Tonix Pharmaceuticals Holding Corp. announced updates on the development of TNX-4800, a long-acting monoclonal antibody designed for the seasonal prevention of Lyme disease. The company plans to meet with the FDA in 2026 to discuss Phase 2/3 clinical development options, including the use of a controlled human infection model $(CHIM)$ that mimics natural infection with Borrelia-infected ticks. Tonix expects to have the investigational product available for clinical trials in early 2027. TNX-4800 is intended to provide near-immediate immunity after a single administration and could serve as an annual prophylactic treatment for people at risk of Lyme disease. The results have not yet been presented; the company is currently outlining its future clinical development plans.

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