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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NEW YORK, March 13, 2026 (GLOBE NEWSWIRE) -- Virtual Investor Conferences, the leading proprietary investor conference series, today announced that presentations from the Life Sciences Virtual Investor Forum, held March 11th – 12th, are now available for on-demand viewing. The forum featured CEO chats and company presentations from leadership teams representing innovative companies across the biotechnology, medical device, and pharmaceutical sectors, offering investors insights into emerging technologies, strategic initiatives, and growth opportunities within the life sciences industry. REGISTER AND VIEW PRESENTATIONS HERE The presentations will be available 24/7 for 90 days. Investors,
TONMYA™ (cyclobenzaprine HCl sublingual tablets) launched November 17, 2025, for the treatment of fibromyalgia; through February 27, 2026, more than 1,500 healthcare providers have prescribed TONMYA to patients, approximately 2,500 patients have initiated treatment with TONMYA, and cumulative prescriptions totaled approximately 4,200 Expect to initiate U.S. field study in 2027 for TNX-4800 for seasonal prevention of Lyme disease pending FDA clearance Completed $20.0 million registered direct offering with Point72 on December 29, 2025 Approximately $207.6 million in cash and cash equivalents as of December 31, 2025 BERKELEY HEIGHTS, N.J., March 12, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmac
NEW YORK, March 10, 2026 (GLOBE NEWSWIRE) -- Virtual Investor Conferences, the leading proprietary investor conference series, today announced the agenda for the Life Sciences Virtual Investor Forum, taking place March 11–12, 2026. Individual investors, institutional investors, advisors, and analysts are invited to attend. REGISTER HERE Investors are encouraged to pre-register and run the online system check to expedite participation and receive event updates. Participation is free, and attendees may watch live company presentations and schedule one-on-one meetings with management teams. Schedule 1x1 meetings here "We are delighted to highlight today's innovators from the Life Science
Company launched TONMYA, approved by the FDA as a treatment for fibromyalgia, in November 2025 In post hoc analysis of the pivotal RESILIENT study, TONMYA produced rapid pain relief as early as Day 2 of treatment, with durable pain reduction and significant improvements in all key secondary endpoints as compared to placebo In pooled post hoc analysis of the pivotal RELIEF and RELISIENT studies, TONMYA showed favorable benefit-risk profile using number needed to treat, number needed to harm, and likelihood to be helped or harmed BERKELEY HEIGHTS, N.J., March 10, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, com
TONMYA (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, was commercially launched in November 2025 Treatment with TONMYA provided statistically significant pain reduction in two Phase 3 trials and was generally well tolerated BERKELEY HEIGHTS, N.J., March 09, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, presented data on TONMYATM (cyclobenzaprine HCl sublingual tablets), at the 2026 American Academy of Pain Medicine (AAPM) PainConnect Annual Meeting, in Salt Lake City, Utah. "The data presented at the AAPM PainConnect Annual Meeting support
Commercially launched in the U.S. in November 2025, TONMYA (cyclobenzaprine HCl sublingual tablets) for long-term daily dosing at bedtime is the first new FDA-approved treatment for fibromyalgia in adults in more than 15 years The sublingual TONMYA tablet containing a basifying agent achieved the design objectives of rapid transmucosal absorption and bypassing first-pass liver metabolism TONMYA was designed to decrease production of the active metabolite norcyclobenzaprine, which is believed to improve the durability of analgesic response in fibromyalgia relative to the transient (~1 month) effects of oral, swallowed cyclobenzaprine BERKELEY HEIGHTS, N.J., March 05, 2026 (GLOBE NEWSWIRE
CHATHAM, N.J., March 03, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully-integrated, commercial biotechnology company, announced today that a poster on Tonmya™ (cyclobenzaprine HCl sublingual tablets), which was investigated as TNX-102 SL, will be presented at the 2026 American Academy of Pain Medicine (AAPM) PainConnect Annual Meeting, being held March 5–8, 2026, in Salt Lake City, Utah. A copy of the Company's presentation will be available under the Presentations tab of the Tonix website at https://ir.tonixpharma.com/presentations. Poster Presentation DetailsTitle: Treatment with TNX-102 SL Produces Clinically Meaningful I
BERKELEY HEIGHTS, N.J., March 03, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, today announced that it has received approval from Nasdaq to transfer the listing of its common stock from the Nasdaq Capital Market to the Nasdaq Global Select Market. Trading on the Nasdaq Global Select Market is expected to commence at the open of market on March 3, 2026, under the Company's existing ticker symbol "TNXP." The uplisting to the Nasdaq Global Select Market reflects the Company's compliance with the Nasdaq Global Select Market's higher financial and corporate governance standards. The
BERKELEY HEIGHTS, N.J., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, today announced that the management team will participate in two upcoming investor conferences in March 2026: TD Cowen 46th Annual Healthcare ConferenceCompany PresentationPresenter: Seth Lederman, M.D., President and Chief Executive Officer of Tonix PharmaceuticalsDate: Wednesday March 4, 2026Place: Boston Marriott Copley PlaceTime: 11:10 AM – 11:40 AM ETRoom: MIT, 3rd Floor Barclays 28th Annual Healthcare Conference Company ParticipationManagement will be available for 1x1 meetings, March 10 - 12, a
TONMYA demonstrated significant reduction in fibromyalgia pain compared with placebo in the Phase 3 RESILIENT study Unique sublingual formulation designed for bedtime dosing bypasses first-pass metabolism, optimizing parent-drug exposure during sleep and decreasing levels of the persistent active metabolite Treatment was well tolerated with minimal effects on weight or blood pressure CHATHAM, N.J., Jan. 30, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, presented data on TONMYA™, which was investigated as TNX-102 SL, at the 2026 Non-Opioid Pain Therapeutics Summit, on January 29
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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
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
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CHATHAM, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated commercial-stage biotechnology company today announced the appointment of Irina Ishak as General Counsel, effective December 8, 2025. Ms. Ishak will lead Tonix's legal, corporate governance, and compliance functions. "Irina is a highly accomplished corporate and commercial attorney whose experience spans public and private life sciences companies, as well as advising life sciences investors," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. "Her deep background in complex transactions, public company matters, and governa
Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia set to launch in November Tonmya is the first new FDA-approved medicine for fibromyalgia in more than 15 years Cash and cash equivalents of $190.1 million reported as of September 30, 2025; current cash runway expected to fund operations into the first quarter of 2027 CHATHAM, N.J., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully-integrated commercial biotechnology company today announced financial results for the third quarter ended September 30, 2025, and provided an overview of recent operational highlights. "Following U.S. Food a
Mr. Kamath brings more than 25 years of market access, pricing, and commercial operations experience to Tonix On August 15, 2025, the U.S. Food and Drug Administration approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, the first new fibromyalgia therapy in more than 15 years US Launch of Tonmya expected in the fourth quarter of 2025 CHATHAM, N.J., Sept. 30, 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 development candidates, today announced the appointment of Ganesh Kamath as Head of Market Access
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