Tonix Pharmaceuticals Announces Oral Presentation and Panel Participation at the World Vaccine Congress Washington 2025
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 (TNXP) ha annunciato la sua partecipazione al World Vaccine Congress Washington 2025, previsto dal 22 al 24 aprile 2025. L'azienda terrà una presentazione orale sul loro innovativo vaccino monodose contro il mpox e guiderà una tavola rotonda sulle minacce rappresentate da mpox e vaiolo.
Tra gli sviluppi principali c'è il candidato TNX-102 SL per la fibromialgia, con una data PDUFA fissata per il 15 agosto 2025 e che ha ottenuto la designazione Fast Track. L'azienda sta inoltre sviluppando TNX-1300 per l'intossicazione da cocaina, attualmente in Fase 2 con designazione Breakthrough Therapy, e TNX-4200, supportato da un contratto del Dipartimento della Difesa (DoD) del valore fino a 34 milioni di dollari.
La controllata commerciale di Tonix commercializza Zembrace® SymTouch® e Tosymra® per il trattamento dell'emicrania acuta. L'azienda dispone inoltre di un centro di ricerca a Frederick, Maryland, dedicato allo studio delle malattie infettive.
Tonix Pharmaceuticals (TNXP) ha anunciado su participación en el World Vaccine Congress Washington 2025, programado del 22 al 24 de abril de 2025. La compañía ofrecerá una presentación oral sobre su nueva vacuna de dosis única contra el mpox y liderará una mesa redonda sobre las amenazas del mpox y la viruela.
Los desarrollos clave incluyen su candidato TNX-102 SL para fibromialgia, con fecha PDUFA el 15 de agosto de 2025, que ha recibido la designación Fast Track. La empresa también cuenta con TNX-1300 para la intoxicación por cocaína en fase 2 con designación Breakthrough Therapy, y TNX-4200, respaldado por un contrato del Departamento de Defensa (DoD) por hasta 34 millones de dólares.
La subsidiaria comercial de Tonix comercializa Zembrace® SymTouch® y Tosymra® para el tratamiento de la migraña aguda. La compañía mantiene un centro de investigación en Frederick, Maryland, enfocado en enfermedades infecciosas.
Tonix Pharmaceuticals (TNXP)는 2025년 4월 22일부터 24일까지 개최되는 2025년 워싱턴 세계 백신 회의(World Vaccine Congress Washington 2025)에 참여한다고 발표했습니다. 회사는 혁신적인 단회 접종 mpox 백신에 대한 구두 발표를 진행하며, mpox 및 천연두 위협에 관한 패널 토론을 주도할 예정입니다.
주요 개발 사항으로는 섬유근육통 치료제 후보인 TNX-102 SL이 있으며, 2025년 8월 15일 PDUFA 일정이 잡혀 있고 신속 심사(Fast Track) 지정을 받았습니다. 또한 코카인 중독 치료제 TNX-1300은 혁신 치료제(Breakthrough Therapy) 지정으로 2상 임상 중이며, TNX-4200은 국방부(DoD)와 최대 3,400만 달러 규모의 계약을 체결했습니다.
Tonix의 상업 자회사는 급성 편두통 치료제 Zembrace® SymTouch®와 Tosymra®를 판매하고 있습니다. 회사는 감염병 연구에 집중하는 메릴랜드주 프레더릭에 연구 시설을 운영하고 있습니다.
Tonix Pharmaceuticals (TNXP) a annoncé sa participation au World Vaccine Congress Washington 2025, prévu du 22 au 24 avril 2025. La société donnera une présentation orale sur leur nouveau vaccin mpox à dose unique et animera une table ronde sur les menaces liées au mpox et à la variole.
Les développements clés incluent leur candidat TNX-102 SL pour la fibromyalgie, dont la date PDUFA est fixée au 15 août 2025 et qui bénéficie d'une désignation Fast Track. La société développe également TNX-1300 pour l'intoxication à la cocaïne, actuellement en phase 2 avec une désignation Breakthrough Therapy, ainsi que TNX-4200, soutenu par un contrat du DoD d'une valeur pouvant atteindre 34 millions de dollars.
