Will FDA Filing Withdrawal Change Daiichi Sankyo Stock Narrative

Daiichi Sankyo and Merck withdrew their FDA application for accelerated approval of ifinatamab deruxtecan in extensive-stage small cell lung cancer due to Phase 2 trial data not meeting requirements. The decision emphasizes the reliance on late-stage trial success for Daiichi Sankyo's antibody drug conjugate strategy and shifts investor focus to ongoing Phase 3 trials that will determine future oncology growth and R&D outcomes.

This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 26 Sep 2026 and 28 Sep 2026.