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) presented promising data for its TNX-801 mpox vaccine candidate at the World Vaccine Congress Washington 2025. The single-dose, live virus vaccine demonstrated protective immunity against mpox and smallpox in preclinical studies.
Key findings show that TNX-801:
- Protected immunocompromised animals from lethal clade IIa monkeypox virus challenge
- Provided six-month protection against lethal rabbitpox challenge
- Showed good tolerability in immunocompromised animals with no spreading to blood or tissues
- Prevented both clinical disease and lesion formation after single-dose vaccination
The vaccine development addresses ongoing concerns about mpox epidemics, with both clade IIb (2022) and clade Ib (2024) outbreaks being declared WHO Public Health Emergencies. TNX-801 aligns with WHO's preferred target product profile, featuring single-dose administration, durable protection, and ambient temperature stability.
Tonix Pharmaceuticals (TNXP) has announced its participation in the World Vaccine Congress Washington 2025, scheduled for April 22-24, 2025. The company will deliver an oral presentation on their novel single-dose mpox vaccine and lead a panel discussion on mpox and smallpox threats.
Key developments include their TNX-102 SL candidate for fibromyalgia, which has a PDUFA date of August 15, 2025, and has received Fast Track designation. The company also has TNX-1300 for cocaine intoxication in Phase 2 with Breakthrough Therapy designation, and TNX-4200, supported by a DoD contract worth up to $34 million.
Tonix's commercial subsidiary markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment. The company maintains a research facility in Frederick, Md., focusing on infectious disease research.
Tonix Pharmaceuticals (NASDAQ: TNXP) and Makana Therapeutics have announced a collaborative research agreement to study Tonix's anti-CD40L monoclonal antibody candidate, TNX-1500, in combination with Makana's genetically engineered organs for treating organ failure.
The collaboration will focus on preclinical studies across multiple Makana programs including kidney, heart, and islet cell transplant. The research aims to support an IND submission to the FDA for compassionate use in xenotransplantation patients.
Makana's genetically engineered pigs, featuring deleted swine leukocyte antigen (SLA)2, have demonstrated improved human compatibility and advantages in fertility and birthing rates. TNX-1500 has shown best-in-class results in preventing rejection in 6-month studies of allo- and xenotransplantation in animals, as well as promising pharmacokinetics and pharmacodynamics in human studies.
Tonix Pharmaceuticals (TNXP) presented data at the AAPM 2025 Annual Meeting regarding TNX-102 SL, their sublingual cyclobenzaprine formulation for fibromyalgia treatment. The drug demonstrated statistically significant improvement in reducing fibromyalgia pain in two pivotal Phase 3 studies.
The FDA has set a PDUFA date of August 15, 2025 for TNX-102 SL. If approved, it would become the first new drug for fibromyalgia treatment in over 15 years and the first in a new class of non-opioid analgesics.
The drug, designed as a bedtime treatment targeting non-restorative sleep, works as a potent antagonist at four post-synaptic receptors. Its transmucosal delivery system bypasses first-pass hepatic metabolism, resulting in greater bioavailability of cyclobenzaprine aligned with the sleep cycle.
Tonix Pharmaceuticals (NASDAQ: TNXP) has announced that CEO Seth Lederman will present at the 2025 Jones Trading Healthcare and Innovation Conference on April 9, 2025, at 10:00 a.m. PT in Las Vegas.
The company's key developments include:
- TNX-102 SL for fibromyalgia management with a PDUFA date of August 15, 2025, and Fast Track designation
- TNX-1300, a Phase 2 biologic with Breakthrough Therapy designation for cocaine intoxication
- TNX-1500 for organ transplant rejection and autoimmune diseases
- TNX-801, a vaccine candidate for mpox
- A new $34 million DoD contract for developing TNX-4200 antiviral agents
Tonix Medicines currently markets Zembrace SymTouch and Tosymra for acute migraine treatment in adults.
Tonix Pharmaceuticals (TNXP) has launched TONIX ONE™, a comprehensive digital platform for migraine management. The platform integrates partnerships with UpScript Telemedicine, ProModRx, Blink Health, and a leading migraine diary app to streamline patient care from symptom tracking to prescription fulfillment.
The platform offers educational resources about migraines, connects patients with specialists via telehealth, and facilitates e-prescription requests. Through the integrated mobile application, patients can track symptoms and gather data-driven insights to optimize their treatment.
Additionally, Tonix provided updates on its development portfolio, including TNX-102 SL for fibromyalgia with a PDUFA date of August 15, 2025, and various other candidates in development such as TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection. The company also highlighted a recent DoD contract worth up to $34 million for developing TNX-4200.
Tonix Pharmaceuticals (TNXP) announced a presentation at the AAPM 2025 Annual Meeting in Austin, Texas. The company's CEO will present a poster on April 5, 2025.
Key highlights include the pending FDA decision for TNX-102 SL for fibromyalgia management, with a PDUFA date of August 15, 2025. The drug received Fast Track designation and is supported by two statistically significant Phase 3 studies.
The company's pipeline includes TNX-1300 for cocaine intoxication (Phase 2, Breakthrough Therapy designation), TNX-1500 for organ transplant rejection, and TNX-801 for mpox. Notably, Tonix secured a DoD contract worth up to $34 million for developing TNX-4200, targeting CD45.
Through Tonix Medicines, the company markets Zembrace SymTouch and Tosymra for acute migraine treatment in adults.
Tonix Pharmaceuticals (TNXP) announced that the FDA will not require an Advisory Committee meeting for its New Drug Application (NDA) for TNX-102 SL, a non-opioid analgesic for fibromyalgia management. The company maintains its PDUFA goal date of August 15, 2025, with potential commercial launch in Q4 2025.
If approved, TNX-102 SL (cyclobenzaprine HCl sublingual tablets) would represent the first new fibromyalgia treatment in over 15 years. The drug received Fast Track designation from the FDA in 2024, highlighting its potential to address an unmet medical need in treating fibromyalgia, which affects more than 10 million adults in the U.S.
Tonix Pharmaceuticals (TNXP) reported its Q4 and full year 2024 financial results, highlighting key developments. The company's lead candidate TNX-102 SL for fibromyalgia has an FDA PDUFA date of August 15, 2025, potentially becoming the first new fibromyalgia treatment in over 15 years.
With $98.8 million in cash as of December 31, 2024, Tonix expects sufficient funding through the PDUFA date and anticipated Q4 2025 product launch. The company reported positive Phase 1 results for TNX-1500, their next-generation anti-CD40L mAb for kidney transplant rejection prevention.
Additional highlights include receiving a government grant for TNX-801, a potential mpox vaccine, and initial payments from a DoD contract worth up to $34 million over five years for developing broad-spectrum antivirals. The company remains debt-free and is actively expanding its commercial team in preparation for TNX-102 SL's potential launch.
Tonix Pharmaceuticals (TNXP) announced its upcoming presentation at the BIO-Europe Spring 2025 Convention in Milan, Italy. CEO Seth Lederman will present on March 17, 2025, focusing on TNX-102 SL for fibromyalgia management.
Key highlights include the FDA's PDUFA goal date of August 15, 2025 for TNX-102 SL marketing authorization decision, potentially becoming the first new fibromyalgia treatment in 15 years. The FDA has granted Fast Track designation to this candidate.
The company recently secured a contract worth up to $34 million with the U.S. DoD's Defense Threat Reduction Agency to develop TNX-4200. Their pipeline includes TNX-1300 for cocaine intoxication with FDA Breakthrough Therapy designation, and TNX-1500 for organ transplant rejection and autoimmune diseases.