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Tonix Pharmaceuticals Announces Presentation at Planet MicroCap Showcase

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Tonix Pharmaceuticals Holding Corp. announced that Dr. Seth Lederman will present at the Planet MicroCap Showcase to discuss positive Phase 3 trial data of Tonmya for fibromyalgia management. The company focuses on CNS disorders and plans to submit an NDA for Tonmya in 2024. Tonix also works on biologics for organ transplant rejection, autoimmune diseases, cancer, and rare/infectious diseases.
Tonix Pharmaceuticals Holding Corp. ha annunciato che il Dr. Seth Lederman presenterà allo Showcase di Planet MicroCap per discutere i dati positivi della Fase 3 dello studio su Tonmya per la gestione della fibromialgia. L'azienda è concentrata sui disturbi del sistema nervoso centrale e prevede di presentare una NDA per Tonmya nel 2024. Tonix lavora anche su biologici per il rigetto di trapianti d'organo, malattie autoimmuni, cancro e malattie rare/infettive.
Tonix Pharmaceuticals Holding Corp. anunció que el Dr. Seth Lederman presentará en el Planet MicroCap Showcase para discutir los datos positivos de la Fase 3 del ensayo de Tonmya para el manejo de la fibromialgia. La compañía se enfoca en trastornos del sistema nervioso central y planea presentar una NDA para Tonmya en 2024. Tonix también trabaja en biológicos para el rechazo de trasplantes de órganos, enfermedades autoinmunes, cáncer y enfermedades raras/infecciosas.
토닉스 파마수티컬스 홀딩스 코프는 세스 레더맨 박사가 플래닛 마이크로캡 쇼케이스에서 발표를 하여 통마야의 섬유근육통 관리를 위한 3상 시험의 긍정적 데이터를 논의할 것이라고 발표했습니다. 이 회사는 중추신경계 장애에 집중하고 있으며 2024년에 통마야에 대한 NDA를 제출할 계획입니다. 토닉스는 또한 장기 이식 거부, 자가면역 질환, 암 및 희귀/감염성 질환을 위한 생물학적 제품에도 작업하고 있습니다.
Tonix Pharmaceuticals Holding Corp. a annoncé que le Dr. Seth Lederman présentera lors du Planet MicroCap Showcase pour discuter des données positives de l'essai de phase 3 de Tonmya pour la gestion de la fibromyalgie. L'entreprise se concentre sur les troubles du système nerveux central et prévoit de soumettre une demande de NDA pour Tonmya en 2024. Tonix travaille également sur des produits biologiques pour le rejet de transplantation d'organes, les maladies auto-immunes, le cancer, et les maladies rares/infectieuses.
Tonix Pharmaceuticals Holding Corp. hat angekündigt, dass Dr. Seth Lederman auf dem Planet MicroCap Showcase präsentieren wird, um über positive Phase-3-Studiendaten von Tonmya zur Behandlung von Fibromyalgie zu diskutieren. Das Unternehmen konzentriert sich auf ZNS-Erkrankungen und plant, 2024 eine NDA für Tonmya einzureichen. Tonix arbeitet auch an Biologika gegen Abstoßung von Organtransplantaten, Autoimmunerkrankungen, Krebs und seltene/infektiöse Krankheiten.
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CHATHAM, N.J., April 24, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer, will present at the Planet MicroCap Showcase in Las Vegas, Nev. on May 1, 2024, at 8:00 a.m. PT (11:00 a.m. ET). The presentation will include data from the recently reported positive Phase 3 RESILIENT trial of Tonmya™ (also known as TNX-102 SL) for the management of fibromyalgia.

The presentation will be webcast here. A copy of the Company’s presentation will be available under the Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the showcase website.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a 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 and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has 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, 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 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) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151


FAQ

What did Tonix Pharmaceuticals announce?

Tonix Pharmaceuticals announced that Dr. Seth Lederman will present at the Planet MicroCap Showcase to discuss positive Phase 3 trial data of Tonmya (TNX-102 SL) for fibromyalgia management.

When will the presentation take place?

The presentation will take place on May 1, 2024, at 8:00 a.m. PT (11:00 a.m. ET) in Las Vegas, Nev.

What is the focus of Tonix Pharmaceuticals' development portfolio?

Tonix Pharmaceuticals focuses on developing therapeutics for central nervous system (CNS) disorders, including products for fibromyalgia, acute stress reaction, Long COVID, and cocaine intoxication.

What is the status of Tonix's product candidate Tonmya?

Tonmya is awaiting an NDA submission to the FDA in the second half of 2024 for the management of fibromyalgia, following two statistically significant Phase 3 studies.

What other areas does Tonix Pharmaceuticals work on?

Tonix Pharmaceuticals also works on biologics for organ transplant rejection, autoimmune diseases, cancer, rare diseases, and infectious diseases.

Tonix Pharmaceuticals Holding Corp.

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About TNXP

tonix is developing innovative pharmaceutical products to address major public health challenges. in addition to tonmya for ptsd, tonix is developing tnx-601 (tianeptine oxalate), a clinical candidate at pre-ind (investigational new drug) application stage, designed as a daytime treatment for ptsd and tnx-801, a live synthetic version of horsepox virus, at the pre-ind application stage, to be developed as a potential smallpox-preventing vaccine. further information about tonix can be found at www.tonixpharma.com.