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News 2026-09-28 22:01 UTC

Weekly Recap: U.S. BLA withdrawn for I—DxD and Phase 3s continue

Daiichi Sankyo Company, Limited (TSE:4568) withdrew its U.S. BLA for ifinatamab deruxtecan after FDA said current Phase 2/supporting data don’t justify accelerated approval, yet the company and partners press on with Phase 3 trials (IDeate—Lung02 and others) while facing an NTK appeal in Tokyo over…