WINREVAIR (sotatercept-csrk) - (HYPERION)

August 4, 2026: Merck & Co., Inc. reported multiple catalyst updates across its pipeline and regulatory portfolio. LIPFENDRA was described as the first FDA-approved oral PCSK9 inhibitor for LDL-C reduction in adults with hypercholesterolemia; it is also under EMA and China NMPA review, with the CORALreef Outcomes trial ongoing.

In oncology, Merck said KEYNOTE-C93 met its primary PFS endpoint for certain dMMR advanced/recurrent endometrial cancer patients, and TroFuse-005 (sac-TMT1) met OS and PFS endpoints in advanced/recurrent endometrial cancer after platinum and anti-PD-1/L1; Merck called it the first TROP2 ADC to improve both OS and PFS in this setting. Regulatory milestones ahead include WELIREG’s LITESPARK-011 PDUFA on October 4, 2026, and ifinatamab deruxtecan’s IDeate-Lung01 PDUFA on October 10, 2026. Merck also cited FDA/EC approvals for multiple KEYTRUDA-based regimens, including combinations with WELIREG, sacituzumab govitecan, and enfortumab vedotin.

In immunology, tulisokibart posted positive topline Phase 3 ATLAS-UC induction-only results in moderately to severely active ulcerative colitis; Phase 3 primary completion is expected in August 2026, with detailed Phase 2 HS data to be presented at an ESMO investor event on October 26, 2026.

In infectious disease, Phase 3 ISLEND-1/2 results for islatravir/lenacapavir were positive in virologically suppressed HIV, supporting potential once-weekly oral treatment; islatravir/ulonivirine showed positive Phase 2b maintenance data and is moving to Phase 3. MK-1406 completed Phase 3 ANCHOR enrollment in the Southern Hemisphere, with a second Northern Hemisphere flu season planned; approval is still anticipated in 2029. CAPVAXIVE received an FDA expanded indication for at-risk children and adolescents aged 2-17. Ophthalmology candidate remigromig has Phase 3 BRUNELLO primary completion due in September 2026. Merck also said it completed the acquisition of Terns Pharmaceuticals, adding MK-4208 for chronic myeloid leukemia.