CHATHAM, N.J., Feb. 04, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the promotion of Siobhan Fogarty to Chief Technical Officer (CTO), effective immediately. Ms. Fogarty joined Tonix in 2016 and previously served as Executive Vice President of Product Development. Ms. Fogarty has over 25 years of experience in pharmaceutical and biotech product development, manufacturing and quality, for both small and large molecules, at notable pharmaceutical and biotech companies.
In December, 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) 5.6 mg for the management of fibromyalgia. TNX-102 SL is a non-opioid, centrally-acting analgesic. Fibromyalgia is a common chronic pain condition that affects mostly women.
“Siobhan is an invaluable member of our team and an outstanding leader who has contributed in many ways to our success since she joined in 2016, and we are excited that she is executing at a higher level in her new role as our first CTO,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Her energy, insights and organizational abilities will be welcome as we enter into a landmark time for the Company with the upcoming PDUFA goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia. In addition to her stewardship of TNX-102 SL, Siobhan has played key roles advancing our pipeline of small molecule, biologics and live-virus vaccines.”
Ms. Fogarty started her career with Elan Corporation as a formulation scientist where she gained experience in several different areas of drug delivery, including solid, liquids, IV, and transdermal formulations. At Elan, she took products from concept to commercial manufacture in both Ireland and the U.S. Ms. Fogarty moved to Glaxo SmithKline, London, as a manufacturing strategist after the merger of Glaxo and SmithKline Beecham. Returning to product development, Ms. Fogarty established European product development sites for Fuisz Technologies and Biovail Corporation, leading multi-disciplinary teams for the development of products from early conceptual/preclinical development, through the various clinical phases and transferring to U.S./Canadian manufacturing sites during registration for commercialization. Subsequently, Ms. Fogarty started a consultancy firm, eMSc, that advised pharmaceutical and biotech companies in product development and implementation of a phased approach to quality. Ms. Fogarty obtained her masters in Pharmaceutical Sciences at Trinity College, Dublin, and is a European Union Qualified Person. Her primary degree is in Industrial Chemistry from the University of Limerick where she interned at Pfizer.
“I am grateful for the incredible eight years I have already enjoyed working at Tonix and look forward to the challenges and opportunities of my new role,” said Ms. Fogarty. “Tonix is entering a momentous time, and it is an honor to assume these new responsibilities as part of this extraordinary team.”
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 also has product candidates in development in the area of 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 $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. 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; 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.
