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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CHATHAM, N.J., April 16, 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 the Company will deliver an oral presentation and lead a panel discussion at the World Vaccine Congress Washington 2025, which will be held in Washington, D.C., April 22-24, 2025. A copy of the Company's presentation will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the World Vaccine Congress website here. Presentati
Agreement includes the use of Tonix's TNX-1500, as part of an immunomodulatory regimen to reduce rejection of Makana's genetically engineered pig organs in xenotransplantation Establishes framework for Makana's kidney, heart and islet cell programs to utilize TNX-1500 for preclinical studies in support of regulatory filings for potential use in human recipients CHATHAM, N.J. and MIAMI, April 09, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), ("Tonix") a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, and Makana Therapeutics, Inc. ("Makana"), a global leader in the field of xenotransplantation, t
TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of reduction in fibromyalgia pain in two pivotal double-blind randomized Phase 3 studies FDA Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia If approved by FDA, it 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., April 07, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals
CHATHAM, N.J., April 02, 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 that Seth Lederman M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the 2025 Jones Trading Healthcare and Innovation Conference on Wednesday, April, 9, 2025, at 10:00 a.m. PT (1:00 p.m. ET) in Las Vegas, Nev. Investors interested in arranging a meeting with the Company's management during the conference should contact the Jones Trading conference coordinator. A live webcast of the presentation can be found under the IR Events tab of the To
CHATHAM, N.J., April 01, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a biopharmaceutical company with a portfolio of marketed products and a pipeline of development candidates, today announced the launch of TONIX ONE™, a fully-integrated digital platform designed to help patients better understand and manage their migraine condition. Through a series of strategic partnerships with UpScript Telemedicine, ProModRx, Blink Health and a leading mobile application specializing in disease tracking, reporting and symptom management, Tonix is streamlining the migraine patient journey into a unified digital platform. Please visit www.tonixone.com for details. "We
CHATHAM, N.J., March 27, 2025 (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 that Seth Lederman, M.D., Chief Executive Officer, will present a poster at the AAPM 2025 Annual Meeting, PainConnect, in Austin, Texas on April 5, 2025, at 11:45 a.m. CT. The meeting will take place from April 3-6, 2025. A copy of the Company's poster will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the conference website. Tonix Pharma
On track for August 15, 2025 FDA PDUFA goal date TNX-102 SL is a non-opioid analgesic; if approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years Commercial planning for TNX-102 SL underway for launch in the fourth quarter of 2025 CHATHAM, N.J., March 24, 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 the U.S. Food and Drug Administration (FDA) will not require an Advisory Committee meeting to discuss the Company's New Drug Application (NDA) for TNX-102 SL for th
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
NEW YORK, March 14, 2025 (GLOBE NEWSWIRE) -- Virtual Investor Conferences, the leading proprietary investor conference series, today announced the presentations from the Life Science Virtual Investor Forum, held March 13th are now available for online viewing. REGISTER NOW AT: https://bit.ly/3DIWqav The company presentations will be available 24/7 for 90 days. Investors, advisors, and analysts may download investor materials from the company's resource section. Select companies are accepting 1x1 management meeting requests through March 18th. To facilitate investor relations scheduling and to view a complete calend
CHATHAM, N.J., March 13, 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 Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the 2025 BIO-Europe Spring Convention being held March 17-19, 2025, in Milan, Italy. The Company's presentation will take place on Monday, March 17, 2025, at 2:00 p.m. CET in the Exhibit Hall Stage Room of the Allianz MiCo Central Building. Dr. Lederman's presentation will focus on TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the management o
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
CHATHAM, N.J., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the appointment of Zeil Rosenberg, M.D., M.P.H. as its new Executive Vice President, Medical. In this role, Dr. Rosenberg will be responsible for leading Tonix's clinical development efforts for vaccines and antivirals. Dr. Rosenberg will be based in the Company's Chatham, N.J. headquarters, and as part of his role will oversee the clinical development of Tonix's vaccine for smallpox and monkeypox, TNX-801, the vaccine for COVID-19, TNX-1850, and the antiviral anti-SARS-CoV-2 spike protein monoclonal antibodie
Phase 1 Study of TNX-801, a Vaccine in Development for the Prevention of Monkeypox and Smallpox, Expected to Initiate in First Half 2023 in Kenya; the U.S. has Declared Monkeypox a Public Health Emergency U.S. National Institute of Drug Abuse (NIDA) Grant Awarded for the Development of TNX-1300 for Cocaine Intoxication; Phase 2 Study of TNX-1300 Expected to Initiate in Fourth Quarter 2022 Advanced Development Center in Dartmouth, Mass. is Open and Expected to Imminently Conduct Process Development and Clinical Trial Manufacturing of Live-Virus Vaccines Cash and Cash Equivalents Totaled Approximately $145 Million at June 30, 2022 CHATHAM, N.J., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Tonix
CHATHAM, N.J., July 25, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the appointment of Sina Bavari, Ph.D. as its new Executive Vice President, Infectious Disease Research and Development. In this role, Dr. Bavari will be responsible for leading Tonix's development of its growing infectious disease pipeline and will serve as a key member of the Company's executive leadership team. Dr. Bavari will be based in Frederick, Md. and, as part of his role, will oversee scientific development at Tonix's Infectious Disease R&D Center located there. "We are delighted that Dr. Bavari has
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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
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
Announced Positive Efficacy Data from Animal Studies of COVID-19 Vaccine Candidate, TNX-1800 Interim Analysis of Second Confirmatory Phase 3 Study in Fibromyalgia Expected in Third Quarter 2021 Deep Pipeline Progressing with Three Central Nervous System (CNS) Programs Expected to Enter Phase 2 Trials This Year At March 31, 2021, Cash and Cash Equivalents Totaled Approximately $164 Million CHATHAM, N.J., May 10, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2021 and provided an overview of recent operational highlights.