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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 promising Phase 3 results for Tonmya™ (TNX-102 SL) at the EULAR 2024 Congress, showing significant pain reduction and broad symptom improvement for fibromyalgia patients. The RESILIENT study, the second Phase 3 trial, met the primary pain endpoint and all six key secondary endpoints, including sleep quality, fatigue, and overall fibromyalgia symptoms. Tonmya was well tolerated with no new safety signals. An NDA submission to the FDA is planned for the second half of 2024.
Tonix Pharmaceuticals announced the closing of its $4.0 million public offering on June 13, 2024. The offering included 1,199,448 shares of common stock and pre-funded warrants for up to 2,568,110 shares at $1.065 per share and $1.064 per warrant, respectively.
The gross proceeds, totaling $4.0 million, will be used for working capital, general corporate purposes, and preparing a new drug application for Tonmya™, aimed at treating fibromyalgia. Dawson James Securities acted as the sole placement agent. The offering was conducted under an effective shelf registration statement filed with the SEC.
Tonix Pharmaceuticals announced the pricing of a $4.0 million public offering. The offering includes 3,753,558 shares of common stock or pre-funded warrants at $1.065 per share. Gross proceeds will be approximately $4.0 million, with net proceeds used for working capital, corporate purposes, and preparing a new drug application for its Tonmya™ product. Closing is expected around June 13, 2024. Dawson James Securities will act as the sole placement agent. The offering is under an effective shelf registration statement filed with the SEC.
Tonix Pharmaceuticals announced a proposed public offering to sell shares of its common stock or pre-funded warrants, facilitated by Dawson James Securities. The offering is contingent on market conditions, and its completion date and size remain uncertain. The proceeds will support working capital, corporate purposes, including a new drug application for Tonmya™ for fibromyalgia, and debt reduction. The offering is made under an effective shelf registration statement filed with the SEC. Tonix focuses on therapeutics for CNS disorders, including fibromyalgia and Long COVID, and has several drugs in development, such as TNX-1300 and TNX-1500.
Tonix Pharmaceuticals announced a 1-for-32 reverse stock split, effective June 10, 2024. This move aims to increase the stock price to meet NASDAQ's $1.00 minimum bid requirement. Each 32 pre-split shares will convert to one post-split share, impacting outstanding common stock, warrants, and stock options. The company's stock will continue trading under the symbol 'TNXP' with a new CUSIP number, 890260847. Shareholders approved this action on May 22, 2024. Fractional shares will be rounded up, and VStock Transfer will manage the exchange process. No cash will be given for fractional shares.
Tonix Pharmaceuticals announced its participation at the American Transplant Congress 2024, revealing promising data for their drug TNX-1500.
The company shared two oral presentations and one poster presentation. The key highlights include the potential of TNX-1500 as a monotherapy or in combination to prevent organ rejection in allograft and xenograft animal models, promising outcomes in nonhuman primate and gene-edited pig heart models, and the expansion of immune tolerance protocols.
Tonix also completed a Phase 1 study of TNX-1500, assessing its safety and pharmacokinetics, and plans to move to Phase 2 trials in kidney transplant recipients.
Tonix Pharmaceuticals announced a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2024 in Vienna, Austria, from June 12-15, 2024. The presentation will showcase statistically significant Phase 3 results of Tonmya™ (TNX-102 SL) for fibromyalgia management. Tonix plans to submit a New Drug Application (NDA) to the FDA in the second half of 2024. The company's portfolio focuses on CNS disorders, with products like 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 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.