Tonix Pharmaceuticals Appoints Irina Ishak as General Counsel During Commercial Expansion Phase

Tonix Pharmaceuticals Holding Corp. has appointed Irina Ishak as General Counsel effective December 8, 2025, positioning the biotechnology company with strengthened legal leadership during a period of commercial expansion and pipeline advancement. Ishak, who previously served as Senior Counsel at Lowenstein Sandler LLP where she advised Tonix on various legal matters, will now lead the company's legal, corporate governance and compliance functions internally.

The appointment comes at a significant time for Tonix, which recently launched TONMYA, the first FDA-approved fibromyalgia therapy in more than 15 years. CEO Seth Lederman emphasized that Ishak's corporate and transactional experience will be valuable as the company commercializes products, advances its development pipeline and executes its long-term strategic vision. Ishak brings previous experience from senior legal roles at Savient Pharmaceuticals, where she contributed to the development and launch of KRYSTEXXA.

Tonix's current commercial portfolio includes TONMYA for fibromyalgia, along with two acute migraine treatments: Zembrace SymTouch and Tosymra. The company's development pipeline spans multiple therapeutic areas, including central nervous system disorders, immunology, immuno-oncology, rare diseases and infectious diseases. According to company information available at https://ibn.fm/TNXP, Tonix's investigational candidates include TNX-102 SL for acute stress reaction and major depressive disorder, TNX-1500 for organ transplant rejection and autoimmune diseases, TNX-2900 for Prader-Willi syndrome, TNX-801 for mpox and smallpox prevention, TNX-4800 for Lyme disease prevention, and TNX-4200 for broad-spectrum antiviral applications.

The company's infectious disease research facility in Frederick, Maryland supports its development programs, including TNX-4200, which has a contract with the U.S. Department of Defense's Defense Threat Reduction Agency for up to $34 million over five years. This program aims to develop treatments for high lethality infections to improve military medical readiness in biological threat environments.

Ishak's appointment represents a strategic move to bolster Tonix's legal capabilities as the company navigates the complexities of commercializing newly approved therapies while advancing multiple investigational candidates through clinical development. The timing coincides with what Ishak described as a "pivotal period" for the company following its recent therapeutic launch. The full details of the announcement were made available through a press release accessible at https://ibn.fm/UH3pO.

For the biotechnology industry, executive appointments of experienced legal professionals with specific therapeutic area expertise signal companies' preparation for increased regulatory interactions, intellectual property management, and partnership negotiations that accompany product commercialization and pipeline expansion. Tonix's diverse portfolio across multiple therapeutic areas presents complex legal considerations ranging from regulatory compliance to licensing agreements and strategic transactions.

The company's focus on both commercial products and investigational candidates creates a multifaceted legal environment requiring expertise in pharmaceutical regulations, corporate governance, and transactional law. As Tonix advances its development programs, including potential pivotal studies for rare disease treatments and Phase 2-ready candidates for autoimmune conditions and infectious diseases, robust legal leadership becomes increasingly critical for navigating the regulatory landscape and protecting intellectual property assets.