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

Key Developments

• FDA approves Idvynso, a once-daily two-drug HIV regimen, marking a major milestone in Merck’s strategic pivot into chronic infectious disease management and positioning the company as a leader in next-generation HIV therapy.
• FDA expands approval of CAPVAXIVE to include children and adolescents (2–17) with chronic medical conditions, significantly broadening Merck’s vaccine footprint in high-risk pediatric populations and unlocking substantial new commercial opportunities.
• European Commission approves KEYTRUDA in combination with Padcev for neoadjuvant treatment of muscle-invasive bladder cancer, backed by Phase 3 data showing a 60% improvement in event-free survival and a 50% reduction in death risk—cementing KEYTRUDA’s dominance in immuno-oncology.
• FDA approves KEYTRUDA + Trodelvy combination for first-line treatment of PD-L1-positive triple-negative breast cancer, representing a transformative expansion into a high-unmet-need oncology indication with minimal competition and strong commercial upside.
• U.S. House Select Committee launches formal investigation into Merck’s clinical trial activities in Xinjiang and military-affiliated hospitals, raising severe geopolitical and reputational risks amid growing scrutiny of U.S.-China scientific collaboration.