Streetbeat News

DSNKY

Daiichi Sankyo Co., Ltd.

https://www.daiichisankyo.co.jp/

CEO

Sunao Manabe

Industry

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

第一三共（株） is a chemicals company based out of 日本橋本町３丁目５－１第一三共本社ビルａ館ｂ館, 中央区, 東京都, japan.

Open

29.66

Mkt cap

56B

Volume

21K

High

29.68

P/E Ratio

34.81

52-wk high

42.48

Low

29.58

Div yield

N/A

52-wk low

26.05

The FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of patritumab deruxtecan, a lung cancer drug developed by Daiichi Sankyo and Merck, due to issues at a third-party manufacturing facility. The CRL did not raise concerns about the drug's efficacy or safety. Merck's stock was down 1.04% following the news.

Portfolio Pulse from Vandana Singh

June 27, 2024 | 2:13 pm

Daiichi Sankyo and AstraZeneca's ENHERTU has shown significant progression-free survival benefits in HR positive, HER2 low metastatic breast cancer, according to the DESTINY-Breast06 trial. Additional data from DESTINY-Breast03 and DESTINY-Breast07 trials reinforce ENHERTU as a standard of care in the second-line setting and highlight its potential in the first-line setting.

Portfolio Pulse from Benzinga Newsdesk

June 03, 2024 | 6:49 am

AstraZeneca's stock is trading lower due to the TROPION-Lung01 phase 3 trial results, which did not reach statistical significance in overall survival for the entire trial population. However, the drug showed clinically meaningful improvement in a specific subgroup of patients.

Portfolio Pulse from Vandana Singh

May 28, 2024 | 6:32 pm

Daiichi Sankyo and AstraZeneca's Datopotamab Deruxtecan shows improved survival rates versus chemotherapy in advanced nonsquamous non-small cell lung cancer patients in the TROPION-Lung01 Phase 3 trial. While the survival results favored the drug, they did not reach statistical significance. The trial had previously met the dual primary endpoint of progression-free survival. These results support ongoing regulatory reviews globally, including in the U.S. and EU.

Portfolio Pulse from Benzinga Newsdesk

May 28, 2024 | 7:03 am

AstraZeneca reported positive results from a metastatic breast cancer treatment study for Enhertu, showing significant improvement in progression-free survival. Additionally, AstraZeneca's Truqap, in combination with Faslodex, is recommended for approval in the EU for certain breast cancer patients. Daiichi Sankyo, co-developer of Enhertu, also plays a role in these developments.

Portfolio Pulse from Vandana Singh

April 29, 2024 | 1:26 pm

The FDA granted accelerated approval to Enhertu, a drug developed by AstraZeneca and Daiichi Sankyo, for treating patients with unresectable or metastatic HER2 positive solid tumors who have undergone prior systemic treatment. This approval, based on objective response rate and duration of response from phase 2 trials, marks a significant milestone as the first tumor agnostic HER2-directed therapy. AstraZeneca's stock saw a slight increase following the announcement.

Portfolio Pulse from Vandana Singh

April 08, 2024 | 2:34 pm

The U.S. FDA has accepted the Biologics License Application (BLA) for Datopotamab Deruxtecan, a joint development by Daiichi Sankyo and AstraZeneca, aimed at treating metastatic breast cancer. This marks a significant step forward in the fight against this severe form of cancer.

Portfolio Pulse from Benzinga Newsdesk

April 02, 2024 | 6:18 am

The FDA has accepted the Biologics License Application (BLA) for datopotamab deruxtecan, a potential first TROP2 directed antibody drug conjugate for non-squamous NSCLC after prior therapy, developed by Daiichi Sankyo and AstraZeneca. The application is based on results from the TROPION-Lung01 phase 3 trial.

Portfolio Pulse from Charles Gross

February 19, 2024 | 3:56 pm

The FDA has accepted and granted priority review for Daiichi Sankyo and AstraZeneca's supplemental Biologics License Application for ENHERTU to treat metastatic HER2 positive solid tumors. The application is supported by results from the DESTINY-PanTumor02 trial and additional ENHERTU data. The review will be conducted under the FDA's Real Time Oncology Review and Project Orbis, and if approved, ENHERTU could become the first HER2 directed treatment and antibody drug conjugate with a tumor agnostic indication.

Portfolio Pulse from Benzinga Newsdesk

January 29, 2024 | 7:19 am

Pfizer Inc (NYSE:PFE) is expected to report a Q4 2023 EPS loss of $(0.22) and revenues of $14.25 billion. The company's FY24 revenue forecast includes contributions from the Seagen acquisition, with adjusted EPS guidance lower than consensus. Pfizer's obesity drug trial showed efficacy but had high dropout rates due to side effects. Additionally, a former Pfizer employee was convicted of securities fraud. PFE shares dropped 1.69% in premarket trading.

Portfolio Pulse from Vandana Singh

January 25, 2024 | 2:26 pm

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