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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

Clade I, the culprit in the current 2025 version of global epidemic mpox, is highly transmissible and is spreading within families and among children, whereas the 2022 Clade II mpox - still spreading - infects mostly gay men CHATHAM, NJ / ACCESS Newswire / March 20, 2025 / This post was written and published as a collaboration... Read More

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... Read More

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.... Read More

This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their... Read More

CHATHAM, N.J., March 11, 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 Zacks SCR Life Sciences Virtual Investor Forum on Thursday, March 13, 2025, at 3:30 p.m. ET.... Read More

The World Health Organization (WHO) recently reaffirmed the spread of new clade Ib Mpox a public health emergency of international concern (PHEIC): second Mpox-related WHO PHEIC declaration in two years Clade Ib Mpox cases detected in several countries in Central and Eastern Africa as well as China, Thailand, Singapore, India, England, parts of Europe and the Middle East, Canada and the United States Tolerability of TNX‐801... Read More

CHATHAM, N.J., March 05, 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, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the 2025 Virtual Investor Summit on Tuesday, March 11, 2025, at 10:30 a.m. ET. Investors... Read More

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 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... Read More

Company had $98.8 million in cash as of December 31, 2024; existing cash expected to fund planned operations into the first quarter of 2026 Company is debt-free after repaying mortgage on facilities TNX-102 SL fibromyalgia FDA PDUFA goal date is August 15, 2025 $10.1 million in net sales from migraine products in 2024 CHATHAM, N.J., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix... Read More

Results from the Phase 1 single ascending dose study support proceeding to develop a Phase 2 trial for the prevention of kidney transplant rejection TNX-1500 blocked the primary and secondary antibody responses to a test antigen at the 10 mg/kg and 30 mg/kg i.v. doses TNX-1500 showed mean half-life of 34-38 days for the 10 mg/kg and 30 mg/kg doses supporting monthly dosing for future efficacy trials TNX-1500 was generally... Read More

CHATHAM, N.J., Feb. 05, 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., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at the BIO CEO & Investor Conference on February 10, 2025, at 1:45 p.m. ET in New York City.... Read More

Ms. Fogarty has served at Tonix since 2016, most recently as Executive Vice President, Product Development Tonix is Preparing for Potential Launch of TNX-102 SL for the management of fibromyalgia with U.S. FDA PDUFA goal date of August 15, 2025 CHATHAM, N.J., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed... Read More

CHATHAM, N.J., Feb. 03, 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 it will effect a 1-for-100 reverse stock split of its outstanding common stock. The reverse stock split will be effective for trading purposes as of the commencement of... Read More

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... Read More

CHATHAM, N.J., Jan. 07, 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, announced today that Tonix management will present and host investor meetings at the following January investor conferences: 8 th Annual Neuroscience Innovation Forum by Sachs Associates Company Presentation... Read More

Tonix received FDA’s Day 74 Letter granting TNX-102 SL a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025 TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA Fibromyalgia affects more than 10 million adults in the U.S., who are mostly women TNX-102 SL has the potential to be the first member of a new class of analgesic drugs for fibromyalgia and first new drug for... Read More

FDA is expected to assign a Prescription Drug User Fee Act (PDUFA) target action date and announce whether Priority Review has been granted in the Day 74 Letter TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA Fibromyalgia affects more than 10 million adults in the U.S. who are mostly women TNX-102 SL has the potential to be the first member of a new class of analgesic drugs for... Read More

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... Read More

CHATHAM, N.J., Nov. 26, 2024 (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, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present and conduct investor meetings at NobleCon20, Noble Capital Markets’ Twentieth Annual Emerging... Read More

CHATHAM, N.J., Nov. 18, 2024 (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, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the Winter 2024 Investor Summit Virtual on Thursday, November 21, 2024, at 10:00 a.m. ET.... Read More

Poster presentation highlighted results from confirmatory Phase 3 RESILIENT study of TNX-102 SL (sublingual cyclobenzaprine HCl) treatment demonstrating statistically significant improvement in primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality New Drug Application (NDA) submitted to FDA in October 2024; Fast Track designation previously granted by FDA; FDA... Read More

CHATHAM, N.J., Nov. 13, 2024 (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 deliver a poster presentation at the ACR Convergence 2024 Annual Meeting, which will be held in... Read More

The World Health Organization (WHO) declared the spread of new Clade Ib Mpox a public health emergency of international concern (PHEIC): Second Mpox-related WHO PHEIC declaration in two years Clade Ib Mpox cases detected in 16 African countries and outside of Africa, in Sweden, Thailand, Singapore, India, Germany and England Single-dose mpox vaccines with durable protection may be required to address global health emergency... Read More

