Tonix Pharmaceuticals Announces Poster Presentation at the American College of Rheumatology (ACR) Convergence 2024 Annual Meeting
Tonix Pharmaceuticals (TNXP) announced a poster presentation at the ACR Convergence 2024 Annual Meeting in Washington, D.C. CEO Seth Lederman will present data on a Phase 3 trial of TNX-102 SL for fibromyalgia. The company awaits FDA decision on NDA acceptance and PDUFA date in December, with potential approval decision in 2025. The FDA has granted Fast Track designation for TNX-102 SL. The company's pipeline includes TNX-1300 for cocaine intoxication, TNX-1500 for organ transplant rejection, and recently secured a DoD contract worth up to $34 million for developing TNX-4200 antiviral agents.
Tonix Pharmaceuticals (TNXP) ha annunciato una presentazione di poster al Meeting Annuale ACR Convergence 2024 a Washington, D.C. Il CEO Seth Lederman presenterà i dati di uno studio di Fase 3 su TNX-102 SL per la fibromialgia. L'azienda attende la decisione della FDA sull'accettazione della NDA e sulla data PDUFA a dicembre, con una potenziale decisione di approvazione nel 2025. La FDA ha concesso la designazione Fast Track per TNX-102 SL. Il portafoglio dell'azienda include TNX-1300 per intossicazione da cocaina, TNX-1500 per il rigetto di trapianti d'organo, e ha recentemente ottenuto un contratto con il DoD del valore di fino a 34 milioni di dollari per lo sviluppo di agenti antivirali TNX-4200.
Tonix Pharmaceuticals (TNXP) anunció una presentación de póster en la Reunión Anual ACR Convergence 2024 en Washington, D.C. El CEO Seth Lederman presentará datos de un ensayo de Fase 3 de TNX-102 SL para la fibromialgia. La compañía espera la decisión de la FDA sobre la aceptación de la NDA y la fecha PDUFA en diciembre, con una posible decisión de aprobación en 2025. La FDA ha otorgado la designación de Fast Track para TNX-102 SL. El pipeline de la empresa incluye TNX-1300 para la intoxicación por cocaína, TNX-1500 para el rechazo de órganos trasplantados, y recientemente aseguró un contrato con el DoD por un valor de hasta 34 millones de dólares para desarrollar agentes antivirales TNX-4200.
Tonix Pharmaceuticals (TNXP)는 워싱턴 D.C.에서 열리는 ACR Convergence 2024 연례 회의에서 포스터 발표를 알렸습니다. CEO Seth Lederman은 섬유근육통 치료를 위한 TNX-102 SL의 3상 시험 데이터에 대해 발표할 예정입니다. 회사는 12월에 NDA 수용 여부 및 PDUFA 날짜에 대한 FDA의 결정을 기다리고 있으며, 2025년에 승인을 받을 가능성이 있습니다. FDA는 TNX-102 SL에 대해 패스트 트랙 지정을 부여했습니다. 이 회사의 파이프라인에는 코카인 중독을 위한 TNX-1300, 장기 이식을 위한 TNX-1500, 그리고 최근에는 TNX-4200 항바이러스제를 개발하기 위해 최대 3,400만 달러 규모의 DoD 계약을 확보했습니다.
Tonix Pharmaceuticals (TNXP) a annoncé une présentation d'affiche lors de la Réunion Annuelle ACR Convergence 2024 à Washington, D.C. Le PDG Seth Lederman présentera des données sur un essai de Phase 3 de TNX-102 SL pour la fibromyalgie. L'entreprise attend une décision de la FDA concernant l'acceptation de la NDA et la date PDUFA en décembre, avec une décision d'approbation potentielle en 2025. La FDA a accordé le statut Fast Track à TNX-102 SL. Le pipeline de l'entreprise comprend TNX-1300 pour l'intoxication à la cocaïne, TNX-1500 pour le rejet de greffe d'organe, et a récemment obtenu un contrat avec le DoD d'une valeur allant jusqu'à 34 millions de dollars pour le développement d'agents antiviraux TNX-4200.
Tonix Pharmaceuticals (TNXP) kündigte eine Posterpräsentation auf dem ACR Convergence 2024 Jahrestreffen in Washington, D.C. an. CEO Seth Lederman wird Daten zu einer Phase-3-Studie von TNX-102 SL bei Fibromyalgie präsentieren. Das Unternehmen wartet auf die Entscheidung der FDA über die Annahme des NDA und das PDUFA-Datum im Dezember, mit möglicher Genehmigungsentscheidung im Jahr 2025. Die FDA hat TNX-102 SL den Fast-Track-Status gewährt. Die Pipeline des Unternehmens umfasst TNX-1300 für Kokainintoxikation, TNX-1500 zur Abstoßung von Organtransplantaten und hat kürzlich einen DoD-Vertrag in Höhe von bis zu 34 Millionen US-Dollar zur Entwicklung von TNX-4200 antiviralen Mitteln gesichert.
- FDA Fast Track designation received for TNX-102 SL for fibromyalgia management
- Secured DoD contract worth up to $34 million for TNX-4200 development
- Two statistically significant Phase 3 studies completed for fibromyalgia treatment
- NDA submitted for TNX-102 SL with FDA decision expected in December
- FDA approval for TNX-102 SL still pending and not guaranteed
- Multiple product candidates still in early development phases
CHATHAM, N.J., Nov. 13, 2024 (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 Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will deliver a poster presentation at the ACR Convergence 2024 Annual Meeting, which will be held in Washington, D.C., November 14-19, 2024. 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 ACR website here.
Presentation Details
| Presenter: | Seth Lederman, M.D. |
| Title: | Randomized, Double-Blind, Placebo-Controlled Confirmatory Phase 3 Trial of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Fibromyalgia |
| Poster No.: | 1218 |
| Session: | Poster Session B, Pain in Rheumatic Disease Including Fibromyalgia Poster |
| Location: | Walter E. Washington Convention Center, Washington, D.C. |
| Date: | Sunday, November 17, 2024 |
| Time: | 10:30 a.m. – 12:30 p.m. ET |
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. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. We expect an FDA decision on the acceptance of the NDA for review and a PDUFA date in December and if accepted, a decision on NDA approval in 2025. 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 U.S. National Institute of Drug Abuse and Addiction. 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 also has product candidates in development in the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced 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 Toni’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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Toni’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) 904-8182
Peter Vozzo
ICR Healthcare
peter.vozzo@westwicke.com
(443) 213-0505
Media Contact
Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432
FAQ
When will the FDA decide on Tonix's (TNXP) TNX-102 SL NDA acceptance?
What is the value of Tonix Pharmaceuticals' (TNXP) DoD contract for TNX-4200?
What is the status of Tonix's (TNXP) TNX-102 SL for fibromyalgia?
