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

Key Developments

• European Commission approves KEYTRUDA in combination with Pfizer’s Padcev for neoadjuvant treatment of muscle-invasive bladder cancer (MIBC) – This landmark approval, backed by strong Phase 3 data from KEYNOTE-905, cements Merck’s dominance in immuno-oncology and opens a high-margin, premium-priced revenue stream in a disease area with significant unmet need.

• FDA expands approval of CAPVAXIVE to children and adolescents (2–17) with chronic medical conditions – This regulatory win strengthens Merck’s vaccine franchise and unlocks a high-risk, underserved pediatric market with substantial commercial and public health potential.

• FDA approves Idvynso, a once-daily two-drug HIV regimen, marking a major milestone in Merck’s pivot into chronic infectious disease management – The approval underscores Merck’s growing strength in HIV, complements its pipeline of next-gen regimens, and positions the company as a key player beyond oncology.