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... Read More

Proposed clinical study in Kenya intended to test the safety, tolerability, and immunogenicity of TNX-801, a vaccine being developed to prevent mpox (formerly called monkeypox) The World Health Organization (WHO) declared mpox a public health emergency of international concern (PHEIC) 1-4 : cases of the new Clade Ib mpox detected in Sweden, Thailand, Singapore, India, Germany and England In preclinical data, TNX-801, Tonix’s... Read More

New data show tolerability and no evidence of spreading to blood or tissues even at high doses of Tonix’s attenuated live-virus, minimally replicating vaccine candidate TNX-801 in immunocompromised animals TNX-801, has characteristics that align closely with the World Health Organization’s (WHO) preferred target product profile (TPP) criteria for mpox vaccines WHO-declared public health emergency of international concern... Read More

CHATHAM, N.J., Oct. 29, 2024 (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, announced today that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at BIO-Europe ® , being held November 4-6, 2024, in Stockholm, Sweden. The presentation... Read More

CHATHAM, N.J., Oct. 25, 2024 (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, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the ThinkEquity Conference on Wednesday, October 30, 2024, at 9:30 a.m. ET, and host... Read More

CHATHAM, N.J., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Zeil Rosenberg, M.D., M.P.H., Executive Vice President, Medical, Tonix Pharmaceuticals, will deliver an oral presentation at the World Vaccine Congress Europe, which will be... Read More

CHATHAM, N.J., Oct. 17, 2024 (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, received its first payment from the Defense Threat Reduction Agency (DTRA), an agency within the U.S. Department of Defense (DoD), to develop small molecule broad-spectrum antiviral agents for... Read More

NDA based on two Phase 3 studies of TNX-102 SL in fibromyalgia with statistically significant results on the primary endpoint of reducing widespread pain; generally well tolerated TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA Fibromyalgia affects more than 10 million adults in the U.S. who are mostly women If approved by FDA, TNX-102 SL would be the first member of a new class... Read More

AI (Artificial Intelligence) and ML (Machine Learning) drug discovery collaboration will accelerate the development of small molecules as orally available host-targeted broad-spectrum medical countermeasures Host-directed antiviral drugs have the potential to enhance the immune response to viruses from a range of viral families Tonix was awarded a contract with the U.S. Department of Defense for up to $34 million for the... Read More

CHATHAM, N.J., Sept. 30, 2024 (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, participated in the “Endpoints” panel at the RECOVER Treating Long COVID (TLC) – Navigating the... Read More

New patent expected to provide market exclusivity into 2036 Zembrace ® SymTouch ® (sumatriptan succinate injection) 10mg is indicated for the acute treatment of migraine in adults CHATHAM, N.J., Sept. 27, 2024 (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... Read More

Presentations highlighted the proprietary formulation technology and pharmacokinetic properties of TNX-102 SL (sublingual cyclobenzaprine HCl) Composition and methods patents based on the eutectic formulation of TNX-102 SL are expected to provide market exclusivity until at least 2034 in the U.S., E.U., Japan, China and other jurisdictions U.S. FDA New Drug Application (NDA) submission on track for October 2024; Fast Track... Read More

New patent expected to expire in 2030 Tosymra ® (sumatriptan nasal spray) 10mg is indicated and marketed for the acute treatment of migraine in adults CHATHAM, N.J., Sept. 19, 2024 (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 United States... Read More

This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be... Read More

The World Health Organization (WHO) released its preferred target product profile (TPP) criteria for mpox vaccines at its Mpox Research and Innovation Scientific Conference held August 29-30 TNX-801, Tonix’s attenuated live-virus vaccine candidate, has characteristics that align closely with WHO’s TPP On August 14, 2024, the WHO determined that the upsurge of mpox in a growing number of countries in Africa constitutes a... Read More

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... Read More

TNX-801 vaccination demonstrated efficacy in protecting animals from lethal challenge with clade I monkeypox and is in development as an mpox vaccine New data show improved tolerability in immunocompromised animals and no evidence of spreading to blood or tissues even at high doses Tonix’s synthetic horsepox vaccine platform has been selected by NIH’s Project NextGen for clinical testing CHATHAM, N.J., Sept. 09, 2024 (GLOBE... Read More

Gastroparesis slows the ability of the stomach to empty into the small intestine and thereby can delay absorption of oral medications into the bloodstream Non-oral medications including nasal and injectables can bypass the digestive system providing better absorption and faster relief CHATHAM, N.J., Sept. 06, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a... Read More

This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be... Read More

Investigator-initiated Phase 2 trial to evaluate TNX-102 SL’s potential to reduce severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) expected to begin third quarter 2024 Currently, no medication approved at or near point-of-care to treat patients suffering from traumatic events and support their long-term health CHATHAM, N.J., Aug. 29, 2024 (GLOBE... Read More

