Withdrawn Merck and Daiichi Sankyo withdrew the BLA for ifinatamab deruxtecan on September 25, 2026, fifteen days before its October 10, 2026 goal date. In the companies' words, the decision was based on discussions with the FDA that "data supporting the application, including from the IDeate-Lung01 Phase 2 trial, do not satisfy requirements needed to support an accelerated approval for the proposed indication" (Merck and Daiichi Sankyo release, September 25, 2026). No FDA decision was issued, so this is neither an approval nor a Complete Response Letter, and it is not counted in pdufa.bio's FDA decision timing statistic.
The application was listed on the pdufa.bio calendar with an October 10, 2026 goal date, sourced to Merck & Co., Inc. 10-Q 2026-05-04. It has been removed from every upcoming list. Other MRK FDA dates and decisions: MRK FDA calendar; all dates: PDUFA calendar.
No. Merck and Daiichi Sankyo withdrew the BLA for ifinatamab deruxtecan on September 25, 2026, before the FDA acted on it, so no FDA decision was issued. The October 10, 2026 PDUFA goal date no longer applies.
Merck and Daiichi Sankyo said the withdrawal was based on discussions with the FDA that data supporting the application, including from the IDeate-Lung01 Phase 2 trial, do not satisfy requirements needed to support an accelerated approval for the proposed indication.
No. The goal date was set for the BLA that was withdrawn on September 25, 2026. A new goal date would follow only a new submission and its acceptance by the FDA.
The companies said patient enrollment continues in the IDeate-Lung02 Phase 3 trial, and that they will assess a potential future filing based on its results.
Facts from the sponsor's release and SEC filing, each linked. Not a prediction, and not investment advice.