Tonix Pharmaceuticals Holding Corp. - TNXP STOCK NEWS

Tonix Pharmaceuticals (Nasdaq: TNXP) has initiated the Phase 2 PREVAIL study of TNX-102 SL for Long COVID treatment, targeting patients with fibromyalgia-like symptoms. The study aims to enroll approximately 470 patients over 14 weeks, assessing changes in pain intensity, sleep disturbance, and fatigue. Preliminary findings reveal over 40% of Long COVID patients experience multi-site pain, with a concerning opioid use rate of 36%. Interim results are expected in the first half of 2023, as no approved treatments currently exist for Long COVID.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will present at the Virtual Q3 Investor Summit on August 16, 2022, at 9:30 a.m. ET. Investors can schedule meetings with management during the conference. The presentation will be available via webcast.

Tonix is a clinical-stage biopharmaceutical company focused on developing therapies for CNS disorders, rare diseases, and infectious diseases. Their lead candidate, TNX-102 SL, is in mid-Phase 3 development for fibromyalgia and also targets Long COVID. Additional products are in various stages of development for other conditions.

Tonix Pharmaceuticals announced the receipt of a Cooperative Agreement grant from the National Institute on Drug Abuse (NIDA) to develop TNX-1300, a treatment for cocaine intoxication. This follows the drug's Breakthrough Therapy designation by the FDA, paving the way for a Phase 2 clinical trial expected to start in Q4 2022. Cocaine intoxication, which saw over 24,900 overdose deaths in 2021 in the U.S., currently lacks specific treatments. TNX-1300 aims to target the cause of intoxication, offering potential advantages over existing therapies.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced the issuance of U.S. Patent 11,389,473 on July 19, 2022, for its intranasal magnesium-containing oxytocin formulations targeting migraine treatment, valid until 2036. With FDA IND clearance, a Phase 2 study for TNX-1900, aimed at chronic migraine prevention, is scheduled to commence in the second half of 2022. Approximately four million Americans suffer from chronic migraine, presenting a significant market opportunity for Tonix's innovative treatment approach.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has announced a collaboration with the Kenya Medical Research Institute (KEMRI) to initiate a Phase 1 clinical study for TNX-801, a vaccine targeted at monkeypox and smallpox, expected to start in the first half of 2023. The partnership responds to the World Health Organization's declaration of monkeypox as a global health emergency. TNX-801 is a live virus vaccine with reduced virulence and aims to provide durable immunity without requiring ultra-cold storage, potentially addressing the growing monkeypox issue in Africa.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the appointment of Sina Bavari, Ph.D. as Executive Vice President, Infectious Disease Research and Development. Dr. Bavari will lead the company's infectious disease pipeline, overseeing operations at the Frederick, MD R&D Center. With a strong background in managing infectious disease programs, he aims to expedite development in vaccines for monkeypox, smallpox, and COVID-19. Tonix also highlighted its ongoing clinical trials for various therapeutic candidates, reinforcing its commitment to addressing critical health issues globally.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the development of TNX-601 ER, an abuse-deterrent, naloxone-free formulation of tianeptine for major depressive disorder (MDD). This once-daily tablet is bioequivalent to existing three-times-a-day antidepressants available in Europe. Tonix plans to initiate a Phase 2 study in Q1 2023, pending FDA approval of its IND application. Tianeptine has shown potential for neuroplasticity enhancement, differentiating its action from traditional antidepressants.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced its participation in the World Orphan Drug Congress USA 2022, scheduled for July 11-13. CEO Seth Lederman will present on TNX-2900, an intranasal therapy aimed at treating hyperphagia in adolescents and young adults with Prader-Willi syndrome, on July 11 at 2:00 p.m. ET. Tonix's clinical-stage pipeline includes investigational therapies for various conditions, such as fibromyalgia and Long COVID. The company continues to focus on developing therapeutics across multiple disease areas, enhancing its visibility in the biopharmaceutical sector.

Tonix Pharmaceuticals (TNXP) announced a new Phase 2 clinical trial design for TNX-1300, an innovative treatment for cocaine intoxication. This single-blind, placebo-controlled study aims to include women and patients who received naloxone to enhance enrollment. TNX-1300, a cocaine esterase, has shown efficacy in previous trials and has received Breakthrough Therapy designation from the FDA, providing potential for 12 years of market exclusivity upon approval. With 505,000 annual emergency room visits related to cocaine use in the U.S., the company believes TNX-1300 could significantly address this public health issue.