Merck and Daiichi Sankyo Withdraw FDA Application for Lung Cancer Drug

Key Facts

1Merck and Daiichi Sankyo voluntarily withdrew their Biologics License Application from the FDA for a lung cancer drug.

2The withdrawal was due to insufficient data to support the application, though ongoing clinical trials will continue.

Merck and Daiichi Sankyo voluntarily withdrew their Biologics License Application from the FDA for a lung cancer drug. Benzinga reported that the decision was driven by insufficient data to support the application at this stage, effectively halting the current regulatory approval path.

The companies stated that ongoing clinical trials will continue to gather further data despite the withdrawal. Regarding market performance, MRK closed at $148.74 on September 25, 2026, while DSNKY closed at $18.67 on the same date.