Tonix Pharmaceuticals Holding Corp. discovers, acquires, develops, and licenses small molecules and biologics to treat and prevent human diseases and alleviate suffering. Its immunology product candidates include vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases; and central nervous system (CNS) product candidates comprise small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The company's lead vaccine candidate is TNX-1800, a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19. Its vaccines also comprise TNX-801, a live horsepox virus vaccine to protect against smallpox and monkeypox and serves as the vector platform; and TNX-2300 for the prevention of COVID-19. The company's lead CNS candidate is TNX-102 SL, a sublingual tablet formulation of cyclobenzaprine for fibromyalgia, and for the treatment of agitation in Alzheimer's disease, posttraumatic stress disorder (PTSD), and alcohol use disorder. Its products include TNX-1300 for the treatment of cocaine intoxication; TNX-601 CR for depression disorder, PTSD, and neurocognitive dysfunction from corticosteroids; and TNX-1900 for migraine and craniofacial pain treatment. Its preclinical pipeline includes TNX-1600 for PTSD, depression, and attention deficit hyperactivity disorder; TNX-1700 for gastric and pancreatic cancers; TNX-701 for radioprotection; TNX-1200, a smallpox vaccine; TNX-1500, a monoclonal antibody anti-CD40-L for organ transplant rejection autoimmunity; and TNX-2900, an intranasal potentiated oxytocin for the treatment of Prader-Willi syndrome. It also develops TNX-2100, a COVID-19 skin test. It has collaboration agreements with Southern Research Institute, Columbia University, the University of Alberta, and Massachusetts General Hospital. The company was incorporated in 2007 and is headquartered in Chatham, New Jersey.
IPO Year:
Exchange: NASDAQ
Website: tonixpharma.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 4/18/2022 | Outperform | Noble Capital Markets |
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Noble Capital Markets initiated coverage of Tonix Pharma with a rating of Outperform
Alliance Global Partners resumed coverage of Tonix Pharmaceuticals with a rating of Buy and set a new price target of $4.00 from $3.00 previously
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Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years Fibromyalgia is a chronic pain condition that affects more than 10 million adults in the U.S. who are mostly women Two Pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo; generally well tolerated Commercial availability of Tonmya is expected in the fourth quarter Company to host webcast and conference call on Monday August 18, 2025 at 8:30 AM ET CHATHAM, N.J., Aug. 15, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a fully-integrated biotechnology company, today announced that the U.S. Food and Drug Administratio
FDA PDUFA goal date of August 15, 2025, for TNX‑102 SL for fibromyalgia: if approved by FDA, TNX‑102 SL would be the first new drug for fibromyalgia in more than 16 years In June 2025, the Company was added to the Russell 3000® and Russell 2000® Indexes following the annual reconstitution Phase 3 RESILIENT results published in peer-reviewed journal, Pain Medicine, including statistically significant reduction in fibromyalgia pain with once‑nightly TNX‑102 SL; generally well tolerated Cash and cash equivalents of $125.3 million reported as of June 30, 2025; current cash runway expected to fund operations into the third quarter of 2026 CHATHAM, N.J., Aug. 11, 2025 (GLOBE NEWSWIRE) -- To
NetworkNewsWire Editorial Coverage NEW YORK, Aug. 6, 2025 /PRNewswire/ -- As the American population gets older, chronic and rare diseases are becoming a significant healthcare issue, particularly for older adults. The aging population's increasing life expectancy also leads to more complex healthcare needs, especially for conditions that are both chronic and difficult to diagnose. Many of these rare conditions lack FDA-approved treatments, and their symptoms in seniors are frequently mistaken for normal signs of aging, causing diagnostic delays that can last for years. There are more than 30 million Americans who have a rare disease, so there is a growing need for accurate diagnoses and eff
CHATHAM, N.J., July 21, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a fully-integrated biotechnology company, today announced that Tonix Medicines, Inc., its commercial subsidiary, launched the Move Fibro Forward campaign to bring awareness and support to individuals impacted by fibromyalgia, a debilitating condition with no new FDA-approved treatments in over 15 years. "Millions of individuals impacted by fibromyalgia have suffered in silence for far too long," said Thomas Englese, President of Tonix Medicines, Inc. "We believe that demonstrating our knowledge of, and compassion for, their condition and validation of their experience is an important step t