Oral presentation highlighted results from confirmatory Phase 3 RESILIENT study of TNX-102 SL (sublingual cyclobenzaprine HCl) treatment demonstrating statistically significant improvement in primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality NDA submission on track for second half 2024; Fast Track designation granted by FDA; FDA decision expected 2025 TNX-102 SL... Read More

World Health Organization declared spread of mpox in multiple African countries a public health emergency of international concern (PHEIC) for the second time in two years Worldwide availability and affordability of single-dose mpox vaccine with durable protection will be required to address global health emergency The newest Clade 1 strain represents a new global threat with mortality up to 10% Bilthoven Biologicals to... Read More

This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be... Read More

Oral presentation highlights TNX-102 SL (sublingual cyclobenzaprine HCl) treatment in Phase 3 RESILIENT study demonstrating statistically significant improvement in fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality Posters highlighting other TNX-102 SL programs in clinical development, including acute stress disorder Poster demonstrating automated high-throughput assay enabling... Read More

CATALYST is a Phase 2 single-blind, placebo-controlled, proof-of-concept study in patients presenting to the emergency department More than 27,569 individuals in the U.S. died from drug overdose deaths involving cocaine in 2022; there is currently no FDA-approved product for cocaine intoxication Topline results are expected in the first half of 2025 CHATHAM, N.J., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals... Read More

On track to submit NDA in second half 2024 for TNX-102 SL for fibromyalgia; completed successful pre-NDA meetings with FDA in second quarter 2024 FDA granted Fast Track designation for TNX-102 SL for fibromyalgia Commercial planning continues for U.S. launch of TNX-102 SL, a potential new first-line, centrally-acting, non-opioid analgesic for the management of fibromyalgia U.S. Department of Defense contract awarded for up... Read More

World Health Organization (WHO) has declared spread of mpox in multiple African countries a public health emergency of international concern (PHEIC) 1 Tonix’s live virus vaccine candidate, TNX-801, is designed to provide long-term protection from mpox and smallpox with one dose TNX-801 vaccination demonstrated efficacy in protecting animals from lethal challenge with intratracheal monkeypox virus Clade II mpox is now endemic... Read More

CHATHAM, N.J., Aug. 13, 2024 (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, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at the Summer 2024 Virtual Investor Summit on Tuesday, August 20, 2024, at... Read More

Bedtime TNX-102 SL (sublingual cyclobenzaprine HCl) treatment in the Phase 3 RESILIENT study resulted in statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality Post hoc analyses highlight the strong correlations between improvements in nociplastic pain and sleep quality Nociplastic pain originates from altered pain... Read More

High-throughput, high-content imaging-based assay developed to screen convalescent sera for neutralizing antibodies to SARS-CoV-2 variants Study highlights Tonix’s internal R&D capabilities in infectious disease that include a COVID-19 vaccine selected by NIH for Project NextGen and a host-directed anti-viral program awarded a DoD/DTRA contract for up to $34 million CHATHAM, N.J., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Tonix... Read More

Fibromyalgia is a “diagnosable condition” in people suffering from Long COVID according to NASEM 1 Diagnosing fibromyalgia in Long COVID patients is expected to expand the potential addressable market for Tonmya relative to pre-COVID-19 pandemic estimates 2 Tonmya is a potential new first-line non-opioid analgesic under development for the management of fibromyalgia with Fast Track designation: NDA submission target is... Read More

Presentation to highlight statistically significant Phase 3 results of Tonmya™ for the management of fibromyalgia, including improvement in pain and sleep quality Tonix granted FDA Fast Track Designation for Tonmya™; NDA submission on track for the second half of 2024 CHATHAM, N.J., July 30, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated... Read More

Fast Track is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need Fast Track designation for Tonmya recognizes fibromyalgia as a serious condition impacting more than 10 million U.S. adults NDA submission on track for second half 2024 Tonmya has the potential to be the first new drug for treating fibromyalgia in more than 15 years CHATHAM, N.J., July 25, 2024... Read More

CHATHAM, NJ / ACCESSWIRE / July 24, 2024 / From anthrax to the plague, biological warfare is a real threat to U.S. forces and civilians, so much so the Pentagon budgeted about $2 billion for the country's biological defense for the coming fiscal year. It's also why the U.S. Department of Defense is seeking broad-spectrum antiviral drugs and teaming up with the biotech companies developing them. That's the case with Tonix... Read More

CHATHAM, NJ / ACCESSWIRE / July 17, 2024 / With the completion of its final pre-NDA meeting with the FDA, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced it is filing an NDA submission in 2H 2024 and laying plans for the commercial launch of Tonmya™* for the management of fibromyalgia, assuming approval by the FDA in 2H 2025. The fibromyalgia market has not seen a new FDA-approved drug in over 15 years. And now... Read More

