Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team with Appointment of Gary Ainsworth as Vice President of Market Access
Tonix Pharmaceuticals (TNXP) has appointed Gary Ainsworth as Vice President of Market Access, effective immediately. Ainsworth brings over two decades of industry experience, having previously served as Managing Director at Eversana Intouch and founder of Havas Gemini's Market Access Business Unit. The appointment comes as Tonix awaits FDA's decision on TNX-102 SL for fibromyalgia management, with a PDUFA date set for August 15, 2025.
The company's development portfolio focuses on CNS disorders, with TNX-102 SL as their priority candidate. The FDA previously granted Fast Track designation for this non-opioid, centrally-acting analgesic. Tonix also has other candidates in development, including TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection. The company recently secured a contract worth up to $34 million with the U.S. DoD's DTRA to develop TNX-4200.
Tonix Pharmaceuticals (TNXP) ha nominato Gary Ainsworth come Vice Presidente per l'Accesso al Mercato, con effetto immediato. Ainsworth porta con sé oltre due decenni di esperienza nel settore, avendo precedentemente ricoperto il ruolo di Direttore Generale presso Eversana Intouch e fondato l'Unità Business di Accesso al Mercato di Havas Gemini. Questa nomina arriva mentre Tonix attende la decisione della FDA su TNX-102 SL per la gestione della fibromialgia, con una data PDUFA fissata per il 15 agosto 2025.
Il portafoglio di sviluppo dell'azienda si concentra sui disturbi del SNC, con TNX-102 SL come candidato prioritario. La FDA ha precedentemente concesso la designazione Fast Track per questo analgesico non oppioide e ad azione centrale. Tonix ha anche altri candidati in sviluppo, tra cui TNX-1300 per intossicazione da cocaina e TNX-1500 per il rigetto degli organi trapiantati. L'azienda ha recentemente ottenuto un contratto del valore di fino a 34 milioni di dollari con la DTRA del Dipartimento della Difesa degli Stati Uniti per sviluppare TNX-4200.
Tonix Pharmaceuticals (TNXP) ha nombrado a Gary Ainsworth como Vicepresidente de Acceso al Mercado, con efecto inmediato. Ainsworth aporta más de dos décadas de experiencia en la industria, habiendo sido anteriormente Director General en Eversana Intouch y fundador de la Unidad de Negocios de Acceso al Mercado de Havas Gemini. El nombramiento se produce mientras Tonix espera la decisión de la FDA sobre TNX-102 SL para el manejo de la fibromialgia, con una fecha PDUFA establecida para el 15 de agosto de 2025.
El portafolio de desarrollo de la empresa se centra en los trastornos del SNC, con TNX-102 SL como su candidato prioritario. La FDA otorgó anteriormente la designación Fast Track para este analgésico no opioide y de acción central. Tonix también tiene otros candidatos en desarrollo, incluyendo TNX-1300 para la intoxicación por cocaína y TNX-1500 para el rechazo de órganos trasplantados. La empresa recientemente aseguró un contrato por un valor de hasta 34 millones de dólares con la DTRA del Departamento de Defensa de EE. UU. para desarrollar TNX-4200.
톤익스 제약 (TNXP)는 게리 에인스워스(Gary Ainsworth)를 즉시 발효되는 시장 접근 부사장으로 임명했습니다. 에인스워스는 에버사나 인투치(Eversana Intouch)에서 운영 이사로 일했으며, 하바스 제미니의 시장 접근 비즈니스 유닛을 설립한 경력을 가진 산업 경험이 20년 이상 있습니다. 이번 임명은 톤익스가 섬유근육통 관리용 TNX-102 SL에 대한 FDA의 결정을 기다리고 있는 가운데 이루어졌으며, PDUFA 날짜는 2025년 8월 15일로 설정되었습니다.
회사의 개발 포트폴리오는 중추신경계(CNS) 장애에 중점을 두고 있으며, TNX-102 SL이 주요 후보입니다. FDA는 이 비오피오이드 중앙 작용 진통제에 대해 빠른 트랙(Fast Track) 지정을 부여했습니다. 톤익스는 또한 코카인 중독을 위한 TNX-1300 및 장기 이식을 위한 TNX-1500을 포함한 여러 후보 물질을 개발 중입니다. 회사는 최근 최대 3,400만 달러 규모의 계약을 미국 국방부의 DTRA와 체결하여 TNX-4200을 개발하고 있습니다.
Tonix Pharmaceuticals (TNXP) a nommé Gary Ainsworth au poste de Vice-Président de l'Accès au Marché, avec effet immédiat. Ainsworth apporte plus de deux décennies d'expérience dans l'industrie, ayant précédemment été Directeur Général chez Eversana Intouch et fondateur de l'Unité Commerciale d'Accès au Marché de Havas Gemini. Cette nomination survient alors que Tonix attend la décision de la FDA concernant TNX-102 SL pour la gestion de la fibromyalgie, avec une Date PDUFA fixée au 15 août 2025.
