TinyGemsBreaks – Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) Receives FDA Feedback for Lyme Disease Prevention Study
Tonix Pharmaceuticals (NASDAQ: TNXP) announced it received official minutes from a Type C meeting with the U.S. Food and Drug Administration supporting plans for an adaptive Phase 2 field study of TNX-4800, its long-acting anti-OspA monoclonal antibody candidate designed to prevent Lyme disease. The planned randomized, placebo-controlled study is expected to enroll approximately 3,300 adults over two Lyme disease seasons to evaluate prevention through six months after dosing, with manufacturing of investigational product on track for delivery to study sites in the first quarter of 2027. Tonix said TNX-4800 is being developed as a seasonal immunopreventative administered as two subcutaneous…

