Merck (MRK) announced the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of KEYTRUDA, Merck's anti-PD-1 therapy, in combination with Padcev, an antibody-drug conjugate, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy. The recommendation is based on results from the Phase 3 KEYNOTE-905 trial, which was conducted in collaboration with Pfizer and Astellas.
The recommendation, which also includes KEYTRUDA SC, will now be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein and Norway, and a final decision is expected by the third quarter of 2026.
In pre-market trading on NYSE, Merck shares are up 2.57 percent to $118.85.
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Business News
May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.