Tonix Pharmaceut Stock Price, News & Analysis

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.

Tonix Pharmaceuticals (Nasdaq: TNXP) has entered a research agreement with Inserm Transfert and Aix-Marseille Université to study oxytocin in a mouse model of Prader-Willi syndrome, focusing on its effects on feeding behaviors. The company aims to develop TNX-2900, an intranasal oxytocin treatment for adults and adolescents with hyperphagia. Currently, there are no approved treatments for Prader-Willi syndrome. The collaboration hopes to enhance understanding of oxytocin's potential benefits. Tonix also holds patents for this technology, which provide potential market exclusivity through 2031.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that Seth Lederman, M.D., CEO, will participate virtually in the BIO CEO & Investor Conference from February 14-17, 2022. A pre-recorded presentation will be accessible to registered participants via the conference website, later available on Tonix's website. The company focuses on developing therapeutics for various diseases, including COVID-19. Its lead vaccine candidate, TNX-1800, aims to elicit a T cell response for COVID-19 protection, with a Phase 1 study expected in H2 2022.

Tonix Pharmaceuticals (NASDAQ: TNXP) announced the enrollment of the first participant in a dose-finding study for TNX-2100, aimed at measuring T cell immunity to SARS-CoV-2. This intradermal skin test could serve multiple purposes, including assessing vaccine protection durability and guiding booster vaccinations. It evaluates delayed-type hypersensitivity (DTH) responses, which are crucial for assessing T cell immunity. The study will involve 90 adult subjects across three cohorts, with topline data anticipated in the first half of 2022.