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Merck & Co.: Two Catalysts Already Delivered. Three More Before October Ends.

Summary

  • I am rating Merck a BUY because Merck's pipeline is not a future promise. It is actively delivering ahead of schedule, with the FDA approving KEYTRUDA plus Padcev for all muscle invasive bladder cancer patients on July 10, 2026, five weeks ahead of the original target date. And Lipfendra (enlicitide) on July 16 as the world's first oral PCSK9 inhibitor, while three additional FDA decisions remain on the calendar for September and October 2026. 


  • Growth will be driven by Keytruda's continued label expansion across 44 approved indications. Complemented by WINREVAIR's 88% quarterly growth to $525 Mn, Animal Health's 13% revenue increase, and incremental contributions from over 20 new product launches now underway. 


  • I believe that Merck is trading at a price that reflects 2028 patent cliff anxiety rather than a pipeline that has already delivered one approval ahead of schedule in July 2026 alone, with three more decisions before year end. 


  • The primary risk is Keytruda's US exclusivity pressure beginning 2028. This is partially addressed by the subcutaneous Keytruda QLEX formulation, which Merck is using to transition patients onto a version biosimilars cannot immediately replicate after 2028.


Merck office building with glass skybridge over a driveway, trees and parked cars under a cloudy blue sky.
Source: merck

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