CHATHAM, N.J., July 10, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced the closing of its public offering of 3,393,600 shares of its common stock and pre-funded warrants to purchase up to 3,703,140 shares of common stock in a public offering at an offering price of $0.57 per share of common stock and $0.569... Read More

CHATHAM, N.J., July 09, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced it has entered into a placement agency agreement for the purchase and sale of 7,096,740 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.57 per share (or $0.569 per pre-funded warrant in lieu... Read More

CHATHAM, N.J., July 08, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof). All of the securities to be sold in the offering are to be offered by Tonix. The offering is subject to market conditions, and there... Read More

Tonmya is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia Approximately 10 million adults in the U.S. are affected by fibromyalgia, predominantly women NDA submission target confirmed for second half 2024, with potential for FDA approval in second half 2025 CHATHAM, N.J., July 08, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the... Read More

CHATHAM, N.J., July 01, 2024 (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 it has been awarded an Other Transaction Agreement (OTA) with a potential for up to $34 million over five years by the Defense Threat Reduction Agency (DTRA), an agency within... Read More

CHATHAM, N.J., June 28, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced the closing of its public offering of 2,833,900 shares of its common stock and pre-funded warrants to purchase up to 4,228,158 shares of common stock in a public offering at an offering price of $0.57 per share of common stock and $0.569... Read More

CHATHAM, N.J., June 27, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced it has entered into a placement agency agreement for the purchase and sale of approximately 7,060,918 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.57 per share (or $0.569 per pre-funded... Read More

CHATHAM, N.J., June 26, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof). All of the securities to be sold in the offering are to be offered by Tonix. The offering is subject to market conditions, and there... Read More

CHATHAM, N.J., June 26, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company, today announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. On June 26, 2024, Tonix received a letter from The Nasdaq Stock Market LLC stating that because Tonix’s shares had a... Read More

Tonix’s live virus vaccine TNX-801 is designed to provide long-term protection from mpox and smallpox with one dose TNX-801 vaccination demonstrated efficacy in protecting animals from lethal challenge with intratracheal monkeypox Clade II mpox is now endemic in the U.S. with >30,000 cases reported since May 2022 1 and Clade I mpox is endemic in the Democratic Republic of the Congo 2 Tonix’s vaccine platform has been... Read More

Company aligned with FDA on key CMC topics Tonix also has completed the second and final pre-New Drug Application (NDA) meeting and discussed nonclinical, clinical pharmacology and clinical matters with the FDA, formal minutes pending On track to submit NDA to the FDA in the second half of 2024 CHATHAM, N.J., June 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a... Read More

Gap in non-oral prescriptions relative to AHS guidelines represents an opportunity to increase awareness of Tonix’s two FDA-approved non-oral treatments for acute migraine Zembrace ® SymTouch ® (sumatriptan injection) and Tosymra ® (sumatriptan nasal spray) are indicated for the treatment of acute migraine in adults CHATHAM, N.J., June 18, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or... Read More

Treatment with Tonmya™ (TNX-102 SL, sublingual cyclobenzaprine HCl) in Phase 3 RESILIENT study significantly reduced daily pain and demonstrated broad fibromyalgia symptom improvement, as demonstrated by significant improvement on the primary pain endpoint and on all six key secondary endpoints RESILIENT was the second Phase 3 study to reach statistical significance on the primary endpoint New Drug Application (NDA)... Read More

CHATHAM, N.J., June 13, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced the closing of its public offering of 1,199,448 shares of its common stock and pre-funded warrants to purchase up to 2,568,110 shares of common stock in a public offering at an offering price of $1.065 per share of common stock and $1.064... Read More

CHATHAM, N.J., June 12, 2024 (GLOBE NEWSWIRE) - - Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced it has entered into a placement agency agreement for the purchase and sale of 3,753,558 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $1.065 per share (or $1.064 per pre-funded warrant in... Read More

CHATHAM, N.J., June 11, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof). All of the securities to be sold in the offering are to be offered by Tonix. The offering is subject to market conditions, and there... Read More

CHATHAM, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it will effect a 1-for-32 reverse stock split of its outstanding common stock. The reverse stock split will be effective for trading purposes as of the commencement of trading... Read More

TNX-1500 displays potential as a monotherapy or combination therapy to prevent rejection in organ transplantation in allograft and xenograft animal models Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital Transplantation is also believed to be a model for treating autoimmunity CHATHAM, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:... Read More

Presentation to highlight statistically significant Phase 3 results of Tonmya™ (TNX-102 SL) for the management of fibromyalgia New Drug Application (NDA) submission to the FDA on track for the second half of 2024 CHATHAM, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of... Read More

Tonmya treatment was associated with improvement in depressive symptoms as measured by the Beck Depression Inventory-II In addition, post-hoc analyses showed improvement in depression, anxiety, memory and energy items on the Fibromyalgia Impact Questionnaire-Revised New Drug Application (NDA) submission to the FDA on track for the second half of 2024 CHATHAM, N.J., June 03, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals... Read More

