Merck & Co., Inc. (MRK) Gains FDA Priority Review for KEYTRUDA Regimen in Muscle-Invasive Bladder Cancer

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On April 20, MRK announced that the U.S. Food and Drug Administration granted Priority Review to two supplemental Biologics License Applications for KEYTRUDA and KEYTRUDA QLEX, each used in combination with Padcev for patients with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy.

The FDA assigned a target action date of August 17, 2026. The applications are supported by Phase 3 KEYNOTE-B15 data evaluating perioperative treatment with surgery compared to standard chemotherapy. Results from the program showed improved outcomes, including survival benefits, across multiple bladder cancer studies. The combination is already approved in several regions for advanced urothelial cancer and is being further studied across earlier and later stages of bladder disease.

Merck & Co., Inc. (MRK) Gains FDA Priority Review for KEYTRUDA Regimen in Muscle-Invasive Bladder Cancer

Separately, it was reported on April 7 that on March 25, Merck & Co., Inc. (NYSE:MRK) announced the initiation of a cash tender offer, through a subsidiary, to acquire all outstanding shares of Terns Pharmaceuticals at $53.00 per share in cash. The offer follows a previously disclosed definitive agreement between the companies. If completed, Terns would become a wholly owned subsidiary of Merck.

The transaction requires more than 50% of shares to be tendered, regulatory clearance under antitrust rules, and other customary closing conditions. The offer is set to expire on May 4, 2026, unless extended. Merck has filed formal tender documentation with the SEC, and Terns’ board has recommended that shareholders accept the offer and tender their shares. The deal is expected to close in the second quarter of 2026.

Merck & Co., Inc. (NYSE:MRK) is a global pharmaceutical company founded in 1891 and based in Rahway, New Jersey. It develops medicines, vaccines, and biologic therapies, and is a leader in oncology and infectious disease treatments.

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