Merck (MRK) announced the FDA granted priority review for two supplemental Biologics License Applications for KEYTRUDA and KEYTRUDA QLEX, Merck's anti-PD-1 therapy, each in combination with Padcev, for the treatment of patients with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy. The FDA set a PDUFA, or target action, date of August 17, 2026.
The sBLAs are based on data from the Phase 3 KEYNOTE-B15 trial, which was conducted in collaboration with Pfizer and Astellas. The companies plan to share the results with regulatory authorities worldwide for potential regulatory filings.
In pre-market trading on NYSE, Merck shares are down 0.46 percent to $118.52.
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May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.