TONIX PHARMACEUTICALS HOLDING CORP.

What TONIX PHARMACEUTICALS HOLDING CORP. does

Tonix Pharmaceuticals Holding Corp. is a commercial-stage biotechnology company (Nasdaq: TNXP) headquartered in Berkeley Heights, New Jersey, that develops and markets pharmaceutical products for central nervous system disorders, infectious diseases, immunology, and rare diseases. Its marketed portfolio includes TONMYA (cyclobenzaprine HCl sublingual tablets 2.8mg), the first new FDA-approved prescription medicine for fibromyalgia in adults in over 15 years, commercially launched November 17, 2025, plus the acute migraine therapies Zembrace SymTouch (sumatriptan injection 3mg) and Tosymra (sumatriptan nasal spray 10mg) acquired from Upsher-Smith Laboratories in July 2023.

The company's technology platform spans three distinct modalities. Its proprietary sublingual/transmucosal drug delivery system, using potassium phosphate dibasic as a basifying agent, achieves approximately 154% relative bioavailability versus oral immediate-release cyclobenzaprine with absorption in approximately 3 minutes versus 37 minutes for oral delivery, bypassing first-pass hepatic metabolism. In biologics, TNX-1500 is a third-generation Fc-modified IgG4 anti-CD40L monoclonal antibody with a mean terminal half-life of 33.8-37.8 days, and TNX-4800 is a long-acting anti-OspA mAb with a 62-69 day half-life targeting seasonal Lyme disease prevention. TNX-801 is a synthesized horsepox-based live virus vaccine platform for mpox and smallpox. The pipeline is anchored by a 48,000 sq ft BSL-2/BSL-3 R&D Center in Frederick, Maryland and approximately 51-100 employees across CNS, infectious disease, and immunology programs.

Tonix monetizes through commercial pharmaceutical product sales distributed via retail pharmacy and GPO/Medicaid contracts, plus government development contracts including a $34 million U.S. Department of Defense award for TNX-4200. Commercial payer coverage extends to approximately 52 million U.S. commercial lives and Medicaid coverage to approximately 55 million lives across 38 states. Pricing follows traditional pharmaceutical commercial and Medicaid negotiation and is not publicly disclosed. The company supplements operating capital through recurring equity financings, most recently a $20 million registered direct offering with Point72 Asset Management in December 2025, and ended 2025 with $207.6 million in cash and a net loss of approximately $124 million.

Name

TONIX PHARMACEUTICALS HOLDING CORP.

Legal name

Tonix Pharmaceuticals Holding Corp.

Website

https://tonixpharma.com

Company type

Public

Founded year

2011

Operating status

Operating

Headcount range

101–250 employees

Short description

Tonix Pharmaceuticals Holding Corp. is a commercial-stage biotechnology company that develops and markets CNS, infectious disease, immunology, and rare disease therapies, with TONMYA for fibromyalgia and Zembrace SymTouch and Tosymra for acute migraine as its lead marketed products.

Ownership category

akta.pro rank

Product category

Specialty Biopharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

akta.pro secondary industries

Monoclonal Antibody Therapeutics (mAbs) (HLAAAAAA), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB), Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF)

Keywords

• Central nervous system therapeutics
• Biopharmaceutical drug development
• Fibromyalgia prescription treatments
• Infectious disease vaccines
• Monoclonal antibody therapies

Headquarters

HQ city

Chatham

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Marketing or Sales, Operations, Others

Revenue model

1. Product Sales - TONMYA: Net product revenue from TONMYA (cyclobenzaprine HCl sublingual tablets) for fibromyalgia, FDA-approved August 2025 and commercially launched November 2025. Generated $1.4 million in revenue from November 17, 2025 launch through year-end 2025.
2. Product Sales - Acute Migraine Treatments: Revenue from marketed acute migraine products Zembrace SymTouch (sumatriptan injection 3mg) and Tosymra (sumatriptan nasal spray 10mg), acquired from Upsher-Smith Laboratories in July 2023.
3. Government Contracts: $34 million contract with the U.S. Department of Defense for development of TNX-4200 and grant from Medical CBRN Defense Consortium (MCDC) for development of TNX-801 mpox and smallpox vaccine candidate.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

