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 (TNXP) has partnered with Kenya Medical Research Institute (KEMRI) to develop a Phase I clinical study for TNX-801, a vaccine candidate for mpox prevention. The study will evaluate the safety, tolerability, and immunogenicity of TNX-801 in Kenya. The vaccine, which showed promising preclinical results, aligns with WHO's preferred target product profile for mpox vaccines, featuring single-dose administration and ambient temperature stability. This development comes as WHO declared mpox a public health emergency, with new Clade Ib cases detected across multiple countries. Tonix also announced a collaboration with Bilthoven Biologics for GMP manufacturing processes.
Tonix Pharmaceuticals presented data on their potential mpox vaccine TNX-801 at the World Vaccine Congress-Europe 2024. The preclinical data showed positive efficacy and tolerability in immunocompromised animals, with no evidence of spreading to blood or tissues even at doses 100-fold higher than traditional vaccinia vaccines. TNX-801, a single-dose attenuated live-virus vaccine, demonstrated protection against lethal clade I monkeypox challenge, preventing clinical disease and lesions while decreasing viral shedding. The vaccine aligns with WHO's preferred target product profile criteria and shows promise in addressing the recent clade I mpox outbreak declared as a Public Health Emergency of International Concern.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman will present at BIO-Europe® 2024 on November 4, 2024, at 1:00 p.m. CET in Stockholm, Sweden. The company is developing several key products, including TNX-102 SL for fibromyalgia, which has received FDA Fast Track designation. Their portfolio includes TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection. Notably, Tonix recently secured a contract worth up to $34 million with the U.S. DoD's DTRA to develop TNX-4200, an antiviral agent. The company also markets migraine treatments Zembrace® SymTouch® and Tosymra® through its commercial subsidiary.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that Chief Operating Officer Jessica Morris will present at the ThinkEquity Conference on October 30, 2024, at 9:30 a.m. ET at the Mandarin Oriental, New York. The company is a fully-integrated biopharmaceutical firm focusing on pain management and public health solutions. Their key development includes TNX-102 SL for fibromyalgia, which has received FDA Fast Track designation. The company recently secured a contract with the U.S. DoD's DTRA worth up to $34 million for developing TNX-4200. Their commercial subsidiary, Tonix Medicines, markets Zembrace SymTouch and Tosymra for acute migraine treatment.
Tonix Pharmaceuticals (Nasdaq: TNXP) has received its first payment from the Defense Threat Reduction Agency (DTRA) under a contract worth up to $34 million over five years. The funding aims to develop broad-spectrum antiviral agents for protecting military personnel in biological threat environments. This non-dilutive funding supports Tonix's ongoing research to advance its antiviral discovery program.
The contract will accelerate the development of Tonix's broad-spectrum antiviral program, focusing on phosphatase inhibitors targeting CD45. The company plans to optimize lead compounds for therapeutic intervention against biothreat agents. Tonix will utilize its research facilities, including a Biosafety Level 3 (BSL-3) lab at its research and development center in Frederick, Md., to carry out this work.
Tonix Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for TNX-102 SL, a non-opioid, centrally-acting analgesic for fibromyalgia. The NDA is based on two successful Phase 3 studies showing statistically significant pain reduction. TNX-102 SL has been granted Fast Track designation by the FDA, potentially expediting the review process.
Key points:
- TNX-102 SL could be the first new drug for fibromyalgia in over 15 years
- It targets non-restorative sleep characteristic of fibromyalgia
- The drug was generally well-tolerated in clinical trials
- Fibromyalgia affects more than 10 million adults in the U.S., mostly women
- If approved, TNX-102 SL would be the first in a new class of analgesic drugs for fibromyalgia
The company expects an FDA decision on approval in 2025, pending acceptance of the NDA for review.
Tonix Pharmaceuticals (Nasdaq: TNXP) has announced an AI and ML research collaboration with X-Chem to accelerate the development of oral broad-spectrum antivirals. The collaboration focuses on Tonix's TNX-4200 antiviral program, which aims to develop oral CD45 phosphatase inhibitors with broad-spectrum activity against various viral families.
Tonix has been awarded a contract with the U.S. Department of Defense's Defense Threat Reduction Agency (DTRA) for up to $34 million to advance the TNX-4200 program, including an IND submission and a Phase 1 clinical study. The collaboration with X-Chem is expected to optimize the physicochemical properties, pharmacokinetics, and safety attributes of Tonix's drug candidates.
Tonix plans to leverage its research facilities, including a BSL-3 lab and an ABSL-3 facility at its research and development center in Frederick, Md., to support the development of these host-directed broad-spectrum antiviral programs.
Tonix Pharmaceuticals (NASDAQ:TNXP) is developing TNX-102 SL, a non-opioid drug for fibromyalgia, addressing the urgent need for safer pain management options amid the opioid crisis. The company plans to submit a New Drug Application (NDA) in October 2024, with potential for Priority Review. TNX-102 SL targets disturbed sleep in fibromyalgia patients, offering a novel approach to pain management without addiction risks.
Simultaneously, Vertex Pharmaceuticals has filed an NDA for VX-458, a non-opioid acute pain treatment granted Priority Review by the FDA. These developments reflect a broader industry shift towards non-addictive painkillers, supported by government initiatives like the HEAL Initiative. With an estimated 100 million Americans affected by chronic pain, including 10 million with fibromyalgia, these new treatments could significantly impact pain management practices and help combat the opioid epidemic.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced its participation in the 'Endpoints' panel at the RECOVER Treating Long COVID (TLC) workshop hosted by the Foundation for the National Institutes of Health (FNIH) and National Institute of Allergy and Infectious Diseases (NIAID). CEO Dr. Seth Lederman shared insights from developing TNX-102 SL for fibromyalgia and Long COVID.
Dr. Lederman recommended validating Patient Global Impression of Change (PGIC) as a primary endpoint for Long COVID therapeutic trials, drawing parallels to the successful use of Progression-Free Survival in cancer drug development. Tonix expects to submit a New Drug Application (NDA) for TNX-102 SL in fibromyalgia to the FDA in October.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced the issuance of U.S. Patent No. 12,097,183, covering the subcutaneous delivery of Zembrace® SymTouch® (sumatriptan succinate injection) for migraine treatment. The patent, expected to provide market exclusivity until 2036, claims the use of a pre-filled autoinjector for treating migraines via subcutaneous administration.
Tonix recently launched an educational campaign, "Does Your Migraine Pill Work Every Time?" to promote non-oral migraine medications. The company is also launching a new website, www.gpmigraine.com, to educate patients about gastroparesis and migraine, emphasizing how non-oral medicines can help manage migraines more effectively.