Tonix Pharmaceuticals Holding Corp. has appointed Irina Ishak as General Counsel effective December 8, 2025, marking a strategic leadership addition during a pivotal period for the biotechnology company. Ishak, who previously served as Senior Counsel at Lowenstein Sandler LLP where she advised Tonix on financings, licensing, strategic transactions, commercial agreements and governance matters, will now lead the company's legal, corporate governance and compliance functions. Her appointment comes as Tonix commercializes its first FDA-approved fibromyalgia therapy in over 15 years and advances a diverse development portfolio spanning central nervous system disorders, immunology, rare diseases and infectious diseases.
The significance of this appointment extends beyond routine corporate governance. Ishak brings specific experience from her previous senior legal roles at Savient Pharmaceuticals, where she contributed to the development and launch of KRYSTEXXA, providing her with firsthand knowledge of the complex regulatory and commercial landscape facing pharmaceutical companies. CEO Seth Lederman emphasized that her corporate and transactional experience will be instrumental as Tonix executes its long-term strategy, particularly during the critical commercialization phase of its recently approved products. This leadership addition signals Tonix's commitment to strengthening its legal infrastructure as it navigates multiple regulatory pathways and potential market expansions.
Tonix's current portfolio includes FDA-approved TONMYA for fibromyalgia, a chronic pain condition affecting millions of adults, making it the first new prescription medicine approved for this condition in more than 15 years. The company also markets two acute migraine treatments: Zembrace SymTouch and Tosymra. Beyond marketed products, Tonix maintains an extensive development pipeline with candidates across multiple therapeutic areas. TNX-102 SL, the formulation investigated as TONMYA, is being developed for acute stress reaction and acute stress disorder through an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense, with additional development for major depressive disorder.
The company's immunology portfolio includes TNX-1500, a Phase 2-ready Fc-modified humanized monoclonal antibody targeting CD40-ligand being developed for prevention of allograft rejection and treatment of autoimmune diseases. In rare diseases, TNX-2900 (intranasal oxytocin potentiated with magnesium) is in development for Prader-Willi syndrome with a potential pivotal Phase 2 study expected to start in 2026. Infectious disease candidates include TNX-801, a vaccine in development for mpox and smallpox, and TNX-4800, a Phase 2-ready long-acting humanized monoclonal antibody for seasonal prevention of Lyme disease. Additionally, TNX-4200 has a contract with the U.S. DoD's Defense Threat Reduction Agency for up to $34 million over five years as a broad-spectrum antiviral agent targeting CD45 for prevention or treatment of high lethality infections to improve military medical readiness.
Ishak's appointment as General Counsel represents a strategic investment in legal expertise that will support Tonix across this complex portfolio. Her experience with regulatory compliance, intellectual property protection, and commercial agreements will be crucial as the company advances multiple candidates through clinical development while simultaneously commercializing approved products. The timing coincides with Tonix operating its state-of-the-art infectious disease research facility in Frederick, Maryland, further expanding its research capabilities. For investors and stakeholders, this leadership addition reinforces Tonix's commitment to robust governance as it transitions from a development-focused to a commercial-stage biotechnology company with multiple revenue streams and advanced pipeline candidates.
