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Tonix Pharmaceuticals Holding Corp. (symbol: TNXP) is a pioneering biopharmaceutical company dedicated to developing, licensing, and commercializing innovative therapeutics to treat and prevent human diseases. With a focus on central nervous system (CNS) disorders, Tonix is at the forefront of addressing major public health challenges.
One of Tonix's key projects is Tonmya, aimed at treating PTSD, which is currently in advanced stages of development. Additionally, the company is working on TNX-601 (tianeptine oxalate), a daytime treatment for PTSD, and TNX-801, a synthetic version of the horsepox virus, intended as a potential smallpox vaccine, both at the pre-IND (Investigational New Drug) application stage.
The company’s immunology development portfolio includes TNX-1500, a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154), being developed to prevent allograft rejection and treat autoimmune diseases. This portfolio demonstrates Tonix's commitment to addressing both organ transplant rejection and autoimmunity, as well as cancer.
Tonix’s mission to alleviate suffering extends beyond CNS disorders and immunology, as it is also exploring therapeutic solutions for rare and infectious diseases. Their dedication to research and innovation has established partnerships with reputable institutions, such as Massachusetts General Hospital, ensuring that their projects are backed by cutting-edge science and expertise.
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Tonix Pharmaceuticals presented new data from its Phase 3 RESILIENT trial of Tonmya at the ASCP Annual Meeting, highlighting improvements in depressive symptoms among fibromyalgia patients. Tonmya showed a significant improvement in Beck Depression Inventory-II scores compared to placebo, with a nominal p-value of 0.005 by Week 14. Additional post-hoc analyses indicated improvements in anxiety, memory, and energy levels. The company plans to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya's use in fibromyalgia management.
Tonix Pharmaceuticals announced two poster presentations at the ASCP Annual Meeting, highlighting TNX-102 SL in treating Long COVID and Acute Stress Disorder (ASD). The Phase 2 PREVAIL trial in fibromyalgia-type Long COVID showed improvements in fatigue, sleep, and cognitive function but did not meet the primary endpoint of pain reduction. TNX-102 SL was well-tolerated with no new safety signals. The OASIS trial will start enrolling patients in Q2 2024 to evaluate TNX-102 SL's efficacy in reducing ASD and PTSD symptoms post-trauma. Tonix plans to submit an NDA for TNX-102 SL for fibromyalgia management in H2 2024.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced two oral and one poster presentation at the American Transplant Congress 2024, showcasing research on TNX-1500, a humanized monoclonal antibody targeting CD40-ligand for organ transplant rejection. These presentations, led by researchers from Massachusetts General Hospital, will cover novel approaches and protocols in immunosuppression and immune tolerance. The presentations are scheduled for June 3-4, 2024, at the Pennsylvania Convention Center. Tonix aims to submit a New Drug Application for Tonmya for fibromyalgia in H2 2024 and is also developing treatments for CNS disorders, autoimmunity, and rare diseases.
Tonix Pharmaceuticals announced that Chief Operating Officer Jessica Morris will present at the 2024 BIO International Convention in San Diego on June 4, 2024. The presentation will discuss statistically significant Phase 3 results of Tonmya™ for fibromyalgia management, with a New Drug Application (NDA) to the FDA planned for the second half of 2024. Tonix focuses on central nervous system (CNS) disorders, including treatments for acute stress reaction and Long COVID. The company's immunology portfolio targets organ transplant rejection and autoimmune diseases. Tonix markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment.
Tonix Pharmaceuticals will deliver an oral presentation and present two posters at the ASCP Annual Meeting from May 28-31, 2024. The oral presentation will cover findings from Phase 3 studies of Tonmya (TNX-102 SL) for fibromyalgia, which met its primary endpoint, reducing daily pain significantly compared to a placebo. Posters will highlight TNX-102 SL's Phase 2 study in Long COVID and an upcoming trial on acute stress disorder. Tonix plans to submit an NDA to the FDA in the second half of 2024 for Tonmya. The presentations will be available on Tonix's website after the conference.
Tonix Pharmaceuticals has announced key findings from the initial phase of EVERSANA's market analysis for Tonmya, a potential first-line, non-opioid treatment for fibromyalgia. The report reveals high interest in Tonmya among primary care physicians and significant dissatisfaction with current FDA-approved drugs. Opioids are frequently prescribed despite their risks. Tonmya has shown promising results in two Phase 3 trials, reducing pain and improving sleep and overall symptoms. Tonix aims to submit an NDA to the FDA in the second half of 2024, with an anticipated launch in 2025.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman will participate virtually in a fireside chat at the A.G.P. Healthcare Company Showcase on May 21, 2024, at 9:00 a.m. ET.
The presentation will be live webcast and available for replay on the Tonix website.
Tonix is a biopharmaceutical company focused on developing therapeutics for CNS disorders, including submitting a New Drug Application (NDA) for Tonmya in the second half of 2024.
Other key products in their portfolio include TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection and autoimmune diseases. Tonix also markets Zembrace SymTouch and Tosymra for acute migraine treatment.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced its Q1 2024 financial results and operational highlights. The company is preparing to submit a New Drug Application (NDA) for Tonmya™ for fibromyalgia by H2 2024, with FDA approval expected in H2 2025. Tonmya, a non-opioid analgesic, has shown efficacy in Phase 3 trials without common side effects. Net revenue for Q1 2024 was $2.5 million, with a net loss of $14.9 million. Other key programs include treatments for PTSD, Long COVID, cocaine intoxication, and rare diseases. Cash and equivalents were $7.0 million as of March 31, 2024.
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