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

Key Developments

• EMA issues positive CHMP opinion for KEYTRUDA + Padcev in resectable muscle-invasive bladder cancer, marking a potential first-in-class PD-1 inhibitor plus ADC regimen in Europe and setting the stage for European Commission approval by Q4 2026—a landmark regulatory validation of Merck’s combination strategy and a major step toward first-mover commercial advantage in a high-need, high-volume indication.

• Tulisokibart achieves pivotal Phase III success in ulcerative colitis (ATLAS-UC trial), meeting primary endpoint for clinical remission at week 12—a breakthrough that cements Merck’s legitimacy as a true innovator in IBD with a novel mechanism poised to disrupt the anti-TNF space and capture first-line therapy share.

• FDA approves LIPFENDRA, the first oral PCSK9 inhibitor, delivering a transformative diversification into cardiometabolic health with massive long-term commercial potential and positioning Merck for sustainable growth beyond oncology, even as Keytruda-dependent growth faces headwinds.