TNXP Tonix Pharmaceuticals Holding Corp.
Legal ·
Dr. Reddy's told Tonix on October 1, 2026 that it filed an ANDA for a generic version of TONMYA 2.8 mg sublingual tablets and certified that four Orange Book patents are invalid, unenforceable or not infringed. No lawsuit has been filed, and Tonix says it intends to enforce its rights.
Tonix set up two ways to sell new stock on June 11, 2025: up to $150.0 million through A.G.P./Alliance Global Partners and up to $75.0 million to Lincoln Park Capital Fund. Its lead drug has an FDA decision date of August 15, 2025.
Tonix Pharmaceuticals is a fully integrated biopharmaceutical company commercializing and developing innovative therapies for central nervous system disorders, immunology, infectious diseases and rare diseases. Its first internally developed product, TONMYA (cyclobenzaprine HCl sublingual tablets), was approved by the FDA in August 2025 for fibromyalgia in adults and launched on November 17, 2025. Tonix also markets two FDA-approved acute migraine products, Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray). Its TNX-102 SL formulation is being explored in Phase 2 trials for major depressive disorder and acute stress disorder, and a Phase 2 study in major depressive disorder is expected to start in mid-2026. Other clinical programs include TNX-1500, a humanized antibody targeting CD40-ligand for kidney transplant rejection and autoimmune diseases, and TNX-1300, a cocaine esterase in Phase 2 for cocaine intoxication that holds Breakthrough Therapy designation. TNX-4800, a Lyme disease prevention antibody, and TNX-2900, for Prader-Willi syndrome, are also in its pipeline.
| Product or program | What it is | Stage |
|---|---|---|
| TONMYA (cyclobenzaprine HCl sublingual tablets) | Non-opioid analgesic for fibromyalgia in adults | approved in the US |
| Zembrace SymTouch (sumatriptan injection) | Acute migraine treatment | approved in the US |
| Tosymra (sumatriptan nasal spray) | Acute migraine treatment | approved in the US |
| TNX-102 SL | Cyclobenzaprine sublingual tablet explored for depression and stress disorders | Phase 2 |
| TNX-1500 | Humanized antibody targeting CD40-ligand for transplant rejection and autoimmune diseases | Phase 2-ready |
| TNX-1300 | Double-mutant cocaine esterase for cocaine intoxication | Phase 2 |
| Line | FY2025 | FY2024 |
|---|---|---|
| Revenue | $13.1 million | $10.1 million |
| Research and development | $44.5 million | $40.0 million |
| Net income (loss) | -$124.0 million | -$130.0 million |
| Cash from operations | -$99.8 million | -$60.9 million |
| Cash and equivalents | $207.6 million | $98.8 million |
Our latest story on this, dated Oct 2, 2026: "Tonix gets Paragraph IV patent notice from Dr. Reddy's on generic TONMYA application". The story links the filing or release it is based on. Read the story.
Tonix Pharmaceuticals Holding Corp. trades under the ticker TNXP on NASDAQ.
Tonix Pharmaceuticals Holding Corp. is listed on NASDAQ. Our directory also records these other listings: LS:A40VM0; LSX:A40VM0.
The SEC Central Index Key (CIK) for Tonix Pharmaceuticals Holding Corp. is 1430306. Its filings are on SEC EDGAR.
17,151,024 shares as of 2026-08-07, per the cover page of its 10-Q filed 2026-08-10.
Our directory records Tonix Pharmaceuticals Holding Corp. under United States.
Our directory classifies Tonix Pharmaceuticals Holding Corp. as: Pharmaceuticals: Major. This is a directory classification, not a description of the pipeline.
The ISIN recorded for Tonix Pharmaceuticals Holding Corp. is US8902608392.
aibio.space lists Tonix Pharmaceuticals Holding Corp. among 2,820 public biotech companies and publishes its news here as stories appear.
SEC records list its state or country of incorporation as NV.
Tonix Pharmaceuticals is a fully integrated biopharmaceutical company commercializing and developing innovative therapies for central nervous system disorders, immunology, infectious diseases and rare diseases. Its first internally developed product, TONMYA (cyclobenzaprine HCl sublingual tablets), was approved by the FDA in August 2025 for fibromyalgia in adults and launched on November 17, 2025.
TONMYA (cyclobenzaprine HCl sublingual tablets): Non-opioid analgesic for fibromyalgia in adults Stage: approved in the US.
Zembrace SymTouch (sumatriptan injection): Acute migraine treatment Stage: approved in the US.
$13.1 million for the fiscal year ended Dec 31, 2025, as reported to the SEC.
Tonix Pharmaceuticals Holding Corp. reported a net loss of $124.0 million for the fiscal year ended Dec 31, 2025, and used $99.8 million of cash in operations, per its annual report to the SEC.
Reported a shareholder vote on a reverse stock split or more authorized shares. SEC Form 8-K (Items 5.02,5.07,9.01). Source
Asked shareholders to approve a reverse stock split. SEC Form DEF 14A. Source
Asked shareholders to approve a reverse stock split. SEC Form PRE 14A. Source
Reported a change of independent auditor. SEC Form 8-K (Items 4.01,9.01). Source
Reported substantial doubt about its ability to continue as a going concern. SEC Form 10-K. Source
Reported a financing. SEC Form 424B5. Source
Reported a financing. SEC Form 8-K (Items 1.01,8.01,9.01). Source
Announced a share repurchase program. SEC Form 8-K (Items 8.01). Source
Reported a financing. SEC Form 8-K (Items 1.01,9.01). Source
Reported a shareholder vote on a reverse stock split or more authorized shares. SEC Form 8-K (Items 5.07). Source
Asked shareholders to approve a reverse stock split. SEC Form DEF 14A. Source
Asked shareholders to approve a reverse stock split. SEC Form PRE 14A. Source
Reported a notice from its stock exchange about continued listing requirements. SEC Form 8-K (Items 8.01). Source
Reported a financing. SEC Form 8-K (Items 7.01,9.01). Source
Reported a reverse stock split. SEC Form 8-K (Items 1.02,2.02,3.03,8.01,9.01). Source
Filed a final prospectus for a securities offering. SEC Form 424B5. Source
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