Welcome to our dedicated page for Tonix Pharmaceut SEC filings (Ticker: TNXP), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Tonix Pharmaceuticals Holding Corp. (TNXP) SEC filings page on Stock Titan provides direct access to the company’s regulatory disclosures as filed with the U.S. Securities and Exchange Commission. Tonix is a Nevada corporation with common stock listed on The Nasdaq Capital Market under the symbol TNXP, and it uses Forms 8-K, 10-Q, 10-K and registration statements to report material events, financial results and securities offerings related to its commercial-stage biotechnology business.
For Tonix, current and prospective shareholders often focus on filings that explain the commercialization of its FDA-approved fibromyalgia medicine TONMYA, net product revenue from its acute migraine therapies Zembrace SymTouch and Tosymra, and the funding of its development portfolio in CNS disorders, immunology, rare disease and infectious disease. Form 8-K reports detail events such as FDA IND clearance for TNX-102 SL in major depressive disorder, licensing of TNX-4900 for chronic neuropathic pain, collaborations on TNX-1500 for kidney transplant rejection, and capital markets activities including amendments to sales agreements, registered direct offerings and share repurchase authorizations.
On this page, you can review quarterly reports (Form 10-Q) and annual reports (Form 10-K) for Tonix’s consolidated financial statements, risk factor discussions and descriptions of its product pipeline. Current reports on Form 8-K highlight specific milestones, while shelf registration statements and prospectus supplements describe the terms of equity offerings used to finance commercialization and clinical development. Insider transaction reports on Form 4, when available, help investors see how Tonix officers and directors are trading the company’s stock.
Stock Titan enhances these TNXP filings with AI-powered summaries that highlight key points, such as changes in cash runway, material agreements, clinical development plans and securities issuance. Real-time updates from EDGAR mean new Tonix filings appear promptly, while AI-generated explanations can save time for readers who want to understand the implications of lengthy documents like 10-Ks, 10-Qs or complex 8-K exhibits without reading every page.
Tonix Pharmaceuticals (TNXP) filed an 8-K with preliminary updates. The company believes its cash at September 30, 2025, plus $29.3 million of net proceeds from equity offerings in the fourth quarter of 2025, will cover planned operating and capital needs into the first quarter of 2027.
Management emphasized these are unaudited, preliminary estimates subject to completion of closing procedures and potential adjustments. The independent auditor has not audited, reviewed, or compiled this information. Tonix currently expects to file its Form 10-Q for the quarter ended September 30, 2025, on or about November 10, 2025.
The company also expects to commence the U.S. commercial launch of Tonmya for the treatment of fibromyalgia in adults by the end of November 2025.
Tonix Pharmaceuticals (TNXP) announced the first patient was dosed in the investigator-initiated FOCUS study at Massachusetts General Hospital in adults with arginine-vasopressin deficiency (AVP-D).
The randomized, double-blind, placebo-controlled crossover pilot will evaluate single-dose intranasal potentiated oxytocin at two doses: 6 IU (TNX-2900) and 24 IU (TNX-1900). The study will assess markers of anxiety, depression, and socioemotional functioning, with an exploratory two-week replacement period to observe mental health outcomes.
Tonix Pharmaceuticals Holding Corp. filed an 8-K to share an updated investor presentation and outline upcoming clinical plans. The company intends to start a Phase 2 trial in 2026 of its TNX-102 SL product candidate, already approved for fibromyalgia, for treating major depressive disorder. Tonix also plans an adaptive Phase 2/3 study in 2027 of TNX-4800 for the seasonal prevention of Lyme disease. The presentation is furnished as Exhibit 99.01 and is not deemed filed for liability purposes under U.S. securities laws.
Tonix Pharmaceuticals Holding Corp. appointed Ganesh Kamath as Head of Market Access, effective September 29, 2025. This role typically focuses on how medicines are reimbursed and accessed by patients through insurers and health systems.
The company also set the wholesale acquisition cost for Tonmya, its treatment for fibromyalgia in adults, at $1,860 per month for a 60‑count supply. For geriatric adults and adults with mild hepatic impairment, the wholesale acquisition cost is $930 per month for a 30‑count supply. These list prices form the starting point for insurer and pharmacy discount negotiations.
Tonix Pharmaceuticals Holding Corp. reported a material event on September 29, 2025 by filing an Form 8-K under Item 8.01 to disclose a press release titled "TNX-2900 Product Presentation Cover Page". The filing indicates the press release and an interactive data file (Inline XBRL) are included as part of the submission. The document is signed by Bradley Saenger, Chief Financial Officer, and the filing notes written communications under Rule 425 and pre-commencement communications under Rule 14d-2(b).
