Tonix Pharmaceuticals Holding Corp. - TNXP STOCK NEWS

Tonix Pharmaceuticals (Nasdaq: TNXP) has commenced its Phase 3 RESILIENT study for TNX-102 SL, targeting fibromyalgia management. This pivotal study follows positive results from the earlier Phase 3 RELIEF study, which showed significant efficacy (p=0.010), while the subsequent RALLY study did not achieve significance (p=0.115). An interim analysis of RESILIENT is anticipated in Q1 2023. The investigational TNX-102 SL aims to provide a non-addictive treatment option for fibromyalgia, a condition afflicting an estimated 6-12 million adults in the U.S.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced FDA clearance for a Phase 2 clinical trial of TNX-102 SL, targeting Long COVID patients with symptoms overlapping fibromyalgia. This trial will evaluate the efficacy of TNX-102 SL, a sublingual formulation, in treating multi-site pain associated with Long COVID. The 14-week study aims to enroll approximately 470 patients across 30 sites, with results anticipated to inform on pain intensity changes. Long COVID affects over 30% of those recovering from COVID-19, presenting a significant health concern.

Tonix Pharmaceuticals (Nasdaq: TNXP) has announced a new preclinical research agreement with Kansas State University to advance the development of TNX-2300, a live virus vaccine aimed at protecting against COVID-19. This vaccine uses a bovine parainfluenza virus vector platform and aims to enhance T cell immunity through the co-expression of the CD40-ligand. Initial studies show that this vaccine could elicit strong and durable immunity. The research is directed by Dr. Waithaka Mwangi, and an exclusive license for the vaccine's clinical and commercial use has been granted to Tonix.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that its CEO Seth Lederman will present at the 2022 Virtual Growth Conference, hosted by Maxim Group LLC from March 28-30, 2022. The presentations will be available on-demand through the conference portal. Tonix is focused on developing therapeutics for conditions such as fibromyalgia and Long COVID, with its lead candidates, TNX-102 SL and TNX-1300, expected to enter new phases of clinical trials in the first half of 2022. More information can be found on Tonix's website.

Tonix Pharmaceuticals announced that TNX-102 SL did not achieve statistical significance in reducing fibromyalgia pain compared to placebo in the Phase 3 RALLY study (p=0.115). This outcome contrasts with the positive Phase 3 RELIEF study (p=0.010). The RALLY study saw a significant increase in adverse event-related discontinuations, with a 79% rise in the TNX-102 SL group. Despite these findings, TNX-102 SL demonstrated tolerability similar to prior studies, leading to plans for the upcoming RESILIENT study aimed at further evaluating the treatment's efficacy.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) reported a net loss of $29.6 million, or $0.07 per share, for Q4 2021, up from $17.0 million in Q4 2020. Annual losses totaled $92.3 million, or $0.26 per share, compared to $52.2 million in 2020. Cash and equivalents reached approximately $179 million by year-end 2021. Key activities include the advancement of its immunology and CNS pipeline with several clinical trials planned for 2022, including a Phase 2 study for TNX-102 SL targeting fibromyalgia and PTSD. The company also received orphan-drug designation for TNX-2900 for Prader-Willi syndrome.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) appointed Jeffrey Rosenfeld, Ph.D. as Executive Director, Genomics and Bioinformatics. He will lead pharmacogenomics efforts using artificial intelligence and mathematical modeling to analyze clinical trial outcomes. Seth Lederman, M.D., CEO, praised Dr. Rosenfeld's expertise, suggesting his leadership will bolster drug development success. Dr. Rosenfeld has over 15 years of experience in genomics, having worked on various genetic projects and founded Genome Liberty. Tonix continues to advance its clinical pipeline, focusing on CNS and infectious disease therapeutics.

Tonix Pharmaceuticals (Nasdaq: TNXP) has announced a Phase 2 clinical trial for TNX-1900, aimed at treating binge eating disorder, a condition affecting 2.8 million American adults. Collaborating with Massachusetts General Hospital, the trial will evaluate 60 patients and is set to begin in the second half of 2022. Chief Executive Officer Seth Lederman highlighted the significant treatment gap for this disorder. Previous research indicates oxytocin, the active component in TNX-1900, may help reduce food intake by altering neural pathways involved in eating behavior.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that the FDA granted Orphan-Drug Designation for its investigational drug TNX-2900, aimed at treating Prader-Willi syndrome. This designation highlights an urgent medical need and positions TNXP for development incentives like tax credits and potential market exclusivity. The company is working with Inserm Transfert to study oxytocin's effects in a mouse model of the syndrome, which causes severe eating disorders and obesity. There is currently no approved treatment for the condition.