MRK · 10-Q · 2026Q3 · Full report

Product / Drug Pipeline Progress

Merck & Co., Inc. · 2026-11-04 · Importance 31 · Surprise 42 · In source text

Merck reported multiple late-stage candidates under regulatory review, including Lipfendra (MK-0616) in the EU, Japan, and China for hypercholesterolemia or dyslipidemia, and Idvynso (MK-8591A) in the EU and U.S. for HIV-1. Enflonsia is under review in the U.S., EU, and Japan for expanded RSV prevention in higher-risk children under two; Keytruda and Welireg have additional cancer indications under review in Japan and the EU. The company also disclosed that the U.S. application for investigational B7-H3 ADC I-DXd in previously treated extensive-stage small cell lung cancer was withdrawn after FDA discussions, while enrollment continues in its Phase 3 trial against physician’s-choice chemotherapy. The pipeline listing includes Phase 3 programs across oncology, HIV, immunology, respiratory disease, and vaccines, including calderasib for colorectal and non-small cell lung cancer and tulisokibart for Crohn’s disease and ulcerative colitis.

Key facts

• The U.S. HHS Secretary gave notice on June 29, 2026 that the declaration supporting Lagevrio's EUA will terminate effective June 29, 2027; Merck worked with FDA on disposition of U.S. Lagevrio by that date. source
• FDA approved Idvynso in April 2026 for adults with HIV-1 infection who are virologically suppressed on a stable regimen and meet specified treatment-history and resistance criteria; Japan approved it in March 2026. source
• The U.S. BLA for ifinatamab deruxtecan in previously treated extensive-stage small cell lung cancer was voluntarily withdrawn after FDA discussions indicated the submitted data did not satisfy accelerated-approval requirements. source
• The FDA set June 15, 2027, as the PDUFA date for sac-TMT's priority-review application for previously treated endometrial cancer. source
• The FDA selected sac-TMT for a Commissioner's National Priority Voucher in December 2025, and Merck is discussing the voucher with FDA and hopeful for approval before the June 15, 2027 PDUFA date. source
• Idvynso is under U.S. review to expand its indication to certain treatment-naive adults with HIV-1; the FDA set an April 22, 2027 PDUFA date. source
• Enflonsia is under review in the U.S., EU, and Japan to expand prevention of RSV lower respiratory tract disease to at-risk children under two through their second RSV season; the U.S. PDUFA date is March 22, 2027. source
• FDA approved an expanded Capvaxive indication in June 2026 for certain children and adolescents aged 2 through 17; the EC approved a similar expansion in April 2026. source

Impact estimates