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 (TNXP) is a clinical-stage biopharmaceutical company developing innovative therapeutics for central nervous system disorders, immunology, and infectious diseases. This page provides timely updates on TNXP's clinical trials, regulatory milestones, and strategic initiatives.
Key resources for investors include press releases covering product development progress, partnership announcements, and financial reports. Our curated news collection helps track TNXP's pipeline candidates like TNX-102 SL for fibromyalgia and Tonmya™ for PTSD management.
Stay informed about developments in migraine therapeutics, rare disease research, and vaccine programs. Content categories include FDA communications, clinical trial results, intellectual property updates, and market expansion activities.
Bookmark this page for direct access to verified TNXP updates. Check regularly for new developments in biopharmaceutical innovation impacting patient care and treatment paradigms.
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 (NASDAQ:TNXP) is advancing TNX-102 SL, a non-opioid treatment for fibromyalgia, with potential FDA approval by August 15, 2025. The sublingual medication, taken at bedtime, targets sleep disturbance in fibromyalgia patients, addressing a critical market need where 85% of patients fail first-line therapy.
The chronic pain drug market, including fibromyalgia, is projected to grow from $72.10 billion in 2024 to $115.51 billion by 2031. TNX-102 SL could serve both traditional fibromyalgia patients and Long COVID sufferers, as fibromyalgia has been recognized as a diagnosable condition in Long COVID by the National Academies of Science, Engineering and Medicine. According to recent data, approximately 17.8 million U.S. adults have long COVID.
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 (NASDAQ:TNXP) is developing TNX-801, a single-dose vaccine candidate for mpox, as global cases of the new Clade I strain continue to spread. The current outbreak has caused over 45,000 cases and 1,400 deaths since 2022, with a 3% mortality rate primarily in African countries.
Unlike the 2022 Clade II outbreak that mainly affected gay men, the new Clade I variant spreads within families and particularly affects children, who are more susceptible to severe disease. TNX-801, based on synthesized horsepox, has shown promising results in animal studies, providing single-dose protection against Clade I mpox with better tolerability than traditional vaccinia vaccines.
Current vaccines have limitations: Jynneos requires two doses and is only 66% effective with full dosing, while ACAM2000 has significant side effects. TNX-801 aligns with WHO requirements for an ideal mpox vaccine, offering potential single-dose protection, conventional manufacturing processes, and the ability to limit forward transmission.
