WINREVAIR (sotatercept-csrk) - (HYPERION)

February 3, 2026: Merck & Co., Inc. (Rahway, N.J., USA) provided a Q4 2025 sales/earnings and pipeline update highlighting multiple clinical, regulatory, and business-development catalysts and upcoming milestones.

Key 2025 catalyst highlights:

• Cardiometabolic/Respiratory: Phase 3 enlicitide results from CORALreef Lipids and HeFH presented at AHA 2025; positive Phase 2 topline WINREVAIR in CpcPH due to HFpEF (details to be presented at ACC). EC approved WINREVAIR expanded indication for PAH (WHO FC II–IV) in combination with other PAH therapies based on Phase 3 ZENITH.
• Infectious Disease/HIV: Positive topline results for doravirine + islatravir in treatment-naïve adults with HIV-1.
• Oncology: FDA approval of KEYTRUDA and KEYTRUDA QLEX with enfortumab vedotin for perioperative treatment of cisplatin-ineligible MIBC (KEYNOTE-9051). Positive topline for KEYNOTE-B151 (met EFS, pCR, OS in cisplatin-eligible MIBC) and 5-year follow-up for intismeran autogene + KEYTRUDA (KEYNOTE-942). FDA granted Commissioner’s National Priority Vouchers for enlicitide and sac-TMT.

Business development:

• Completed acquisition of Cidara Therapeutics, adding MK-1406 (long-acting, strain-agnostic influenza prevention candidate); guidance includes an expected ~$9B related charge.

Upcoming catalysts (dates as listed):

• Oncology: KEYNOTE-B96 KEYTRUDA PDUFA Feb 20; KEYNOTE-B96 KEYTRUDA QLEX PDUFA Apr 14; detailed KEYNOTE-B152 and WELIREG (LITESPARK-011/-022) data at ASCO-GU.
• HIV: Doravirine/Islatravir PDUFA Apr 28; ISLEND-1/2 (islatravir/lenacapavir) Phase 3 PCDs in April.
• Immunology: tulisokibart Phase 2 ATHENA (SSc-ILD) PCD May; Phase 3 ATLAS (UC) PCD Aug.
• Cardiometabolic/Respiratory: WINREVAIR CADENCE (CpcPH due to HFpEF) and enlicitide CORALreef AddOn detailed results at ACC.
• Ophthalmology: HYPERION PDUFA Sept 21; MK-3000 BRUNELLO (DME) Phase 3 PCD Sept; MK-8748 RIOJA Phase 2 PCD April.