Tonix Pharmaceuticals is a commercial-stage biopharmaceutical company that develops, manufactures, and commercializes prescription therapeutics for central nervous system disorders, infectious diseases, immunology/immuno-oncology, and rare diseases. Its marketed portfolio includes TONMYA (cyclobenzaprine HCl sublingual tablets) for fibromyalgia, and the acquired acute migraine products Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray). The company is advancing a diversified pipeline of small molecules, monoclonal antibodies, and live virus vaccines targeting fibromyalgia, major depressive disorder, acute stress disorder, Lyme disease, mpox/smallpox, organ transplant rejection, and Prader-Willi syndrome.

Product overview

Tonix Pharmaceuticals is a commercial-stage biotechnology company with a portfolio of FDA-approved products and a diverse pipeline of development candidates. Its marketed products include TONMYA (cyclobenzaprine HCl sublingual tablets) for fibromyalgia, Zembrace SymTouch and Tosymra for acute migraine. The company is advancing pipeline candidates across CNS disorders (TNX-102 SL for MDD and acute stress disorder), infectious diseases (TNX-4800 for Lyme disease prevention, TNX-801 for mpox/smallpox), immunology/immuno-oncology (TNX-1500 for transplant rejection, TNX-1700 and TNX-4700 for cancer), and rare diseases (TNX-2900 for Prader-Willi syndrome).

Differentiator

Problem solved

Functional benefit

Brands

• Tonix Medicines: Subsidiary handling commercial operations for marketed products including Zembrace SymTouch and Tosymra
• TONMYA
• Zembrace SymTouch
• Tosymra

Products and services

• TONMYA (cyclobenzaprine HCl sublingual tablets 2.8mg) FDA-approved sublingual tablet formulation of cyclobenzaprine for bedtime use in adults with fibromyalgia. Designed for rapid transmucosal absorption (~3 minutes vs ~37 minutes oral) and 154% relative bioavailability vs oral immediate-release cyclobenzaprine, bypassing first-pass hepatic metabolism. Targets non-restorative sleep and chronic widespread pain.
• Zembrace SymTouch (sumatriptan injection 3mg) FDA-approved acute migraine treatment delivered via 3mg subcutaneous sumatriptan injection. Acquired marketed product for acute migraine episodes.
• Tosymra (sumatriptan nasal spray 10mg) FDA-approved acute migraine treatment delivered via 10mg sumatriptan nasal spray. Acquired marketed product for acute migraine episodes.
• TNX-4800 (long-acting anti-OspA monoclonal antibody) Long-acting monoclonal antibody for seasonal prevention of Lyme disease in adolescents and adults aged 16-65 in Lyme-endemic areas (~70 million Americans). Designed for ~4-month protection with measurable serum concentrations up to 12 months.
• TNX-801 (synthesized horsepox live virus vaccine) Single-dose live attenuated vaccine candidate for prevention of mpox and smallpox, based on synthesized horsepox virus. Designed for durable immune protection with improved tolerability vs existing vaccines. Targets biodefense and global unmet needs for mpox prevention.
• TNX-1500 (Fc-modified anti-CD40L monoclonal antibody) Third-generation Fc-modified IgG4 anti-CD40L (CD154) monoclonal antibody for prevention of organ transplant rejection and treatment of autoimmune diseases. Engineered to improve safety vs first-generation anti-CD40L mAbs while preserving durable half-life.
• TNX-1700 (TFF2-albumin fusion protein) TFF2-albumin fusion protein for gastro-intestinal cancers (gastric and colorectal cancer) and immuno-oncology applications.
• TNX-4700 (anti-BTLA monoclonal antibody)

Quantifiable outcome

• TONMYA achieved statistical significance for pain reduction in Phase 3 RESILIENT trial (457 patients over 14 weeks)
• +3 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Four partnerships are on record, tiered core.

