Merck Withdraws Ifinatamab Deruxtecan BLA After FDA Feedback

Daiichi Sankyo and Merck & Co Inc (NYSE: MRK) have withdrawn their Biologics License Application (BLA) for ifinatamab deruxtecan following FDA feedback. The FDA indicated that the current data from the IDeate-Lung01 Phase 2 trial did not meet criteria for accelerated approval in treating extensive-stage small cell lung cancer (ES-SCLC) after platinum chemotherapy.

The withdrawal of the BLA marks a significant development in Merck's oncology pipeline. The FDA's decision signals that the evidence presented was insufficient to grant accelerated approval for the drug's use in ES-SCLC patients who have undergone platinum-based chemotherapy.

Merck currently offers a dividend yield of 2.31%, which is moderate, but the payout ratio of 1.11 raises concerns about sustainability. The stock is currently overvalued by 23.2% compared to its GF Value of $120.81.