In the Phase 2 PREVAIL trial in fibromyalgia-type Long COVID, bedtime TNX-102 SL resulted in a signal in fatigue, sleep and cognitive function Phase 2, investigator-initiated OASIS trial is designed to examine the safety and efficacy of TNX-102 SL in treating Acute Stress Disorder (ASD) after motor vehicle collision First patient in OASIS expected to enroll in second quarter 2024 CHATHAM, N.J., May 30, 2024 (GLOBE NEWSWIRE)... Read More

CHATHAM, N.J., May 29, 2024 (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 two oral presentations and a poster presentation at the American Transplant Congress 2024, being held June 1-5, 2024 at the Pennsylvania Convention Center, Philadelphia, Pa.... Read More

Presentation to highlight statistically significant Phase 3 results of Tonmya™ for the management of fibromyalgia New Drug Application (NDA) submission to the FDA on track for the second half of 2024 CHATHAM, N.J., May 28, 2024 (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... Read More

Oral Presentation of Tonmya™ (TNX-102 SL) for Fibromyalgia; NDA preparation in progress Posters Highlighting Other TNX-102 SL Programs In Clinical Development; Long COVID and Acute Stress Disorder CHATHAM, N.J., May 22, 2024 (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... Read More

Tonmya is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia, supported by statistically significant results from two Phase 3 trials Primary physician research found high level of interest in Tonmya as a potential new treatment option for fibromyalgia Significant dissatisfaction reported with drugs currently approved by FDA for the treatment of fibromyalgia Analysis of claims... Read More

CHATHAM, N.J., May 15, 2024 (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, announced today that Seth Lederman, M.D., Chief Executive Officer, will participate virtually in a fireside chat at A.G.P.’s Healthcare Company Showcase on Tuesday, May 21, 2024, at 9:00 a.m. ET.... Read More

On track to submit NDA in the second half of 2024 for Tonmya™ for fibromyalgia; pre-NDA meeting with FDA scheduled for second quarter 2024 Commercial planning continues for U.S. launch of Tonmya, a potential new first-line, centrally-acting, non-opioid analgesic for the management of fibromyalgia CHATHAM, N.J., May 13, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a... Read More

CHATHAM, N.J., April 24, 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 that Seth Lederman, M.D., Chief Executive Officer, will present at the Planet MicroCap Showcase in Las Vegas, Nev. on May 1, 2024, at 8:00 a.m. PT (11:00 a.m. ET). The presentation will include... Read More

Positive results from confirmatory Phase 3 RESILIENT study reported in December 2023 position Tonmya™ for fibromyalgia for NDA submission second half of 2024; pre-NDA meeting with FDA scheduled for second quarter 2024 Commercial planning underway, including go-to-market, supply chain and manufacturing strategies, for U.S. launch of Tonmya, a potential new first-line, centrally-acting, non-opioid analgesic for the management... Read More

CHATHAM, N.J., March 28, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced it has entered into a securities purchase agreement with existing healthcare focused institutional investors of the Company for the purchase and sale of 14,666,666 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to... Read More

TNX-2900 is a proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and eating Prader Willi syndrome is the most common genetic cause of life-threatening childhood obesity CHATHAM, N.J., March 25, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a... Read More

Four Phase 2 investigator-initiated studies of TNX-1900 (intranasal potentiated oxytocin) are ongoing for pediatric obesity, binge eating disorder, bone health in autism and social anxiety disorder TNX-2900 (intranasal potentiated oxytocin) is being developed under an IND as a treatment for Prader-Willi Syndrome, an Orphan Disease characterized by excessive eating TNX-1900 and TNX-2900 may serve as novel neuroendocrine... Read More

Tonmya™ is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia, supported by positive results from two Phase 3 studies New Drug Application (NDA) submission to the FDA planned for second half of 2024 CHATHAM, N.J., March 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and... Read More

Zembrace ® SymTouch ® and Tosymra ® will be marketed by Tonix Medicines, Tonix’s wholly-owned commercial subsidiary Commercial capabilities prepare Tonix for the potential launch in 2025 of Tonmya™ for the management of fibromyalgia, assuming FDA approval CHATHAM, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed... Read More

Tonix recently reported results from second positive Phase 3 trial of Tonmya™ for the management of fibromyalgia In the U.S., New Drug Application (NDA) submission to the FDA planned for the second half of 2024 In Japan, China and most countries in Europe cyclobenzaprine is a New Chemical Entity CHATHAM, N.J., March 12, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp . (Nasdaq: TNXP) (Tonix or the Company), a... Read More

