Story
Daiichi Sankyo Stock Drops After US Application for Cancer Drug Withdrawn
Summary
Shares in the Japanese pharmaceutical company fell after it and partner Merck pulled an application for accelerated FDA approval of an experimental lung cancer therapy, citing insufficient data from a mid-stage trial.
Shares of Daiichi Sankyo (TYO:4568) declined on Monday after the company and its partner Merck announced the withdrawal of a U.S. regulatory application for an experimental lung cancer treatment. The stock fell 3.0% to close at ¥2,840 following the news.
Regulatory Setback
In a statement on Friday, the two pharmaceutical firms said they had withdrawn a Biologics License Application (BLA) submitted to the U.S. Food and Drug Administration (FDA). The application sought accelerated approval for ifinatamab deruxtecan, a potential therapy for certain types of lung cancer.
According to the companies, the FDA determined that data from a mid-stage clinical study was insufficient to support the requirements for an early approval pathway. The accelerated approval process allows for earlier patient access to drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint.
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This marks the second setback for a cancer therapy co-developed under the 2023 partnership between Daiichi Sankyo and Merck. In the previous year, the partners dropped an application for a different lung cancer candidate after a late-stage study revealed it had little meaningful efficacy.
Regulatory delays and rejections can significantly impact a drug's path to market, affecting future revenue projections and investor sentiment. Despite the withdrawal, Daiichi Sankyo and Merck indicated they will continue their evaluation of ifinatamab deruxtecan.
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