• Rutgers UniversitycoreStrategic or Co-development Partner · 16 December 2025Licensed exclusive worldwide rights to TNX-4900, a Sigma-1 receptor antagonist developed from Rutgers University research showing potential as a non-opioid analgesic for chronic neuropathic pain. Demonstrated efficacy in animal pain models with encouraging safety profiles. Company plans to advance TNX-4900 through studies toward IND-enabling development.
• Massachusetts General Hospital (MGH)coreStrategic or Co-development Partner · 4 November 2025Collaboration to conduct a Phase 2 investigator-initiated clinical trial evaluating TNX-1500 (Fc-modified anti-CD40L mAb) in kidney transplant recipients. Study to enroll five patients at MGH and follow them for 12 months, assessing safety and activity in preventing organ rejection while reducing reliance on calcineurin inhibitors. Study initiation planned for first half of 2026 pending FDA IND clearance. Also conducting investigator-initiated FOCUS study evaluating intranasal potentiated oxytocin products for Arginine-Vasopressin Deficiency (AVP-D).
• Medical CBRN Defense Consortium (MCDC)coreStrategic or Co-development Partner · 10 March 2025Grant awarded for development of TNX-801, a single-dose mpox and smallpox vaccine candidate based on synthesized horsepox virus. The vaccine aims to offer durable protection with improved tolerability, targeting global unmet needs for mpox prevention.
• Upsher-Smith Laboratories, LLCcoreStrategic or Co-development Partner · 1 July 2023Acquired two marketed migraine therapies, Zembrace SymTouch (sumatriptan injection 3mg) and Tosymra (sumatriptan nasal spray 10mg), in July 2023 to expand acute migraine treatment portfolio.

Scale indicators12 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Axsome Therapeutics: Commercial-stage CNS-focused biopharma with FDA-approved therapies (Auvelity for major depressive disorder, Sunosi for narcolepsy) and a pipeline targeting pain and neurology. Highly comparable to Tonix given its CNS specialization, recent product launches, and similar size/scale trajectory.
• Sage Therapeutics: CNS-focused biopharma with Zurzuvae (zuranolone) for postpartum depression and an active neurology pipeline. Comparable to Tonix in CNS therapeutic focus, FDA-approved CNS assets, and pipeline breadth across depression and rare neurological conditions.
• ACADIA Pharmaceuticals: Specialty CNS pharma commercializing Nuplazid for Parkinson's disease psychosis and DAYBUE for Rett syndrome. Comparable specialty pharma model with FDA-approved CNS assets and rare disease pipeline focus.
• Pacira BioSciences: Specialty pharma focused on non-opioid pain management with EXPAREL and iovera products. Comparable to Tonix in targeting the non-opioid pain treatment opportunity and CNS-adjacent pain indications.
• Collegium Pharmaceutical: Specialty pharma with pain and neurology commercial products (Xtampza, Belbuca, Jornay PM). Comparable CNS/pain commercial-stage company with similar scale and specialty distribution model.
• Biohaven Pharmaceutical: CNS-focused pharma with Nurtec ODT for migraine and an active neurology pipeline. Closely comparable in CNS focus and migraine market participation, with similar recent product launch profile.
• Bavarian Nordic: Vaccine company with JYNNEOS for mpox/smallpox (the current standard of care) and a pipeline targeting infectious diseases. Most directly comparable peer for Tonix's TNX-801 mpox/smallpox vaccine program and infectious disease franchise.

Broad incumbents

• Jazz Pharmaceuticals: Larger specialty biopharma with broad CNS franchise (Xywav, Epidiolex, Sunosi) and migraine presence. Comparable CNS specialty focus but with substantially larger commercial scale and diversified portfolio.
• AbbVie: Large incumbent pharma with Ubrelvy/Qulipta for migraine and a broader neurology/pain portfolio. Major competitor in the migraine space and broader CNS market where Tonix competes.
• Pfizer: Major pharma with Nurtec ODT for migraine, Lyrica for fibromyalgia/pain, and broad infectious disease/vaccine portfolio. Competes with Tonix in fibromyalgia, migraine, and biodefense vaccine markets as a broad incumbent.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/TONIXPharma
• Facebookfacebook.com/TonixPharma
• LinkedInlinkedin.com/company/tonix-pharmaceuticals

Revenue estimate

Valuation estimate

Number of profiles

Profiles19 records

Subsidiaries2 records

Funding overview

Funding rounds21 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about TONIX PHARMACEUTICALS HOLDING CORP.