Daiichi Sankyo stock faces setback after I-DXd filing withdrawal

Published on 10/07/2026 at 01:36 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Daiichi Sankyo stock was last at JPY 2,752 on October 6, 2026, after an I-DXd filing withdrawal. First-quarter revenue rose 21.1 percent.

Daiichi Sankyo, JP3475350009, Illustration mit AI erstellt.

Daiichi Sankyo stock (ISIN JP3475350009) was last at JPY 2,752 on the Tokyo Stock Exchange on October 6, 2026 at 3:30 p.m. JST, up 1.33 percent. The move came as the company and Merck withdrew the U.S. filing for ifinatamab deruxtecan, or I-DXd, after FDA feedback on the supporting Phase 2 data, Pharmaphorum reported on October 6, 2026.

FDA setback shifts the timeline

The withdrawn application sought accelerated approval for I-DXd in previously treated extensive-stage small-cell lung cancer. The FDA indicated that results from the IDeate-Lung01 Phase 2 trial did not satisfy the requirements for the proposed indication, according to BioPharma Dive on October 6, 2026.

The trial produced an objective response rate of 54.8 percent, but the application was withdrawn before the October 10 action date. Enrollment in the Phase 3 IDeate-Lung02 trial continues, giving the drug program a later route toward a conventional filing.

Revenue grows faster than profit

Daiichi Sankyo's first-quarter fiscal 2026 revenue rose 21.1 percent year over year to JPY 574.7 billion, while core operating profit increased 6.2 percent to JPY 107.3 billion, according to Stock Sentinel in its September 23, 2026 research report. Reported operating profit declined 12.0 percent to JPY 85.1 billion, showing that sales growth has not translated into equal reported profit growth.

The company also raised fiscal 2026 revenue guidance to JPY 2.34 trillion and operating profit guidance to JPY 320.0 billion in its July 31, 2026 results presentation, according to the same report. For investors, the key tension is the gap between accelerating oncology sales and the costs linked to restructuring, manufacturing and profit sharing.

Analysts keep a higher valuation

MarketScreener listed a BUY consensus from 16 analysts on September 18, 2026, with an average target of JPY 4,096.25. The consensus figure is a forward assessment rather than a company forecast, and its relevance now depends on whether the Phase 3 IDeate-Lung02 data can offset the I-DXd regulatory setback.

Daiichi Sankyo's investor page lists the FY2026 second-quarter financial results briefing for October 30, 2026, providing the next scheduled checkpoint for revenue, profit and pipeline updates, Daiichi Sankyo states.

Stock remains below yearly high

Daiichi Sankyo stock was last at JPY 2,752 on October 6, 2026, with a 52-week range of JPY 2,390 to JPY 4,178. Market capitalization stood at JPY 5.0 trillion and trading volume reached 3,925,600 shares on the same session.