Welcome to our dedicated page for Tonix Pharmaceut news (Ticker: TNXP), a resource for investors and traders seeking the latest updates and insights on Tonix Pharmaceut stock.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) generates a steady flow of news as a fully integrated, commercial-stage biotechnology company with both marketed products and a broad development pipeline. News coverage for Tonix often centers on its FDA-approved fibromyalgia treatment TONMYA, its acute migraine products Zembrace SymTouch and Tosymra, and updates on clinical and regulatory milestones across central nervous system, immunology, rare disease and infectious disease programs.
Investors following TNXP news can expect announcements on commercial launches, market access decisions, and distribution arrangements for TONMYA, as well as prescription trends and formulary placements for its migraine therapies. The company also regularly reports progress on TNX-102 SL in indications such as acute stress-related conditions and major depressive disorder, including IND clearances and the design of potentially pivotal Phase 2 studies.
Tonix’s immunology and infectious disease work contributes additional news items, including collaborations with academic centers like Massachusetts General Hospital for TNX-1500 in kidney transplantation, and development plans for TNX-4800, a monoclonal antibody designed for seasonal prevention of Lyme disease. Licensing transactions, such as the acquisition of TNX-4900 for chronic neuropathic pain from Rutgers University, and government-supported projects like the DTRA-backed antiviral TNX-4200, are also common themes in company press releases.
This TNXP news page aggregates company-issued updates and related coverage so readers can quickly review developments in Tonix’s commercial operations, clinical pipeline, financing activities, and strategic collaborations. For investors and observers tracking biotech catalysts, revisiting this page provides a concise way to monitor how Tonix’s programs and capital markets actions evolve over time.
Tonix Pharmaceuticals (Nasdaq: TNXP) has regained compliance with Nasdaq's minimum bid price requirement, ensuring its continued listing on The Nasdaq Capital Market. This milestone was achieved after TNXP shares maintained a closing bid price of $1.00 or higher for at least 10 consecutive business days, as confirmed by a Nasdaq letter on June 26, 2024.
Tonix is a biopharmaceutical company specializing in CNS disorders, with a focus on developing therapeutics for conditions such as fibromyalgia and Long COVID. The company plans to submit a New Drug Application (NDA) for its fibromyalgia treatment, Tonmya, in the latter half of 2024. Tonix also aims to address cocaine intoxication, organ transplant rejection, and autoimmune diseases through its diverse development portfolio.
Tonix Pharmaceuticals presented promising data on their live virus vaccine platform at the Vaccine Congress 2024. Their TNX-801 vaccine demonstrated strong efficacy in protecting animals from lethal mpox (formerly monkeypox) challenges. TNX-801, designed for single-dose administration, offers long-term protection against mpox and smallpox. Additionally, their TNX-1800 vaccine for COVID-19 has been selected for clinical trials under NIH’s Project NextGen. The keynote highlighted the potential of these vaccines to address various infectious diseases effectively, with TNX-801 showing better tolerability compared to modern vaccines. The presentation also underscored the ongoing threat of mpox and the urgent need for advanced vaccines.
Tonix Pharmaceuticals has announced positive alignment with the FDA regarding key Chemistry, Manufacturing, and Controls (CMC) topics for their fibromyalgia treatment, Tonmya. The company, which has completed the second pre-New Drug Application (NDA) meeting, discussed nonclinical and clinical matters with the FDA, with formal minutes pending. Tonix is on track to submit the NDA for Tonmya in the second half of 2024. The FDA has agreed on commercial specifications, shelf life, manufacturing, and packaging for Tonmya. Tonix is preparing a dual manufacturing launch strategy with CDMO Almac Pharma Services and another CDMO.
Tonix Pharmaceuticals (Nasdaq: TNXP) presented a poster at the 66th Annual Scientific Meeting of the American Headache Society, highlighting a gap between the real-world use and the guidelines for non-oral migraine treatments. Their FDA-approved products, Zembrace SymTouch and Tosymra, are underutilized according to the data, with usage dropping from 7% in 2012 to below 4% in 2023. The poster stresses the need for personalized migraine treatments and the potential for increased usage of non-oral medications. Zembrace SymTouch offers rapid onset of pain relief in as few as 10 minutes and is the only actively promoted sumatriptan autoinjector in the U.S., while Tosymra provides similar benefits with a single nasal spray.
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.