Merck & Co., Inc. (MRK)[Tv]

Key Developments

• EMA issues positive recommendation for KEYTRUDA + Padcev in perioperative treatment of muscle-invasive bladder cancer (MIBC) – Based on the robust Phase III KEYNOTE-905 data, this marks a transformative regulatory validation that could expand KEYTRUDA’s footprint in first-line and earlier-stage oncology, unlocking major revenue potential across EU markets.

• FDA grants Breakthrough Therapy designation to calderasib (MK-1084) + KEYTRUDA for first-line metastatic NSCLC with KRAS G12C mutations – This pivotal advance confirms Merck’s leadership in precision oncology, targeting a historically "undruggable" mutation and positioning a potential blockbuster in one of the largest lung cancer subtypes.

• Positive Phase 3 TroFuse-005 results for sacituzumab tirumotecan (sac-TMT) in advanced endometrial cancer – The first TROP2-directed ADC to show significant survival benefit over chemotherapy in a global Phase III trial, establishing a major therapeutic breakthrough and validating Merck’s TroFuse platform as a sustainable growth engine.

• FDA approves expanded use of PD-L1 IHC 22C3 pharmDx diagnostic on Dako Omnis platform – This deepens Merck’s integration into the KEYTRUDA diagnostic ecosystem, streamlining patient testing and strengthening long-term commercial moat by locking in clinical adoption and market share.