Welcome to our dedicated page for Tonix Pharmaceuticals Holding news (Ticker: TNXP), a resource for investors and traders seeking the latest updates and insights on Tonix Pharmaceuticals Holding stock.
Tonix Pharmaceuticals Holding Corp. develops and commercializes biotechnology products for central nervous system disorders, immunology, infectious diseases and rare diseases. Company news centers on TONMYA, an FDA-approved cyclobenzaprine HCl sublingual tablet for fibromyalgia in adults, along with marketed acute migraine products Zembrace SymTouch and Tosymra.
Recurring updates also cover Tonix’s development pipeline, including TNX-4800, a long-acting anti-Borrelia OspA human monoclonal antibody for Lyme disease prophylaxis; TNX-1900 intranasal potentiated oxytocin for craniofacial pain conditions; TNX-1700 and TNX-4700 immuno-oncology programs; TNX-801 vaccine research; and TNX-1500 for prevention of kidney transplant rejection. Other company developments include scientific presentations, clinical and preclinical data, commercial access arrangements, operating results, capital-structure disclosures and governance matters.
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.
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.