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Merck Secures First Oral PCSK9 Inhibitor, Boosts Q1 2026 Earnings and Expands Oncology Pipeline
Merck’s latest triumph—an FDA nod for its first oral PCSK9 inhibitor—comes on the heels of a stronger‑than‑expected first‑quarter earnings report. On July 16 2026, the U.S. Food and Drug Administration approved Lipfendra (enlicitide decanoate), giving Merck the first U.S. FDA‑approved oral PCSK9 blocker for adults with high LDL‑C.
The approval follows the company’s Q1 2026 earnings release on April 30, 2026, which showed worldwide sales of $16.3 billion, up 5 % from the same period in 2025. In that release, Merck highlighted the acquisition of Terns Pharmaceuticals and the progress of its oncology pipeline.
In a Merck news release, Dean Y. Li, president of Merck Research Laboratories, called the approval a "pivotal moment" that delivers the first U.S. FDA‑approved oral PCSK9 inhibitor to patients already on statins who need further LDL‑C reduction. The tablet is priced at $315 per month, positioning it below branded injectable PCSK9 therapies but above generic statins.
Merck’s Q1 2026 earnings presentation underscored continued strength in oncology and animal health. Oncology contributed the largest share of sales growth, while animal‑health products added a steady stream of revenue. The company also announced the launch of new products and the ongoing development of pipeline candidates, including ifinatamab deruxtecan.
Ifinatamab deruxtecan, a novel antibody–drug conjugate, received priority review from the FDA on April 13 2026 for the treatment of extensive‑stage small‑cell lung cancer. Merck’s pipeline also includes other agents that have earned breakthrough therapy designation or are in late‑stage trials.
In March 2026, Merck announced the acquisition of Terns Pharmaceuticals, a hematology‑focused company, for approximately $6.7 billion in cash. The deal gives Merck access to TERN‑701, an oral therapy for chronic myeloid leukemia. A Merck spokesperson said the acquisition "reflects the company’s continued focus on science‑driven, value‑enhancing business development aimed at bringing meaningful innovation to patients."
Merck’s oncology strategy also seeks to mitigate the impending loss of patent protection for its flagship immunotherapy, Keytruda (pembrolizumab). Keytruda’s patent is expected to expire in 2028, creating a potential revenue risk. The acquisition of Terns and the development of new oncology candidates are intended to offset that risk.
The company’s Q1 2026 financials also highlighted a 5 % revenue increase, driven by oncology and animal health. Merck projects 2026 revenue between $65.8 billion and $67 billion, but cautions that regulatory outcomes and new product launches remain potential risks.
Merck’s recent developments—FDA approval of the first oral PCSK9 inhibitor, a sizable acquisition in hematology, and continued progress in oncology—illustrate the company’s strategy to diversify its revenue base and strengthen its portfolio ahead of Keytruda’s patent expiry. Investors will be watching the company’s upcoming earnings releases, regulatory decisions on its pipeline candidates, and the commercial performance of Lipfendra.
The next earnings call will take place on June 15 2026, and the FDA is expected to provide further guidance on the commercial launch of Lipfendra in the coming months. Merck’s strategy to expand its cardiometabolic and oncology offerings remains a key focus as it navigates a competitive pharmaceutical landscape.
The approval follows the company’s Q1 2026 earnings release on April 30, 2026, which showed worldwide sales of $16.3 billion, up 5 % from the same period in 2025. In that release, Merck highlighted the acquisition of Terns Pharmaceuticals and the progress of its oncology pipeline.
In a Merck news release, Dean Y. Li, president of Merck Research Laboratories, called the approval a "pivotal moment" that delivers the first U.S. FDA‑approved oral PCSK9 inhibitor to patients already on statins who need further LDL‑C reduction. The tablet is priced at $315 per month, positioning it below branded injectable PCSK9 therapies but above generic statins.
Merck’s Q1 2026 earnings presentation underscored continued strength in oncology and animal health. Oncology contributed the largest share of sales growth, while animal‑health products added a steady stream of revenue. The company also announced the launch of new products and the ongoing development of pipeline candidates, including ifinatamab deruxtecan.
Ifinatamab deruxtecan, a novel antibody–drug conjugate, received priority review from the FDA on April 13 2026 for the treatment of extensive‑stage small‑cell lung cancer. Merck’s pipeline also includes other agents that have earned breakthrough therapy designation or are in late‑stage trials.
In March 2026, Merck announced the acquisition of Terns Pharmaceuticals, a hematology‑focused company, for approximately $6.7 billion in cash. The deal gives Merck access to TERN‑701, an oral therapy for chronic myeloid leukemia. A Merck spokesperson said the acquisition "reflects the company’s continued focus on science‑driven, value‑enhancing business development aimed at bringing meaningful innovation to patients."
Merck’s oncology strategy also seeks to mitigate the impending loss of patent protection for its flagship immunotherapy, Keytruda (pembrolizumab). Keytruda’s patent is expected to expire in 2028, creating a potential revenue risk. The acquisition of Terns and the development of new oncology candidates are intended to offset that risk.
The company’s Q1 2026 financials also highlighted a 5 % revenue increase, driven by oncology and animal health. Merck projects 2026 revenue between $65.8 billion and $67 billion, but cautions that regulatory outcomes and new product launches remain potential risks.
Merck’s recent developments—FDA approval of the first oral PCSK9 inhibitor, a sizable acquisition in hematology, and continued progress in oncology—illustrate the company’s strategy to diversify its revenue base and strengthen its portfolio ahead of Keytruda’s patent expiry. Investors will be watching the company’s upcoming earnings releases, regulatory decisions on its pipeline candidates, and the commercial performance of Lipfendra.
The next earnings call will take place on June 15 2026, and the FDA is expected to provide further guidance on the commercial launch of Lipfendra in the coming months. Merck’s strategy to expand its cardiometabolic and oncology offerings remains a key focus as it navigates a competitive pharmaceutical landscape.