Phase 3 RESILIENT study of Tonmya met its primary endpoint of daily pain reduction (p=0.00005) and achieved statistically significant improvement on all six key pre-specified secondary endpoints with effect sizes on sleep, fatigue, FIQ-R symptoms and FIQ-R function ranging from 0.3 to 0.5 Cognitive dysfunction, or “brain fog,” nominally improved on FIQ-R memory item (p=0.001) where the patients rated their level of memory... Read More

Data support evaluation of the effects of two weeks of TNX-102 SL therapy on severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD) and PTSD after civilian motor vehicle collision in upcoming U.S. DoD-Funded Phase 2 investigator-initiated OASIS trial Nominal improvement in PTSD severity and measures of sleep quality at Week 4 in the HONOR study support development of bedtime TNX-102 SL therapy... Read More

Tonmya is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia, supported by statistically significant results from two Phase 3 trials New Drug Application (NDA) submission to the FDA planned for the second half of 2024 CHATHAM, N.J., March 06, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with... Read More

TNX-1500, a third generation anti-CD40L mAb, was Fc-modified to preserve the activity and bioavailability of first generation mAbs while addressing their thrombosis risk Sanofi projects its Fc-modified humanized anti-CD40L mAb frexalimab will exceed €5B per year in peak sales 1 based on Phase 2 multiple sclerosis data recently published in the New England Journal of Medicine 2 Topline results of TNX-1500 Phase 1 trial... Read More

CHATHAM, N.J., Feb. 29, 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 that Seth Lederman, M.D., Chief Executive Officer, will present at The 6 th International Congress on Controversies in Fibromyalgia in Brussels, Belgium on March 7, 2024. The presentation will... Read More

Topline results expected in the third quarter of 2024; planning a Phase 2 Trial for prevention of kidney transplant rejection Anti-CD40L has multiple possible indications in addition to solid organ and bone marrow transplantation including autoimmune diseases: potential pipeline in a product Sanofi recently published results on their Fc-modified humanized anti-CD40L mAb, frexalimab, for multiple sclerosis in the New England... Read More

Tonix plans to File a Clinical Trial Notification (CTN) in Japan and Investigational New Drug (IND) application in China to support a registration-enabling Asian Phase 3 study without dosage adjustment based on U.S. registrational Phase 3 data Tonmya’s market exclusivity is supported by issued patents in Japan, China, Hong Kong and Taiwan; cyclobenzaprine is a new chemical entity in Japan and China New Drug Application (NDA)... Read More

Bedtime drug being developed by Tonix relieved pain by targeting fibromyalgia's characteristic "non-restorative sleep": Potential for FDA Approval in 2025 CHATHAM, NJ / ACCESSWIRE / February 26, 2024 / People who are suffering from fibromyalgia pain are closer to a new option for treatment that targets their characteristically poor sleep quality. Tonix Pharmaceuticals (TNXP) reported positive study results for its... Read More

CHATHAM, N.J., Feb. 20, 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 that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at the BIO CEO & Investor Conference on February 26, 2024 at 1:30 p.m. ET in New York City.... Read More

Clinical results show that Tonyma™ has broad-spectrum activity, addressing the three core fibromyalgia symptoms: pain, fatigue, and sleep disturbance Tonmya™ has a favorable tolerability profile well-suited for chronic treatment CHATHAM, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of... Read More

Tonmya™ is a potential new first-line therapy, non-opioid analgesic for the management of fibromyalgia, supported by statistically significant results from two Phase 3 trials New Drug Application (NDA) submission to the FDA planned for second half of 2024 Fibromyalgia is a chronic pain condition affecting approximately 10 million U.S. adults that typically persists for years or decades CHATHAM, N.J., Feb. 13, 2024 (GLOBE... Read More

Bedtime TNX-102 SL improves sleep quality in PTSD and is also being developed for the management of fibromyalgia for which NDA preparation is ongoing Investigator-Initiated OASIS Trial at UNC is a Phase 2 180-patient, randomized, placebo-controlled trial in acute trauma patients following motor vehicle collisions One-third of emergency department visits in the U.S. (40-50 million patients per year) involve evaluation after... Read More

Fibromyalgia candidate TNX-102 SL hits primary endpoint of daily pain reduction (p=0.00005) Combination of broad-spectrum relief and favorable tolerability seen as distinguishing, competitive features Company plans to file an NDA for FDA approval in 2H 2024 CHATHAM, NJ / ACCESSWIRE / February 1, 2024 / Tonix Pharmaceuticals (NASDAQ:TNXP ) appears to have a potential new weapon against fibromyalgia for the 6-12 million adults... Read More

Retrospective observational study of electronic medical records of more than 90 million people living in the U.S. Long COVID shares symptoms with chronic overlapping pain disorders like fibromyalgia and appears mechanistically related Tonix is studying TNX-102 SL for both the management of fibromyalgia and management of fibromyalgia-type Long COVID. CHATHAM, N.J., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals... Read More

