Tonix Pharmaceut Stock Price, News & Analysis

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman will hold one-on-one meetings at the BIO-Europe Conference in Leipzig, Germany, from October 24-26, 2022. The conference presentation will be available to registered participants. Tonix focuses on developing therapeutics for CNS, rare diseases, immunology, and infectious diseases. Their lead candidate, TNX-102 SL, is in mid-Phase 3 trials for fibromyalgia and also targets Long COVID. Upcoming studies include TNX-1300 for cocaine intoxication and TNX-601 ER for major depressive disorder.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced FDA clearance for its IND application for TNX-601 ER, an extended-release tablet for major depressive disorder (MDD). The Phase 2 clinical trial is set to begin in Q1 2023, evaluating the efficacy and safety of the once-daily formulation. Tianeptine, already available in other countries for over 30 years, offers a unique mechanism of action distinct from traditional antidepressants, potentially exhibiting fewer side effects. TNX-601 ER also incorporates abuse-deterrent properties, aimed at minimizing misuse risks associated with tianeptine.

Tonix Pharmaceuticals (Nasdaq: TNXP) presented a study at the IASP 2022 World Congress on Pain about Long COVID symptoms. The research found that approximately 40% of Long COVID patients experience fibromyalgia-like multi-site pain. Furthermore, 50% of those with multi-site pain and sleep disturbances are using opioids for relief, highlighting a significant public health concern. Tonix is developing TNX-102 SL as a non-opioid treatment for these patients, with ongoing Phase 2 trials expected to provide interim results in early 2023.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced promising results from studies on its TNX-1500 monoclonal antibody at the 29th International Congress of The Transplantation Society. The research demonstrated TNX-1500's effectiveness in preventing organ rejection in non-human primates, showing 'long-term rejection-free survival' for both allograft and xenograft transplants. The company plans to start a Phase 1 trial in the first half of 2023, indicating potential for TNX-1500 to address significant needs in organ transplant rejection treatment.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced three oral presentations at the 29th International Congress of The Transplantation Society (TTS 2022) from September 10-14, 2022, in Buenos Aires, Argentina. These presentations will showcase research on anti-CD154 antibody monotherapy and its potential to prolong organ allograft survival. The first presentation is scheduled for September 12, focusing on renal allograft survival. Subsequent presentations on cardiac allograft survival and kidney xenograft survival will take place on September 13 and 14, respectively.

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.