Core Insights - Tonix Pharmaceuticals is initiating an open-label Phase 2 study of TNX-1500 to evaluate its safety and activity in kidney transplant recipients, with the study expected to start in the first half of 2026 [1][2] - TNX-1500 is designed to reduce the exposure to calcineurin inhibitors (CNIs) and improve transplant outcomes by selectively targeting cell-associated CD40L [1][2] - The study will assess the incidence of adverse events and secondary endpoints such as graft survival and renal function [2][3] Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with a focus on developing therapies for various conditions, including central nervous system disorders, immunology, and infectious diseases [6] - The company has received FDA approval for Tonmya™, a treatment for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [6] - Tonix's development pipeline includes candidates for rare diseases and infectious diseases, such as TNX-2900 for Prader-Willi syndrome and TNX-801, a vaccine for mpox and smallpox [6] Clinical Development - The Phase 1 study of TNX-1500 demonstrated safety and tolerability, supporting its use in the upcoming Phase 2 trial [2][3] - The Phase 2 trial will enroll five adult kidney transplant recipients and will include a regimen of TNX-1500, tacrolimus, and corticosteroids [2] - The primary endpoint of the study is the incidence of adverse and serious adverse events at 12 months, with secondary endpoints focusing on graft survival and renal function [2][3]