Results from two positive Phase 3 studies point to Tonmya’s (TNX-102 SL) potential as a new first-line medicine for chronic use in managing fibromyalgia, a debilitating condition suffered by 6-12 million adults in the U.S. New Drug Application (NDA) submission to the FDA planned for second half of 2024 under the 505(b)(2) regulatory pathway CHATHAM, N.J., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp.... Read More

CHATHAM, N.J., Jan. 25, 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 a key opinion leader (KOL) webinar to discuss the positive Phase 3 data of TNX-102 SL for the management of fibromyalgia. The webinar will feature two esteemed thought leaders in the field of... Read More

As previously announced, Phase 3 RESILIENT study of TNX-102 SL met its primary endpoint (p=0.00005) with statistically significant and clinically meaningful daily pain reduction over placebo Results demonstrated a favorable tolerability and side effect profile, including improvement in female sexual function and no increases in weight or blood pressure – three treatment-limiting side effects often observed with currently... Read More

TNX-102 SL is a Non-Opioid Analgesic that Demonstrated Daily Pain Reduction Over Placebo (Primary Endpoint, p = 0.00005) and Showed Positive Effects Across All Six Key Secondary Endpoints in Recently Reported Phase 3 Trial Company Plans to Submit a New Drug Application (NDA) to the FDA in the Second Half of 2024 CHATHAM, N.J., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a... Read More

Led by healthcare-focused institutional investors. $30 million financing upfront with up to an additional $114 million tied to the exercise of warrants. CHATHAM, N.J., Dec. 20, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the Company has signed securities purchase agreements with... Read More

Phase 3 RESILIENT study of TNX-102 SL successfully demonstrated daily pain reduction over placebo (primary endpoint, p = 0.00005) All six key secondary endpoints, including patient global impression, fibromyalgia-specific symptoms and dysfunction, fatigue and sleep measures were significantly improved (all p ≤ 0.001) Positive... Read More

Topline Data from a Registration-Enabling Phase 3 Clinical Trial is Due Later This Month CHATHAM, NJ / ACCESSWIRE / December 14, 2023 / Fibromyalgia is a chronic disorder characterized by widespread pain, fatigue, sleep problems and brain fog. It is a complex condition that often overlaps with other chronic conditions such as... Read More

CHATHAM, N.J., Dec. 11, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Seth Lederman M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the National Academies of Sciences, Engineering, and Medicine Committee on the Current State of Research, Development, and... Read More

TNX-2900 is a proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and eating Preclinical data show magnesium-potentiation increases the potency of exogenous oxytocin Formulations of intranasal oxytocin without magnesium have reported inconsistent results in clinical trials of Prader Willi Syndrome 1,2 CHATHAM, N.J., Dec. 04, 2023 (GLOBE NEWSWIRE) -- Tonix... Read More

CHATHAM, N.J., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Tonix Management will present and host investor meetings at the following December investor conferences: NobleCon 19, Noble Capital Markets’ 19 th Annual Emerging Growth Equity Conference Presenter: Jessica... Read More

Topline results expected late December 2023 RESILIENT is expected to be the final efficacy trial required for submission of a New Drug Application to FDA; first successful Phase 3 trial, RELIEF, achieved statistical significance (p=0.010) Preliminary unaudited rate of adverse-event (AE) related discontinuations in the RESILIENT study was 4.8% which compares favorably with prior studies: RELIEF 6.0% and RALLY 10.7% TNX-102 SL... Read More

Children with Autism Spectrum Disorder are at Risk for Low Bone Density Preliminary Data Suggest that the Administration of Oxytocin May Favorably Impact Bone Formation and Strength Recent Meta-Analysis Reported that Plasma Oxytocin Levels Tend to be Lower in Children with Autism Spectrum Disorder than Controls 1 CHATHAM, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the... Read More

Topline Results from Phase 3 Potentially NDA-Enabling Study of TNX-102 SL in Fibromyalgia Expected Late December 2023: Centrally-Acting Non-Opioid Analgesic Topline Results from Phase 2 Proof-of-Concept Study of TNX-1900 in Chronic Migraine Expected Early December 2023: Intranasal Potentiated Oxytocin Meaningful Progress Made in Obtaining External Support for Clinical Trials from U.S. Government Agencies and Other... Read More

NIAID is conducting early phase clinical trials on select next generation COVID-19 vaccine candidates with the intent to identify promising vaccine candidates TNX-1800, a live virus percutaneous vaccine candidate, is based on Tonix’s recombinant pox virus (RPV) platform Phase 1 clinical trial of TNX-1800 expected to start in the second half of 2024 NIAID will cover the full cost of the clinical trial; Tonix will supply the... Read More

