Tonix Pharmaceuticals Holding Corp - TNXP STOCK NEWS

Tonix Pharmaceuticals Holding Corp. (TNXP) announced that the U.S. FDA has cleared the Investigational New Drug (IND) application to support clinical development of TNX-2900, a proprietary magnesium-enhanced formulation of intranasal oxytocin, to treat Prader-Willi syndrome (PWS) in children and adolescents. The Phase 2 study approved by the IND is a dose-finding study involving approximately 36 PWS patients, and Tonix intends to seek a partner to advance TNX-2900 for PWS in clinical development.

Tonix Pharmaceuticals Holding Corp. (TNXP) announced that Tonix Management will present and host investor meetings at NobleCon 19 and the December Virtual Investor Summit. The company is a biopharmaceutical company focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix's development portfolio includes CNS, rare disease, immunology, and infectious disease product candidates. The company's lead development CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia, with topline data expected in late December 2023. The company's rare disease development portfolio includes TNX-2900 for the treatment of Prader-Willi syndrome. Tonix's immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. The company's infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the completion of the clinical phase of the Phase 3 registration-quality, double-blind, placebo-controlled RESILIENT1 study of TNX-102 SL2 (cyclobenzaprine HCl sublingual tablets) 5.6 mg for fibromyalgia management. The study achieved statistical significance (p=0.010) and showed a favorable adverse-event (AE) related discontinuation rate of 4.8% compared to prior studies. TNX-102 SL is a non-opioid analgesic medication designed to improve sleep quality and other fibromyalgia symptoms.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced enrollment of the first participant in a Phase 2 study of TNX-1900 for improving bone health in children with autism spectrum disorder (ASD). The study aims to investigate the efficacy and safety of TNX-1900 as a novel therapeutic agent to increase bone density and improve bone structure and strength in children with ASD.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced financial results for Q3 2023, expecting topline results for Phase 3 fibromyalgia study and Phase 2 chronic migraine study by year end, along with progress in obtaining external support for clinical trials and revenue from marketed acute migraine products.

Tonix Pharmaceuticals announced that the National Institute of Allergy and Infectious Diseases (NIAID) will conduct a Phase 1 clinical trial with TNX-1800, their vaccine candidate for COVID-19. The trial is expected to start in the second half of 2024 and will assess safety and immunogenicity in approximately 60 healthy adult volunteers. NIAID will cover the full cost of the trial, while Tonix will supply the vaccine candidate.

Tonix Pharmaceuticals Holding Corp. announced topline results from the Phase 2 study of TNX-601 ER in patients with major depressive disorder. The study did not achieve statistical significance on the primary endpoint, and as a result, Tonix is discontinuing development of TNX-601 ER. The company expects topline data results in December 2023 for its Phase 2 study of TNX-1900 in chronic migraine and Phase 3 study of TNX-102 SL in fibromyalgia.

Tonix Pharmaceuticals announced data from two oral presentations at recent medical conferences on their drug TNX-1500, currently in Phase 1 development for the prevention of organ transplant rejection. The data showed promising results in preclinical studies using genetically engineered pig hearts in baboon transplants. Tonix is enrolling in a Phase 1 trial in healthy volunteers to support the development of TNX-1500 for the prevention of allograft rejection.

Tonix Pharmaceuticals completes clinical phase of Phase 2 study for TNX-1900 as a potential treatment for chronic migraines