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

Key Developments

• Merck voluntarily withdrew its BLA for ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer due to safety concerns, including a 12.4% rate of treatment-related interstitial lung disease and two fatal cases – This retreat marks a major strategic setback, exposing deep vulnerabilities in Merck’s antibody-drug conjugate (ADC) platform and raising urgent questions about its ability to deliver next-generation oncology therapies beyond Keytruda.

• The European Medicines Agency (EMA) issued a positive recommendation for KEYTRUDA plus Padcev in resectable muscle-invasive bladder cancer, potentially paving the way for European Commission approval by Q4 2026 – This landmark regulatory validation solidifies Merck’s first-mover advantage in a high-need, high-volume indication with ~56,000 eligible patients.

• Tulisokibart achieved 72% HiSCR50 response rates in Phase 2b for moderate to severe hidradenitis suppurativa, representing a breakthrough in dermatology and a potential cornerstone for a new immunology franchise beyond oncology – This is a rare late-stage success and validates Merck’s bet on anti-TL1A targeting in immuno-fibrosis.