Tonix Pharmaceut Stock Price, News & Analysis

Tonix Pharmaceuticals (Nasdaq: TNXP) has secured an exclusive license from Columbia University for developing two monoclonal antibodies (mAbs) aimed at treating and preventing SARS-CoV-2 infections. This decision strengthens Tonix's COVID-19 therapeutic pipeline, particularly for immunocompromised individuals at heightened risk for severe illness. Following the FDA's removal of emergency use authorizations for existing mAb products, TNX-3600 (fully human mAbs) and TNX-4100 (murine mAbs) could provide essential treatment options. These mAbs are poised to neutralize a wider range of SARS-CoV-2 variants and are developed using advanced antibody generation technologies.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced promising preclinical results for its vaccine TNX-801 against monkeypox, demonstrating full protection in non-human primates. This study, published in the journal Viruses, indicates that eight out of eight vaccinated macaques achieved sterilizing immunity against a lethal monkeypox virus challenge. The company plans to initiate a Phase 1 trial for TNX-801 in the latter half of 2023, focusing on protecting against both monkeypox and smallpox. The vaccine is a live virus based on horsepox, designed for single-dose administration and favorable for large-scale production.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has announced the enrollment of the first participant in its Phase 2 PREVENTION study for TNX-1900, an intranasal formulation of oxytocin aimed at preventing chronic migraines. This double-blind, placebo-controlled study will enroll 300 participants across 25 U.S. sites, with results from an interim analysis expected in Q4 2023. Chronic migraines affect approximately four million people in the U.S., and TNX-1900 is designed to provide a novel treatment option by inhibiting pain signaling mechanisms. The study aims to address an unmet need for effective migraine prevention therapies.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will participate in the BIO CEO & Investor Conference from February 6-9, 2023. A pre-recorded presentation will be available to registered attendees on the conference website. Tonix focuses on developing treatments for diseases, with key candidates including TNX-102 SL in Phase 3 for fibromyalgia and Long COVID, TNX-1300 for cocaine intoxication, and TNX-601 ER for major depressive disorder. The company’s diverse pipeline includes products targeting CNS, rare diseases, immunology, and infectious diseases, with several studies expected to initiate in 2023.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the acquisition of Healion Bio, Inc., including its next-generation antiviral technology assets. This includes TNX-3900, a series of oral antiviral agents with a novel host-directed mechanism that inhibits cathepsin proteases, essential for viral infection, particularly against SARS-CoV-2. CEO Seth Lederman highlighted the potential of TNX-3900 as a broad-spectrum antiviral, usable as both monotherapy and in combination with other antivirals. The acquisition is expected to enhance Tonix's drug development capabilities at its Frederick, MD facility, aiming to advance TNX-3900 into clinical trials.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has announced a sponsored research agreement with the University of Maryland, Baltimore, to investigate the prevention of heart xenograft rejection using TNX-1500, a monoclonal antibody targeting CD40-ligand. Preclinical studies will use genetically-modified porcine hearts from Revivicor, Inc. A positive outcome could support an IND application and further human clinical trials. TNX-1500, designed to reduce thrombosis risk, may play a crucial role in preventing organ rejection. A Phase 1 study is anticipated to initiate in Q2 2023.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced preliminary results from a recent presentation on migraine treatments at the HCOP Winter Conference. The data indicate that magnesium enhances oxytocin’s analgesic effects and that intranasal oxytocin is effectively delivered to the trigeminal ganglia in humans, a key area related to migraines. Additionally, it was discovered that oxytocin receptors co-express with CGRP in human trigeminal neurons. Notably, sex differences were identified in oxytocin potency, with findings suggesting that females may respond better to oxytocin treatments. Tonix received FDA clearance for a Phase 2 study of TNX-1900, set to start enrollment in Q1 2023.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced it regained compliance with Nasdaq’s minimum bid price requirement, closing at or above $1.00 per share for 10 consecutive days. This compliance ensures continued listing on The Nasdaq Capital Market. Tonix is a clinical-stage biopharmaceutical company focused on developing therapeutics across various areas, including CNS, rare diseases, immunology, and infectious diseases. Key candidates include TNX-102 SL for fibromyalgia and Long COVID, TNX-1300 for cocaine intoxication, and TNX-801 for smallpox and monkeypox. Interim data for various studies is expected throughout 2023.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced an oral presentation by Dr. Tom Hobman at the 2nd Wnt & β-catenin Targeted Drug Development Conference on January 26, 2023. The presentation, titled “Targeting the Wnt/β-catenin pathway as a broad-spectrum antiviral strategy,” highlighted research on Wnt/β-catenin signaling pathway inhibitors as potential broad-spectrum antivirals against SARS-CoV-2. The CEO emphasized the need for such therapeutics to combat future pandemics. Tonix's lead candidate, TNX-102 SL, is in mid-Phase 3 for fibromyalgia, with interim data expected in mid-2023, further underlining their commitment to developing innovative therapies.