La filiale commerciale de Tonix commercialise Zembrace® SymTouch® et Tosymra® pour le traitement de la migraine aiguë. La société dispose d'un centre de recherche à Frederick, Maryland, axé sur la recherche en maladies infectieuses.
Tonix Pharmaceuticals (TNXP) hat seine Teilnahme am World Vaccine Congress Washington 2025 angekündigt, der vom 22. bis 24. April 2025 stattfindet. Das Unternehmen wird einen Vortrag über seinen neuartigen Einzeldosis-Mpox-Impfstoff halten und eine Podiumsdiskussion zu den Bedrohungen durch Mpox und Pocken leiten.
Zu den wichtigsten Entwicklungen gehört der Kandidat TNX-102 SL für Fibromyalgie, mit einem PDUFA-Termin am 15. August 2025, der die Fast-Track-Zulassung erhalten hat. Das Unternehmen verfügt außerdem über TNX-1300 zur Behandlung von Kokainintoxikation in Phase 2 mit Breakthrough-Therapie-Zulassung sowie TNX-4200, das durch einen DoD-Vertrag im Wert von bis zu 34 Millionen US-Dollar unterstützt wird.
Die kommerzielle Tochtergesellschaft von Tonix vertreibt Zembrace® SymTouch® und Tosymra® zur Behandlung akuter Migräne. Das Unternehmen unterhält eine Forschungseinrichtung in Frederick, Maryland, die sich auf die Erforschung von Infektionskrankheiten spezialisiert hat.
- FDA Fast Track designation received for TNX-102 SL fibromyalgia treatment
- Up to $34 million DoD contract for TNX-4200 development
- Two marketed products generating revenue (Zembrace® SymTouch® and Tosymra®)
- PDUFA date set for TNX-102 SL, indicating advanced regulatory progress
- Multiple investigational products still requiring FDA approval
- Significant ongoing R&D expenses across multiple pipeline candidates
CHATHAM, N.J., April 16, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the Company will deliver an oral presentation and lead a panel discussion at the World Vaccine Congress Washington 2025, which will be held in Washington, D.C., April 22-24, 2025. A copy of the Company’s presentation will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the World Vaccine Congress website here.
Presentation Details
| Presenter: | Farooq Nasar, PhD, Senior Principal Investigator, Research and Development Center, Tonix Pharmaceuticals |
| Session: | Emerging & Re-emerging Diseases |
| Title: | A Novel Single-Dose, Attenuated Live, Minimally Replicative Mpox Vaccine |
| Location: | Room 202B |
| Date: | Wednesday, April 23, 2025 |
| Time: | 10:10 a.m. |
Panel Details
| Moderator: | Zeil Rosenberg, M.D., M.P.H., Executive Vice President, Medical, Tonix Pharmaceuticals |
| Session: | Emerging & Re-emerging Diseases |
| Title: | Mpox and Smallpox Threats: Vaccine Development and Biosecurity Policy |
| Location: | Room 202B |
| Date: | Wednesday, April 23, 2025 |
| Time: | 3:25 p.m. |
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599
Peter Vozzo
ICR Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505
Media Contact
Ray Jordan
Putnam Insights
(949) 245-5432
Indication and Usage
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
- discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
- history of heart problems
- narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
- uncontrolled high blood pressure
- hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
- had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
- severe liver problems
- taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
- are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
- an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
- changes in color or sensation in your fingers and toes
- sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
- cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
- increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
- medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
- serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
- hives (itchy bumps); swelling of your tongue, mouth, or throat
- seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
FAQ
When is the PDUFA date for Tonix's TNX-102 SL fibromyalgia treatment?
What is the value of TNXP's Department of Defense contract for TNX-4200?
What products does TNXP currently market for migraine treatment?
What will TNXP present at the World Vaccine Congress Washington 2025?
