative breast cancer (TNBC).

The filing is based on results from the phase 3 TROPION-Breast02 trial, where DATROWAY demonstrated statistically significant and clinically meaningful improvements in overall survival and progression-free survival compared to chemotherapy as a first-line treatment for metastatic TNBC patients who are not candidates for immunotherapy.

If approved, DATROWAY could become the first TROP2-directed antibody drug conjugate (ADC) available in Japan for first-line metastatic TNBC. Approximately 70% of patients in this setting are not eligible for immunotherapy, leaving chemotherapy as the only current first-line option.

DATROWAY is a TROP2-directed ADC developed using Daiichi Sankyo’s proprietary DXd technology platform. The company is also pursuing additional global regulatory submissions for DATROWAY in breast and lung cancers.

Source: Daiichi Sankyo press release, February 12, 2026.

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Global Finance News 02-12-26

Daiichi Sankyo announced that the first patient has been dosed in a first-in-human phase 1/2 clinical trial of DS3790, marking the company’s first DXd antibody drug conjugate (ADC) to enter clinical development in hematology. The investigational therapy is being evaluated in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

DS3790 is a potential first-in-class CD37-directed DXd ADC, targeting a protein that is highly expressed on malignant B-cells and for which no approved cancer therapies currently exist. The global study will assess safety, dosing, and preliminary efficacy of DS3790 as a monotherapy, with later cohorts planned to evaluate combinations with other targeted therapies.

Source: Daiichi Sankyo press release

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Global Finance News 02-07-26

Daiichi Sankyo Company announced that its board has approved the basic policy to merge its wholly owned subsidiary, Daiichi Sankyo Business Associe, into the parent company through an absorption-type merger. The simplified merger is scheduled to take effect on October 1, 2027, and will not require shareholder approval.

The subsidiary, established in 2006, currently provides shared services such as personnel and accounting for group companies in Japan. Daiichi Sankyo said the integration aims to eliminate the intercompany entrustment model, streamline operations, and improve efficiency by enabling more flexible consolidation and global standardization of business processes. As the transaction involves a wholly owned subsidiary, no new shares will be issued and no cash consideration will be paid, and the impact on consolidated financial results is expected to be immaterial.

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WS Investor 01-30-26

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