CompanyShort-termNeutralDays to weeksBenzingaMRK

Merck, Daiichi Sankyo Voluntarily Withdraw Biologics License Application Approval In U.S. For Ifinatamab Deruxtecan To Treat Small Cell Lung Cancer After Discussions With FDA

Reviewed by ClearTape · Source: Benzinga

Key takeaways

Merck and Daiichi Sankyo pulled their accelerated‑approval filing for I‑DXd in ES‑SCLC after FDA feedback that the data were insufficient.
No specific numeric figures reported

What happened

Merck (NYSE: MRK) and Daiichi Sankyo voluntarily withdrew their Biologics License Application for ifinatamab deruxtecan (I‑DXd) to treat extensive‑stage small cell lung cancer (ES‑SCLC) after discussions with the U.S. Food and Drug Administration.

Why it matters

The withdrawal means the drug will not receive accelerated approval in the U.S. for this indication, delaying potential access for patients and impacting the companies’ pipeline prospects.

Short-term and longer-term

Short-term. Short‑term traders should note that the withdrawal removes a potential catalyst for Merck’s oncology pipeline.

Longer-term. Longer‑term investors should consider the impact on Merck’s oncology portfolio and the partnership with Daiichi Sankyo.

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