Tonix Pharmaceuticals Holding Corp. announced on September 8, 2026, the promotion of Thomas Englese to Chief Commercial Officer, effective immediately. Mr. Englese previously served as Executive Vice President, Commercial Operations since September 2024 and will continue directing sales, marketing, market access, and commercial operations for TONMYA (cyclobenzaprine HCl sublingual tablets) for fibromyalgia, as well as Zembrace SymTouch and Tosymra for acute migraine. Tonix Pharmaceuticals Holding Corp. is a fully integrated, commercial-stage biopharmaceutical company focused on central nervous system disorders, infectious diseases, and immunology conditions.

On August 18, 2026, Tonix Pharmaceuticals Holding Corp. appointed President and CEO Dr. Seth Lederman as Interim Chief Medical Officer. Dr. Lederman will continue serving in his existing roles as President, CEO, and Chairman of the Board. This appointment is an internal administrative change with no impact on corporate strategy or financial condition. Tonix Pharmaceuticals Holding Corp. operates in the biopharmaceutical industry, focusing on the development of immunotherapies for autoimmune diseases.

Tonix Pharmaceuticals Holding Corp. reported second quarter 2026 operating results, announcing net product revenue of approximately $13.5 million, a significant increase from $2.0 million in the prior year period. Net sales of its flagship fibromyalgia treatment TONMYA totaled approximately $11 million, reflecting a 197% quarter-over-quarter growth driven by expanded payer coverage reaching 136 million covered lives and prescription volume doubling to 12,592 units. The company reported a net loss of $40.6 million, or $2.44 per share, compared to a $28.3 million loss in the same period last year, as R&D and SG&A expenses rose due to commercial launch investments and clinical trial costs. Tonix ended the quarter with approximately $176.2 million in cash and cash equivalents.

Tonix Pharmaceuticals Holding Corp. announced receipt of official minutes from a Type C meeting with the U.S. Food and Drug Administration regarding its adaptive Phase 2 field study for TNX-4800, a monoclonal antibody intended to prevent Lyme disease in adults. The FDA aligned with the company on a randomized, placebo-controlled design enrolling approximately 3,300 participants from Lyme-endemic areas over two seasons. The primary efficacy endpoint is prevention at six months post-dose, with safety evaluated over 52 weeks. Participants will receive TNX-4800 450 mg subcutaneously or placebo in a two-dose regimen spaced three months apart. Investigational product delivery to study sites is scheduled for the first quarter of 2027, with enrollment expected primarily in the 2028 season. Tonix Pharmaceuticals Holding Corp. operates as a commercial-stage biotechnology company focused on central nervous system disorders, infectious diseases, immunology conditions, and rare diseases.

Dr. Gregory M. Sullivan will retire from his role as Chief Medical Officer, effective August 20, 2026. Tonix Pharmaceuticals Holding Corp. is a biopharmaceutical company focused on developing and treating various medical conditions.

Tonix Pharmaceuticals Holding Corp. entered into an agreement with a pharmacy benefit manager to provide coverage for TONMYA to approximately 9 million Medicare Part D plan beneficiaries effective January 1, 2027. This agreement expands the coverage of the company's product TONMYA from Medicaid coverage in most states to a total expected coverage of approximately 145 million individuals across government and and commercial channels. Tonix Pharmaceuticals Holding Corp. is a pharmaceutical company that develops and commercializes commercial products for various medical conditions.