Le portefeuille de développement de l'entreprise se concentre sur les troubles du SNC, avec TNX-102 SL comme candidat prioritaire. La FDA a précédemment accordé une désignation Fast Track pour cet analgésique non opioïde et à action centrale. Tonix a également d'autres candidats en développement, y compris TNX-1300 pour l'intoxication à la cocaïne et TNX-1500 pour le rejet de greffe. L'entreprise a récemment sécurisé un contrat d'une valeur allant jusqu'à 34 millions de dollars avec la DTRA du Département de la Défense des États-Unis pour développer TNX-4200.
Tonix Pharmaceuticals (TNXP) hat Gary Ainsworth sofort als Vizepräsident für Marktzugang ernannt. Ainsworth bringt über zwei Jahrzehnte Branchenerfahrung mit, nachdem er zuvor als Geschäftsführer bei Eversana Intouch und als Gründer der Marktzugangs-Geschäftseinheit von Havas Gemini tätig war. Die Ernennung erfolgt, während Tonix auf die Entscheidung der FDA zu TNX-102 SL zur Behandlung von Fibromyalgie wartete, mit einem PDUFA-Datum, das auf den 15. August 2025 festgelegt ist.
Das Entwicklungsportfolio des Unternehmens konzentriert sich auf Erkrankungen des zentralen Nervensystems, wobei TNX-102 SL den Vorrang hat. Die FDA hat zuvor eine Fast-Track-Zulassung für dieses nicht-opioide, zentral wirkende Analgetikum erteilt. Tonix hat auch andere Kandidaten in der Entwicklung, darunter TNX-1300 bei Kokainvergiftung und TNX-1500 bei Organabstoßung. Das Unternehmen hat kürzlich einen Vertrag im Wert von bis zu 34 Millionen Dollar mit dem DTRA des US-Verteidigungsministeriums gesichert, um TNX-4200 zu entwickeln.
- FDA assigned PDUFA date of August 15, 2025 for TNX-102 SL marketing authorization
- Secured $34 million contract with U.S. DoD's DTRA for TNX-4200 development
- TNX-102 SL has Fast Track designation from FDA
- Company has existing commercial products (Zembrace SymTouch and Tosymra) for migraine treatment
- TNX-102 SL and other pipeline products are still investigational with no guaranteed approval
- Multiple development programs require significant ongoing R&D expenses
Mr. Ainsworth brings over two decades of industry and market access experience to Tonix
U.S. Food and Drug Administration (FDA) recently assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for U.S. marketing authorization of TNX-102 SL for the management of fibromyalgia
CHATHAM, N.J., Jan. 08, 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 the appointment of Gary Ainsworth as Vice President, Market Access, effective immediately. Mr. Ainsworth is an accomplished executive with leadership in market access strategies from both large pharmaceutical companies and healthcare consultancies.
“Gary has a significant track record of success building market access functions, developing launch-ready access and reimbursement strategies and payer-focused resources, including those for fibromyalgia and migraine treatment options,” said Thomas Englese, EVP Commercial of Tonix Pharmaceuticals. “His extensive experience will be especially valuable as we work towards the potential approval and commercial launch of TNX-102 SL for the management of fibromyalgia this year.”
Most recently, Mr. Ainsworth was Managing Director, Head of Market Access at Eversana Intouch, where he led the agency function and the efforts to optimize the Company’s vast market access capabilities and services. Prior to that, he was the founder and Managing Director at Havas Gemini, the Market Access Business Unit of Havas Health & You that developed innovative market access strategies and solutions for their clients. Mr. Ainsworth also had a distinguished career leading pharmaceutical organizations’ market access functions. Mr. Ainsworth was the Vice President of Corporate Accounts and Customer Operations for Baxter International within the Anesthesia, Critical Care and Oncology Division where he led a team of national account managers and a patient services telemarketing center. Mr. Ainsworth also led the National Accounts and Managed Care Marketing function at Roche Laboratories and held a variety of market access leadership positions with the predecessor companies to Sanofi. Mr. Ainsworth holds a Master of Business Administration from Rockhurst University and a Bachelor of Arts in Business Administration and a Bachelor of Arts in Public Relations from William Jewell College.
“Joining the Tonix team presents an exciting and fulfilling opportunity to help advance a treatment for the millions of individuals with fibromyalgia,” said Mr. Ainsworth. “I look forward to providing additional expertise to a seasoned leadership team with the goal of bringing meaningful therapeutics to patients in need.”
At the end of December 2024, Tonix announced that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing authorization for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia. TNX-102 SL is a non-opioid, centrally-acting analgesic. Fibromyalgia is a common chronic pain condition that affects mostly women.
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 previously 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 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. In July 2024, Tonix 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 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
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ICR Healthcare
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(443) 213-0505
Media Contact
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Putnam Insights
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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 (Zembrance 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 TNXP's TNX-102 SL fibromyalgia treatment?
What is the value of TNXP's contract with the U.S. Department of Defense?
What commercial products does TNXP currently market?
What is the primary indication for TNXP's lead candidate TNX-102 SL?
