On Monday, October 13, 2025, the U.S. Food and Drug Administration cleared the Elecsys pTau181 blood test developed by Roche Diagnostics in partnership with Eli Lilly. The test is the first FDA‑cleared blood‑based biomarker for the initial assessment of Alzheimer’s disease and other causes of cognitive decline. The approval positions Lilly as a key player in the emerging Alzheimer’s diagnostics market.
In a separate regulatory milestone, South Africa’s Medicines and Healthcare Regulatory Authority granted approval for Eli Lilly’s diabetes and obesity drug Mounjaro to be marketed for chronic weight management. The approval was announced on Monday, October 13, 2025, and expands Lilly’s presence in the African market. Mounjaro’s established efficacy in weight loss and glycemic control makes it a valuable addition to South Africa’s therapeutic options.
Together, the FDA clearance of a diagnostic test and the South African market entry for Mounjaro represent significant revenue opportunities for Lilly. The blood‑test approval opens a new diagnostic revenue stream, while the Mounjaro launch expands Lilly’s global footprint and diversifies its product portfolio. These developments reinforce Lilly’s strategy of leveraging its scientific expertise to capture new markets.
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