Tonix Pharmaceut Stock Price, News & Analysis

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.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will participate in two virtual events: the H.C. Wainwright BioConnect Conference from January 10-13, 2022, and the Biotech Showcase from January 10-12 & 17-19, 2022. Presentations will be available on demand starting January 10, and investors can arrange virtual meetings during the Showcase. Tonix focuses on developing therapeutics for immunology and central nervous system conditions, including COVID-19-related products.

Tonix Pharmaceuticals has announced an exclusive collaboration with Kansas State University to develop a novel zinc nanoparticle (ZNP) mRNA COVID-19 vaccine, TNX-3700, which aims to enhance temperature stability during storage and transport. This new technology could eliminate the need for ultra-cold chain logistics traditionally required by lipid-nanoparticle (LNP) based vaccines. By improving deployment capabilities, TNX-3700 may facilitate global vaccination efforts against SARS-CoV-2. The collaboration aligns with pandemic preparedness goals.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced its addition to the Nasdaq Biotechnology Index, effective December 20, 2021. The Index tracks biotechnology and pharmaceutical securities listed on Nasdaq. Tonix focuses on developing therapeutics for various conditions, including COVID-19 related products and CNS disorders. Key candidates in their portfolio include TNX-102 SL, TNX-1300, and TNX-1800. However, the company faces risks such as regulatory delays and the need for further financing, which could impact development timelines.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has received FDA clearance for its Investigational New Drug (IND) application to initiate a first-in-human clinical study for TNX-2100, a skin test designed to measure T cell immunity to SARS-CoV-2. The study is expected to commence in Q1 2022. Dr. Seth Lederman emphasized the test's potential to offer personalized vaccine booster recommendations and reduce healthcare costs. Tonix is also developing TNX-1800, a live virus vaccine for COVID-19, aiming to begin Phase 1 trials in the second half of 2022.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced a research collaboration with Columbia University to develop TNX-1700, a recombinant trefoil factor family 2 (rTFF2) therapeutic for gastric and colorectal cancers. This partnership aims to enhance anti-PD1 checkpoint inhibitor therapy efficacy. The studies, led by Timothy Wang, M.D., will explore rTFF2's role in detoxifying the tumor microenvironment to activate CD8+ T cells and limit cancer cell immune evasion. Recent U.S. patent claims strengthen Tonix's position in this innovative treatment approach.