Daiichi Sankyo: Delayed Progress After I-DXd BLA Withdrawal in Extensive-Stage SCLC
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On September 25, 2026, Daiichi Sankyo announced the voluntary withdrawal of its Biologics License Application for I-DXd, a B7-H3 antibody-drug conjugate, in second-line extensive-stage small cell lung cancer. The company plans to resubmit via the Phase III IDeate-Lung02 study, whose primary completion date is expected on January 30, 2028. CLSA reads the FDA's caution on the Phase II IDeate-Lung01 dataset as reflecting intensifying competition in second-line SCLC and a higher evidence bar, with rival drugs already approved or in development. Near term, the AVANZAR study readout for Datroway is flagged as a key catalyst before end-2026, alongside four Phase III NSCLC trial readouts expected across 2026 and 2027. The sequence—regulatory caution prompting the withdrawal, a pivot to confirmatory Phase III evidence and an anticipated 2028 refiling—frames the investment timeline as investors await these catalysts. The note provides company background and consensus target price information rather than an explicit buy or sell rating.