MRK | Weekly | Haru Insights

The European Medicines Agency (EMA) issued a positive recommendation for the combination of Keytruda and Padcev in resectable muscle-invasive bladder cancer—marking a potential first-in-class PD-1 inhibitor plus ADC regimen in Europe, with approval expected by Q4 2026.
Merck voluntarily withdrew its BLA for ifinatamab deruxtecan (I-DXd) in ES-SCLC due to insufficient data for accelerated approval, underscoring critical regulatory risk and casting doubt on the future of MRK’s ADC platform pending the IDeate-Lung02 trial.

The EMA’s positive opinion on Keytruda + Padcev is a transformative milestone, establishing Merck as a pioneer in combination immunotherapy for bladder cancer and unlocking a high-growth, first-mover commercial opportunity in Europe.
WINREVAIR’s FDA label update—backed by a 76% reduction in clinical worsening in PAH—cements Merck’s dominance in pulmonary hypertension and positions the drug as a potential first-line standard of care, significantly expanding its market reach.
BRUNELLO trial success for remigromig, demonstrating non-inferiority to Lucentis with a first-in-class mechanism, validates Merck’s bold innovation in regenerative ophthalmology and opens a $5B+ market if safety hurdles are cleared.
Merck’s proactive development of treatments for a rare Ebola strain leverages its proven vaccine expertise, reinforcing its role in global health security and creating a strategic hedge against future patent cliffs.
The approval of subcutaneous Keytruda (KEYTRUDA QLEX) in Japan enhances patient convenience and clinic efficiency, demonstrating Merck’s ability to innovate in delivery formats and strengthen access in a high-value, mature market.

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