
Tonix Pharmaceuticals Appoints Siobhan Fogarty as Chief Technical Officer
Tonix Pharmaceuticals Holding a fully integrated biopharmaceutical company specializing in the development and commercialization of innovative therapies for pain management and other health challenges, has announced the promotion of Siobhan Fogarty to Chief Technical Officer (CTO), effective immediately.
Ms. Fogarty, who has been an integral part of Tonix Pharmaceuticals since joining in 2016, previously held the role of Executive Vice President of Product Development. With over 25 years of experience in pharmaceutical and biotech product development, manufacturing, and quality control for both small and large molecules, she has played a critical role in advancing Tonix’s portfolio. Her leadership and expertise have been pivotal in ensuring the successful progression of numerous development candidates, strengthening the company’s position within the biopharmaceutical industry.

Milestone Achievements in Fibromyalgia Treatment Development
Tonix has been making significant strides in the field of central nervous system (CNS) disorders. In December, the company announced that the U.S. Food and Drug Administration (FDA) had 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. This non-opioid, centrally acting analgesic is being developed for the management of fibromyalgia, a chronic pain condition that primarily affects women. The potential approval of TNX-102 SL represents a major milestone for Tonix and underscores the company’s commitment to addressing the unmet medical needs of fibromyalgia patients.
“Siobhan Pharmaceuticals is an invaluable member of our team and an outstanding leader who has contributed significantly to our success since she joined in 2016. We are excited to see her excel in her new role as our first Chief Technical Officer,” said Dr. Seth Lederman, President and Chief Executive Officer of Tonix Pharmaceuticals. “Her energy, insights, and organizational abilities will be instrumental as we navigate this landmark period for the company with the upcoming PDUFA goal date for TNX-102 SL. In addition to her oversight of TNX-102 SL, Siobhan has played key roles in advancing our pipeline of small molecule drugs, biologics, and live-virus vaccines.”
Siobhan Fogarty’s Extensive Experience in the Pharmaceutical Industry
Ms. Fogarty began her career at Elan Corporation as a formulation Pharmaceuticals scientist, where she gained experience in various drug delivery technologies, including solid, liquid, intravenous, and transdermal formulations. During her tenure at Elan, she contributed to taking products from concept to commercial manufacturing in both Ireland and the United States.
Following the merger of Glaxo and SmithKline Beecham, Ms. Fogarty joined GlaxoSmithKline in London as a manufacturing strategist, where she played a critical role in aligning the company’s manufacturing strategies with product development goals. Returning to product development, she went on to establish European product development sites for Fuisz Technologies and Biovail Corporation, leading multidisciplinary teams in the early conceptual and preclinical phases through various clinical stages and ultimately transferring products to U.S. and Canadian manufacturing sites for regulatory approval and commercialization.
Ms. Fogarty later founded eMSc, a consultancy firm that advised pharmaceutical and biotech companies on product development strategies and the implementation of phased approaches to quality control. Her extensive background in pharmaceutical sciences is further complemented by her academic achievements. She obtained a master’s degree in Pharmaceutical Sciences from Trinity College, Dublin, and holds a primary degree in Industrial Chemistry from the University of Limerick, where she interned at Pfizer. Additionally, she is recognized as a European Union Qualified Person, a designation that enables her to oversee the production and release of pharmaceutical products in compliance with EU regulations.
Expanding Responsibilities and Future Prospects
Expressing her gratitude and enthusiasm for her new role, Ms. Fogarty stated, “I am honored to have been part of Tonix Pharmaceuticals for the past eight years and to have had the opportunity to contribute to the company’s remarkable growth. As we enter a momentous time with the potential approval of TNX-102 SL, I look forward to taking on new challenges and working alongside our talented team to drive innovation and excellence in product development.”
As CTO, Ms. Fogarty will be responsible for overseeing the technical Pharmaceuticals aspects of Tonix’s expanding portfolio, ensuring the seamless integration of research, development, and manufacturing operations. Her leadership will be instrumental in advancing the company’s diverse pipeline, which encompasses treatments for CNS disorders, infectious diseases, and immunology-related conditions.
Tonix Pharmaceuticals: A Leader in Biopharmaceutical Innovation
Tonix Pharmaceuticals is a fully integrated biopharmaceutical company focused on transforming therapies for pain management, infectious diseases, and other public health challenges. The company’s research and development efforts are primarily concentrated on CNS disorders, with a strong emphasis on advancing TNX-102 SL as a treatment for fibromyalgia. The investigational drug has received Fast Track designation from the FDA and is supported by two statistically significant Phase 3 studies demonstrating its efficacy for fibromyalgia management.
Beyond fibromyalgia, Tonix is exploring additional indications for TNX-102 SL, including acute stress reaction and acute stress disorder. The company is also engaged in the development of TNX-1300, a biologic in Phase 2 trials designed to treat cocaine intoxication. This program has received Breakthrough Therapy designation from the FDA and is supported by funding from the National Institute on Drug Abuse (NIDA).
Tonix’s immunology pipeline includes TNX-1500, an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154), which is being developed for preventing organ transplant rejection and treating autoimmune diseases. Additionally, Tonix is developing TNX-801, a vaccine candidate for mpox, and TNX-4200, a broad-spectrum antiviral agent targeting CD45 for infection prevention and treatment. The TNX-4200 program recently received a contract from the U.S. Department of Defense’s Defense Threat Reduction Agency (DTRA), with potential funding of up to $34 million over five years.
The company operates a state-of-the-art infectious disease research facility in Frederick, Maryland, and continues to expand its capabilities to develop cutting-edge therapeutics. Tonix Medicines, the company’s commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray) for the acute treatment of migraines in adults.