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) 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.
Tonix Pharmaceuticals (NASDAQ:TNXP) has reported promising results for TNX-1500, a humanized monoclonal antibody designed to prevent organ transplant rejections and treat autoimmune diseases. The company recently announced topline results from its Phase 1 trial, demonstrating TNX-1500's ability to block immune responses in healthy volunteers with a half-life supporting monthly dosing.
TNX-1500 represents a third-generation CD40L blocker that aims to maintain the effectiveness of first-generation blockers while improving tolerability. The drug shows potential in preventing rejection of both human and pig organ transplants, addressing a critical need as over 100,000 people in the U.S. await organ transplants, with approximately 17 deaths daily due to organ shortages.
The organ transplant immunosuppressant drug market, valued at $5.5 billion in 2023, is projected to reach $7.17 billion by 2030. TNX-1500's development targets both traditional human organ transplants and xenotransplants, with potential expansion into autoimmune conditions. Animal studies have shown promising results with reduced thrombotic events, suggesting successful protein engineering modifications.
Tonix Pharmaceuticals (TNXP) has announced its upcoming presentation at the Zacks SCR Life Sciences Virtual Investor Forum on March 13, 2025, at 3:30 p.m. ET. CEO Seth Lederman will lead an interactive session where investors can engage in real-time questions.
The company's development portfolio highlights include TNX-102 SL for fibromyalgia management, with a PDUFA date of August 15, 2025. The drug has received Fast Track designation and showed positive results in two Phase 3 studies. Other key developments include TNX-1300 for cocaine intoxication treatment (Phase 2) and TNX-1500 for organ transplant rejection prevention.
Tonix's infectious disease portfolio features TNX-801 for mpox and smallpox vaccines, and TNX-4200, supported by a $34 million DoD contract. The company's commercial subsidiary, Tonix Medicines, currently markets Zembrace SymTouch and Tosymra for acute migraine treatment.
Tonix Pharmaceuticals (NASDAQ: TNXP) has received a grant from the Medical CBRN Defense Consortium (MCDC) to support the development of TNX-801, a single-dose mpox and smallpox vaccine candidate. The grant will fund comprehensive market analyses and commercialization planning for both private and government markets.
TNX-801 is an attenuated live-virus vaccine based on synthesized horsepox, demonstrating single-dose immune protection against monkeypox challenge with improved tolerability compared to traditional vaccinia vaccines in animal studies. The development comes as the WHO recently reaffirmed the spread of new clade Ib Mpox as a public health emergency (PHEIC) in February 2025, with cases detected across multiple countries in Africa, Asia, Europe, Middle East, and North America.
The vaccine candidate features potential advantages including single-dose administration for long-term protection and favorable shipping/storage requirements. TNX-801 has previously shown effectiveness in protecting animals against lethal challenge with intratracheal clade I monkeypox virus.
Tonix Pharmaceuticals (TNXP) announced that COO Jessica Morris will present at the 2025 Virtual Investor Summit on March 11, 2025, at 10:30 a.m. ET.
The company's development portfolio highlights 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
Notable developments include a $34 million DoD contract for developing TNX-4200 antiviral agents. The company operates an infectious disease research facility in Frederick, Md., and markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment through its commercial subsidiary.
Tonix Pharmaceuticals (TNXP) presented data on TNX-102 SL, their sublingual formulation of cyclobenzaprine for fibromyalgia treatment, at the 7th International Congress on Controversies in Fibromyalgia in Vienna. The drug demonstrated statistically significant improvement in reducing fibromyalgia pain in two Phase 3 studies.
TNX-102 SL has a FDA PDUFA date of August 15, 2025, and if approved, would become the first new fibromyalgia treatment in over 15 years. The drug is designed as a bedtime treatment targeting non-restorative sleep, utilizing transmucosal delivery to reduce the formation of norcyclobenzaprine.
In two 14-week Phase 3 trials, TNX-102 SL 5.6 mg met primary endpoints with significant pain reduction compared to placebo, showing good tolerability and no new safety concerns.
Tonix Pharmaceuticals (TNXP) reported preliminary 2024 financial results with $98.8 million in cash as of December 31, 2024. The company generated $10.1 million in net sales from migraine products, up from $7.8 million in 2023. Net operating loss was $126.6 million, including $59.0 million in non-cash impairment charges.
Key highlights include becoming debt-free after repaying a mortgage to JGB Capital, and raising $30.4 million through ATM facility in Q1 2025. The company expects current cash to fund operations into Q1 2026, beyond the FDA PDUFA date of August 15, 2025 for TNX-102 SL fibromyalgia treatment. Operating cash burn decreased to $60.9 million from $102.0 million in the previous year.
Tonix Pharmaceuticals (TNXP) announced positive topline results from its Phase 1 trial of TNX-1500, a next-generation anti-CD40L monoclonal antibody for kidney transplant rejection prevention and autoimmune disease treatment. The trial demonstrated that TNX-1500 effectively blocked primary and secondary antibody responses at 10 mg/kg and 30 mg/kg doses, with a mean half-life of 34-38 days supporting monthly dosing.
The drug showed a favorable safety profile and was generally well-tolerated. The only notable treatment-emergent adverse event was mild aphthous ulcer in three participants. Importantly, no thromboembolic events were reported. The study involved 26 participants across three dosing cohorts (3 mg/kg, 10 mg/kg, and 30 mg/kg), with 24 completing the trial.
Following these results, Tonix plans to discuss with the FDA in an End-of-Phase 1 meeting before proceeding with Phase 2 trials in kidney transplant recipients.
Tonix Pharmaceuticals (TNXP) has announced its participation in the BIO CEO & Investor Conference on February 10, 2025, where CEO Seth Lederman will present at 1:45 p.m. ET in New York City. The company has several key developments in progress, including:
Their priority candidate TNX-102 SL for fibromyalgia management has a PDUFA date of August 15, 2025, and has received Fast Track designation. The company recently submitted an NDA based on two successful Phase 3 studies.
Other significant developments include TNX-1300, a Phase 2 biologic with Breakthrough Therapy designation for cocaine intoxication, and a recent contract with the DoD's DTRA worth up to $34 million for developing TNX-4200. The company also markets migraine treatments Zembrace SymTouch and Tosymra through its commercial subsidiary.