TNX-801 is up to 100,000-fold less virulent than live smallpox vaccine strains and a single dose provides robust immunogenicity and protection against mpox and rabbitpox (more than one year) in animals Subcutaneous administration of TNX-801 yielded equivalent protection to the traditional percutaneous administration CHATHAM, N.J., July 10, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a fully integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the presentation of new findings on TNX-801 (recombinant horsepox, live virus vaccine) at the Vaccine Congress 2025 in Vienna on July 10, 2025, by Si
The previously disclosed and now published RESILIENT data show that once-nightly TNX-102 SL achieved statistically significant improvement in the primary endpoint of reducing fibromyalgia pain versus placebo, and was generally well tolerated These results confirm findings from the previously published RELIEF phase 3 trial, which also demonstrated a statistically significant reduction in fibromyalgia pain FDA target PDUFA date for TNX-102 SL is August 15, 2025 and, if approved, would be the first new drug for treating fibromyalgia in more than 15 years CHATHAM, N.J., July 09, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a clinical-stage biopharmaceutical co
Single dose vaccination with TNX-801 protects animals from a lethal challenge with monkeypox, the causative agent of mpox TNX-801 confers durable protection after a single dose TNX-801 is well tolerated in immunocompromised animals, without evidence of spreading to blood or tissues even at high doses CHATHAM, N.J., July 07, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Sina Bavari, PhD, Executive Vice President of Infectious Disease Research and Development at Tonix Pharmaceuticals, will present new da
Combination treatment of mTNX-1700 (mTFF2-MSA fusion protein) with anti-PD1 antibody was associated with increased survival and decreased metastases in animal models of gastric cancer relative to anti-PD1 treatment alone mTNX-1700 treatment was associated with activation of cancer-killing CD8+ T Cells and limiting neutrophil-mediated immune evasion TNX-1700 (hTFF2-HSA fusion protein) is in preclinical development for gastric and colorectal cancers CHATHAM, N.J., July 02, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, toda
CHATHAM, N.J., June 30, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated biotechnology company, today announced that it will be added to the broad-market Russell 3000® Index, with automatic inclusion in the small-cap Russell 2000® Index, after the open of U.S. equity markets today, June 30, 2025, as part of the 2025 Russell indexes reconstitution. The annual reconstitution of the Russell US indexes captures the 4,000 largest US stocks as of April 30, ranking them by total market capitalization. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attr
TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia: FDA PDUFA goal date of August 15, 2025 TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of reduction in fibromyalgia pain in two double-blind randomized placebo-controlled Phase 3 studies If approved by FDA, TNX-102 SL would become the first member of a new class of non-opioid analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years CHATHAM, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company) presented data
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Live Leadership Updates
Mr. Hunter brings more than 40 years of experience building and leading commercial organizations in the biopharmaceutical industry, including leadership roles at Validus Pharmaceuticals, Relialab and Novartis Led launch of Tonix Medicines, acquisition of migraine assets Zembrace® SymTouch® and Tosymra®, and recruitment of commercial leadership team Appointment strengthens commercial strategy and governance as Tonix prepares for potential launch of TNX-102 SL for fibromyalgia this year CHATHAM, N.J., June 13, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated biotechnology company with marketed products and a pipeline of
Mr. Hand brings more than 20 years of strategic legal and business leadership experience across multiple functions in the biopharmaceutical industry, including nearly a decade in senior executive positions at Celgene Served on Celgene's Executive Committee and played a key leadership role in the BMS transaction, the integration of Celgene into BMS, and the divestiture of Otezla® to Amgen Appointment marks a key addition as Tonix readies for the potential approval of TNX-102 SL for the management of fibromyalgia next quarter CHATHAM, N.J., May 14, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical compa
FDA PDUFA goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia; if approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years Announced positive topline results from Phase 1 study of TNX-1500, a next generation anti-CD40L mAb candidate in development for prevention of kidney transplant rejection and treatment of autoimmune disorders Cash and cash equivalents of $131.7 million reported as of March 31, 2025; Current cash sufficient to fund operations into the second quarter of 2026 CHATHAM, N.J., May 12, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated
