Merck posts Q3 2026 results with oncology approvals and new sac-TMT regulatory filing

Merck & Co. announced its third-quarter 2026 financial results on October 29, 2026, alongside a series of pipeline updates spanning oncology, vaccines, and other therapeutic areas.

In oncology, the U.S. FDA approved WELIREG plus Lenvima, developed with Eisai, for certain previously treated adult patients with advanced renal cell carcinoma that has a clear cell component, based on the Phase 3 LITESPARK-011 trial.¹ The company said this represents the first approved combination of an oral hypoxia-inducible factor-2 alpha inhibitor and a multi-targeted vascular endothelial growth factor tyrosine kinase inhibitor for these patients.¹

Also in October, the FDA accepted a Biologics License Application for sacituzumab tirumotecan (sac-TMT) for adult patients with endometrial cancer previously treated with platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor, based on the Phase 3 TroFuse-005 trial.¹ The FDA set a PDUFA date of June 15, 2027, though Merck said it is in discussions with the agency and is hopeful for an earlier approval.¹

In Europe, the European Commission approved KEYTRUDA plus Padcev as perioperative treatment for adults with resectable muscle-invasive bladder cancer, based on the Phase 3 KEYNOTE-B15 trial.¹ Separately, the companion ifinatamab deruxtecan BLA, developed with Daiichi Sankyo for previously treated extensive-stage small cell lung cancer, was voluntarily withdrawn.¹

On the infectious disease side, the FDA accepted a supplemental BLA for ENFLONSIA to expand its RSV indication to children under 2 at increased risk through a second RSV season, with a PDUFA date of March 22, 2027.¹ The FDA also accepted two supplemental applications for IDVYNSO covering treatment-naive HIV-1 patients and 96-week data in virologically suppressed adults, with a PDUFA date of April 22, 2027 for both.¹

On financials, total worldwide sales were $18.1 billion, up 5%, with KEYTRUDA/KEYTRUDA QLEX sales of $8.6 billion and WINREVAIR sales of $694 million, up 93%.¹ Merck now anticipates full-year 2026 sales between $66.8 billion and $67.3 billion¹ and expects full-year non-GAAP EPS between $2.77 and $2.82, a range that includes one-time charges of $3.62 per share for the Cidara acquisition, $2.31 per share for the Terns acquisition, and $0.12 per share tied to a global license agreement with SciBrunch.¹