FDA Approves New Dosing Regimen for Eli Lilly's EBGLYSS

Novartis agreed in September 2025 to acquire Tourmaline Bio, Inc. for approximately $1.4 billion, with the IL-6 inhibitor pacibekitug as the central strategic asset. Novartis described pacibekitug as Phase III-ready and positioned it as a complement to its cardiovascular portfolio, gaining access to its global cardiovascular infrastructure, development capabilities, payer relationships and launch expertise. The deal follows positive topline results from the Phase II TRANQUILITY trial reported by Tourmaline Bio in May 2025, in which monthly dosing at 15 mg produced an hs-CRP reduction of more than 85% and 50 mg quarterly dosing achieved a reduction of more than 86%, with all treatment arms reaching p< 0.0001 compared with placebo and adverse event rates comparable to placebo. Pacibekitug is an investigational, long-acting fully human IgG2 monoclonal antibody that selectively binds to and neutralizes IL-6 signaling, designed for low-volume subcutaneous administration with an extended half-life that may support quarterly dosing. Originally developed by Pfizer Inc. for autoimmune diseases including Crohn's Disease and Systemic Lupus Erythematosus, the asset has since been repositioned for atherosclerotic cardiovascular disease, Chronic Kidney Disease with elevated inflammation, Thyroid Eye Disease and other inflammatory conditions. A new ResearchAndMarkets.com report forecasts pacibekitug sales and market size through 2034 across the seven major markets of the United States, EU4, the United Kingdom and Japan, covering cardiovascular disorders, Graves ophthalmopathy, kidney disorders and abdominal aortic aneurysm.