August 15, 2025, is the FDA PDUFA goal date for TNX-102 SL for the management of fibromyalgia; If approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years Company expects to have sufficient cash to fund planned operations beyond the FDA PDUFA goal date and anticipated fourth quarter 2025 launch of TNX-102 SL for fibromyalgia; $98.8 million in cash as of December 31, 2024 Announced positive topline results from Phase 1 study of TNX-1500, a next generation anti-CD40L mAb candidate for prevention of kidney transplant rejection and treatment of autoimmune diseases Received government grant for potential mpox vaccine, TNX-801, which has demonst
Mr. Ainsworth brings over two decades of industry and market access experience to Tonix U.S. Food and Drug Administration (FDA) recently assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for U.S. marketing authorization of TNX-102 SL for the management of fibromyalgia CHATHAM, N.J., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the appointment of Gary Ainsworth as Vice President, Market Access, effective immediately. Mr. Ainsworth is an accomplished executive with leadershi
Tonix appoints two executives with decades of experience successfully launching and commercializing new CNS products Bradley Raudabaugh, MBA, joins as Vice President, Marketing, bringing over 25 years of marketing, sales and product planning experience to Tonix Errol Gould, Ph.D., joins Tonix as Vice President, Medical Affairs, with over 25 years of experience in R&D and medical affairs across a wide range of therapeutic areas, including fibromyalgia New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia submitted to FDA in October 2024; NDA acceptance expected December 2024; Fast Track designation previously granted by FDA; FDA decision on approval expected 2025 If
Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studies Granted Fast Track Designation by FDA in July 2024 for TNX-102 SL, a centrally-acting, non-opioid analgesic; Fibromyalgia is a common chronic pain condition that affects mostly women Expect FDA decision in December 2024 on TNX-102 SL NDA acceptance for review and 2025 PDUFA date; If FDA-approved in 2025, TNX-102 SL would be the first new drug for fibromyalgia in more than 15 years Presented new data on potential mpox vaccine, TNX-801, in September and October 2024, demonstrating tolerability in immunocompromised animals; Previously repo
Thomas brings more than 20 years of commercial and operations experience in the biopharmaceutical industry to Tonix Tonix is on track to submit an NDA for TNX-102 SL for fibromyalgia in October of 2024 CHATHAM, N.J., Sept. 10, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the appointment of Thomas (Tom) Englese as Executive Vice President of Commercial Operations, effective immediately. Mr. Englese brings significant leadership across several functions, including commercial operations, sales and marketing, and launching and mana
Interim Analysis of Registration-Enabling Phase 3 Fibromyalgia Trial of TNX-102 SL Expected Second Quarter 2023; Topline Data Expected Fourth Quarter 2023 Potentially Pivotal Phase 2 Trials of TNX-1900 in Chronic Migraine and TNX-601 ER in Depression Scheduled for Interim Analyses in Fourth Quarter 2023 Potentially Pivotal Phase 2 Fibromyalgia-Type Long COVID Study Enrolling Cash and Cash Equivalents Totaled Approximately $120.2 Million at December 31, 2022 CHATHAM, N.J., March 13, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and fu
CHATHAM, N.J., Feb. 23, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the appointment of R. Newcomb Stillwell to its Board of Directors, to be effective as of March 15, 2023. "We are pleased to welcome Newcomb to our Board of Directors," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. "Mr. Stillwell brings nearly four decades of experience in corporate law, having practiced exclusively at Ropes & Gray LLP, where he was the Co-Managing Partner of the Boston office. His extensive advisory experience on numerous transactions in the life science and health
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Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years Fibromyalgia is a chronic pain condition that affects more than 10 million adults in the U.S. who are mostly women Two Pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo; generally well tolerated Commercial availability of Tonmya is expected in the fourth quarter Company to host webcast and conference call on Monday August 18, 2025 at 8:30 AM ET CHATHAM, N.J., Aug. 15, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a fully-integrated biotechnology company, today announced that the U.S. Food and Drug Administratio
Strategic Acquisition Helps Build Tonix's Commercial Capabilities and Infrastructure Ahead of Potential Launch of TNX-102 SL for the Management of Fibromyalgia Acquisition of Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray), Indicated for the Treatment of Acute Migraine in Adults, Complements Tonix's Current Intranasal Clinical Development Program of TNX-1900 for Migraine Prevention CHATHAM, N.J., July 03, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix Pharmaceuticals or Tonix), a biopharmaceutical company, and its wholly-owned commercialization subsidiary Tonix Medicines, Inc. (Tonix Medicines), today announced it
