Merck Pulls U.S. Filing for Lung Cancer Drug After FDA Rejects Data
MRK sits 92% above its 52-week low of $77.58.
Summary
Merck and Daiichi Sankyo withdrew their U.S. BLA for ifinatamab deruxtecan in extensive-stage small cell lung cancer after the FDA said Phase 2 IDeate-Lung01 data were insufficient for accelerated approval. The withdrawal removes a near-term approval path and pushes the program to a Phase 3-dependent timeline; enrollment continues in IDeate-Lung02. This is a material negative for the oncology pipeline, though Keytruda and Winrevair remain the dominant revenue drivers. Watch for Phase 3 IDeate-Lung02 results as the next binary catalyst for this asset.
At the time of this announcement, MRK was trading at $148.75 on NYSE in the Life Sciences sector, with a market capitalization of approximately $367.1B. The 52-week trading range was $77.58 to $156.92. This news item was assessed with negative market sentiment and an importance score of 8 out of 10. Source: Wiseek News.