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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Business News
April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.