Five Potentially Pivotal Phase 2 or 3 Studies for CNS Programs Expected to be in the Clinic by First Quarter 2023 Data from Planned Interim Analyses of TNX-102 SL in Phase 3 Fibromyalgia Study and Phase 2 Long COVID Study Expected Second Quarter 2023 Advanced Development Center in Dartmouth, Mass. and Infectious Disease Research and Development Facility in Frederick, Md. Operational Cash and Cash Equivalents Totaled Approximately $140 Million at September 30, 2022 CHATHAM, N.J., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the
The ADC is Expected to Accelerate Clinical-Scale Manufacturing of Live Virus Vaccines, Including Vaccines for Monkeypox, Smallpox and COVID-19 Internal Manufacturing Capabilities Expected to Support U.S. Pandemic Preparedness CHATHAM, N.J., June 16, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it will hold a ribbon-cutting ceremony at the Company's 45,000 square foot clinical-scale manufacturing facility in the New Bedford Business Park in North Dartmouth, Massachusetts on June 21, 2022 at 1:00 pm ET. The new facility houses Tonix's Advanced Development Center (ADC) for acce
Immunology and CNS Programs Entering the Clinic in 2022 for Organ Transplantation, Cocaine Intoxication, Fibromyalgia, PTSD, Migraine Headache and Binge Eating Disorder Covid-19 Programs Include Upcoming Phase 2 Trial in Long Covid, Results of First-in-Human T Cell Immunity Skin Test and New Versions of Our Live Virus Covid-19 Vaccine That Express Spike Proteins From the Omicron and BA.2 Variants Expansion of Internal Research and Development Capabilities Underway to Accelerate Infectious Disease Programs and Prepare for Future Pandemic Responses Orphan-Drug Designation Granted for TNX-2900 (Intranasal Potentiated Oxytocin) for Prader-Willi Syndrome Cash and Cash
NEW YORK, Feb. 28, 2022 (GLOBE NEWSWIRE) -- New to The Street TV, a nationally syndicated business show and FMW Media production, announces its Fox Business Network televised line-ups for tonight, Monday, February 28, 2022, 10:30 PM PT and for Tuesday night, March 01, 2022, 10:30 PM PT. Episode #312, airing tonight, Monday, February 28, 2022, 10:30 PM PT on the Fox Business Network with the following five (5) Companies and their businesses representatives: 1). Tonix Pharmaceuticals, Inc.'s (NASDAQ:TNXP) interview, Dr. Seth Lederman, MD, CEO.2). GlobeX Data, Ltd.'s (OTCQB:SWISF) (CSE:SWIS) (FRA: GDT) interview, Mr. Alain Ghiai, CEO.3). Rego Payments Architectures, Inc.'s. (OTCQB:RPMT) int
NEW YORK, Feb. 18, 2022 (GLOBE NEWSWIRE) -- FMW Media's New to The Street / Newsmax TV announces the broadcasting line-up of its national syndicated 1- hour TV show this Sunday, February 20, 2022, airing time 10-11 AM ET. New to The Street's 307th TV episode line-up, features eight (8) interviews of the following Companies and their businesses representatives: 1). GOLD – Glint Pay's interview, Mr. Jason Cozens, CEO. 2). Cryptocurrency – Glow Token LLC's (CRYPTO: GLOWV2) ($GLOWV2) interviews, Mr. Bryan Lawrence, CEO & Co-Founder, and Mr. Adam Beier, CFO & Co-Founder. 3). Cryptocurrency – Vulcan Forged's (CRY
Expansion of Internal Research and Development Capabilities Underway to Accelerate Infectious Disease Programs and Prepare for Future Pandemic Responses COVID-19 Pipeline Progressing with First-in-Human Trial of TNX-2100 Novel Skin Test for SARS-CoV-2 Functional T cell Immunity Expected to Start this Quarter Phase 2 Trial of TNX-1300 in Cocaine Intoxication Expected to Start this Quarter At September 30, 2021, Cash and Cash Equivalents Totaled Approximately $183 Million CHATHAM, N.J., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the third q
R&D Center is Expected to Accelerate Internal Discovery and Development of Vaccines and Antiviral Drugs Against COVID-19, its Variants and Other Infectious Diseases Domestic R&D Capability for Vaccines and Antivirals Intended to Support U.S. Pandemic Preparedness CHATHAM, N.J., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced it has completed the acquisition of its new research and development center (RDC) located in Frederick, Md. The approximately 48,000 square foot facility will support Tonix's expanding infectious disease pipeline, including: TNX-1800 - a live virus vacci
Central Nervous System Pipeline Progressing with Two Phase 2 Studies (TNX-1300 and TNX-1900) and One Phase 3 Study (TNX-102 SL) Expected to Start This Year COVID-19 Pipeline Progressing with First-in-Human Trial of TNX-2100, a Novel in vivo Skin Test for COVID-19 T cell Immunity, Expected to Start This Year New Advanced Development Center, Currently Under Construction, and Planned Acquisition of Infectious Disease R&D Facility Will Expand Internal R&D and Manufacturing Capabilities for Vaccines and Antiviral Therapeutics, With Initial Focus on COVID-19 At June 30, 2021, Cash and Cash Equivalents Totaled Approximately $166 Million CHATHAM, N.J., Aug. 09, 2021 (GLOBE NEWSWIRE) -- Tonix