Tonix Pharmaceuticals Announces Positive Minutes from Type C FDA Meeting to Discuss Adaptive Phase 2 Field Study of TNX-4800, a Human, anti-OspA Monoclonal Antibody, to Prevent Lyme Disease in the U.S.
Tonix Pharmaceuticals announced it received positive minutes from a Type C FDA meeting on its adaptive Phase 2 field study of TNX-4800, a human anti-OspA monoclonal antibody intended to prevent Lyme disease in the U.S. The company said FDA alignment on key study-design elements supports its planned start of the Phase 2 study in the first quarter of 2027.
Why it matters — FDA alignment on the study design clears a regulatory path for Tonix's Lyme disease prevention candidate, TNX-4800, to advance toward its planned Phase 2 start in early 2027.