Tonix Pharmaceuticals Holding Corp. reported that it completed a Type B Pre‑Investigational New Drug (Pre‑IND) meeting with the U.S. Food and Drug Administration for its TNX‑102 SL sublingual tablet, being developed for the treatment of major depressive disorder (MDD).
Based on feedback from the FDA, the company plans to pursue a supplemental new drug application to expand the therapeutic indication of TNX‑102 SL to include MDD, using exploratory findings that link improved sleep quality with better depressive symptoms. The FDA considered Tonix’s proposed long‑term safety data collection plan generally reasonable, which may streamline development. An Investigational New Drug filing for TNX‑102 SL in MDD is planned for the fourth quarter of 2025, with Phase 2 clinical trials expected to begin shortly thereafter.
Tonix Pharmaceuticals Holding Corp. reported that it completed a Type B Pre‑Investigational New Drug (Pre‑IND) meeting with the U.S. Food and Drug Administration for its TNX‑102 SL sublingual tablet, being developed for the treatment of major depressive disorder (MDD).
Based on feedback from the FDA, the company plans to pursue a supplemental new drug application to expand the therapeutic indication of TNX‑102 SL to include MDD, using exploratory findings that link improved sleep quality with better depressive symptoms. The FDA considered Tonix’s proposed long‑term safety data collection plan generally reasonable, which may streamline development. An Investigational New Drug filing for TNX‑102 SL in MDD is planned for the fourth quarter of 2025, with Phase 2 clinical trials expected to begin shortly thereafter.
Tonix Pharmaceuticals Holding Corp. filed a report describing that it has in-licensed worldwide rights to TNX-4800, a long-acting fully human monoclonal antibody targeting the outer surface protein A (OspA) of Borrelia burgdorferi, the bacterium that causes Lyme disease in humans. TNX-4800 is engineered for an extended half-life and is designed as a single subcutaneous springtime dose to maintain protective antibody levels through the U.S. tick season, providing pre-exposure prophylaxis without relying on the recipient’s immune system to make antibodies.
The company notes that TNX-4800 has been shown to block transmission of major Borrelia genospecies from ticks to animals and may avoid the multidose schedules used for OspA vaccines in development and previously approved vaccines that were withdrawn over autoimmunity concerns. Tonix intends to advance TNX-4800 through additional clinical trials with the goal of submitting a Biologics License Application to the U.S. Food and Drug Administration.
Tonix Pharmaceuticals Holding Corp. filed Amendment No. 1 to its S-3 registration statement (File No. 333-287965) as an exhibits-only amendment to re-file Exhibit 23.1. This Amendment does not modify any provision of the prospectus that forms part of the Registration Statement.
The Amendment consists solely of the facing page, this explanatory note, Item 16 of Part II, the signature pages, the exhibits index and the re-filed Exhibit 23.1.
Tonix Pharmaceuticals Holding Corp. filed Amendment No. 1 to its S-3 registration statement (File No. 333-287965) as an exhibits-only amendment to re-file Exhibit 23.1. This Amendment does not modify any provision of the prospectus that forms part of the Registration Statement.
The Amendment consists solely of the facing page, this explanatory note, Item 16 of Part II, the signature pages, the exhibits index and the re-filed Exhibit 23.1.
Tonix Pharmaceuticals Holding Corp. filed Amendment No. 1 to its S-3 registration statement (File No. 333-287965) as an exhibits-only amendment to re-file Exhibit 23.1. This Amendment does not modify any provision of the prospectus that forms part of the Registration Statement.
The Amendment consists solely of the facing page, this explanatory note, Item 16 of Part II, the signature pages, the exhibits index and the re-filed Exhibit 23.1.
Tonix Pharmaceuticals insider purchase by Director Carolyn E. Taylor: The reported transaction shows Director Carolyn E. Taylor acquired 418 shares of Tonix Pharmaceuticals Holding Corp. common stock at a weighted-average purchase price of $36.03 per share, with individual purchase prices ranging from $35.98 to $36.05. The transaction is reported as a direct purchase under Rule 16 reporting. The filing was submitted by an attorney-in-fact on behalf of the reporting person. No derivative transactions, dispositions, or additional holdings beyond the 418 shares are disclosed in this Form 4.
Tonix Pharmaceuticals (TNXP) director James Treco purchased 250 shares of the company common stock on 08/20/2025 at a reported price of $36 per share. Following the purchase, Mr. Treco directly beneficially owned 250 shares. The transaction was reported on a Form 4 and signed by an attorney-in-fact.