The study did not achieve statistical significance on the primary endpoint Tonix is discontinuing development of TNX-601 ER based on the efficacy results of this study Tonix expects topline data results in December 2023 for its Phase 2 study of TNX-1900 in chronic migraine and Phase 3 study of TNX-102 SL in fibromyalgia CHATHAM, N.J., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a... Read More

Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital TNX-1500 is currently in Phase 1 Clinical Development Tonix is Developing TNX-1500 for Prevention of Kidney Allograft Rejection as the First Indication; Multiple Other Indications, including Autoimmune Disorders, are Planned CHATHAM, N.J., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP)... Read More

Topline results expected early December 2023 Novel formulation of intranasal oxytocin contains magnesium (Mg2+), shown to potentiate the analgesic effects of oxytocin on the oxytocin receptor in animal models TNX-1900 blocks release of CGRP, a key peptide in the pathogenesis of migraine, from trigeminal ganglia neurons while limiting systemic exposure CHATHAM, N.J., Oct. 26, 2023 (GLOBE NEWSWIRE) -- T onix Pharmaceuticals... Read More

Preclinical Data Demonstrate Attenuation of TNX‐801 (horsepox live virus vaccine) Compared to Modern Vaccinia Vaccines TNX-801 is in Preclinical Development as a Novel Vaccine to Protect Against Smallpox and Mpox CHATHAM, N.J., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, presented data on its... Read More

Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital TNX-1500 is Enrolling in a Phase 1 Clinical Trial Tonix is Developing TNX-1500 for Prevention of Kidney Allograft Rejection as the First Indication: Multiple Other Indications, including Autoimmune Disorders, are Planned CHATHAM, N.J., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP)... Read More

Topline Results Expected Early November 2023 Tianeptine, the Active Ingredient in TNX-601 ER, is Not Associated with Sexual Dysfunction or Weight Gain Which are Treatment-Limiting Side Effects of Many Traditional Antidepressants Tianeptine Acts by Directly Restoring Neuroplasticity and Neurogenesis and Limiting the Effects of Oxidative Stress in the Brain CHATHAM, N.J., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals... Read More

CHATHAM, N.J., Oct. 12, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the ThinkEquity Conference on Thursday, October 19, 2023, at 8:00 a.m. ET, and host investor meetings. The conference is being held... Read More

CHATHAM, N.J., Oct. 11, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Zeil Rosenberg, M.D., M.P.H., Executive Vice President, Medical, Tonix Pharmaceuticals, will present at the World Vaccine Congress Europe on Wednesday, October 18, 2023, at 2:45 p.m. CEST in Barcelona, Spain. A... Read More

CHATHAM, N.J., Oct. 09, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Herbert Harris, M.D., Ph.D., Executive Vice President, Translational Medicine of Tonix Pharmaceuticals, provided an overview of Tonix’s TNX-2900 (potentiated intranasal oxytocin) program at the Foundation for Prader-Willi Research (FPWR) Family Conference in... Read More

New patent expected to expire in 2036 Proof of concept data from Phase 2 study for prevention of migraine headache expected in early December 2023 CHATHAM, N.J., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that the European Patent Office (EPO) issued European Patent No. 3242676 to the Company on October 4, 2023. The patent,... Read More

CHATHAM, N.J., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced it has entered into securities purchase agreements with healthcare focused institutional investors for the purchase and sale of 9,000,000 shares of its common stock (or common stock equivalents in lieu thereof) together with Series A warrants to purchase... Read More

CHATHAM, N.J., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase shares of common stock in a public offering. All of the securities to be sold in the offering are to be offered by Tonix.... Read More

$3 million awarded by DoD to University of North Carolina Institute of Trauma Recovery to support a proposed 180-patient, randomized, placebo-controlled trial in acute trauma patients Investigator sponsored trial to evaluate the potential for TNX-102 SL 1 to reduce the frequency and severity of acute stress reaction, acute stress disorder, and post-traumatic stress disorder (PTSD) Acute stress disorder is identified in... Read More

mTNX-1700 (mTFF2-MSA) suppresses tumor growth and increases survival rates in preclinical colorectal cancer models mTNX-1700 shows single agent activity and additive effects in combination with anti-PD-1 mTNX-1700 targets myeloid-derived suppressor cells (MDSCs) in a novel mechanism to treat cancer CHATHAM, N.J., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical... Read More

Oxytocin receptors and CGRP are co-expressed on human trigeminal ganglia neurons and their expression is increased in inflammation Human tissue data support the proposed mechanism of action of TNX-1900 in treating headache: oxytocin treatment blocks the release of CGRP CHATHAM, N.J., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with... Read More

CHATHAM, N.J., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced a poster presentation at the Seventh International Cancer Immunotherapy Conference 2023 (CICON23): Translating Science into Survival. The Conference is being held September 20-23, 2023, in Milan, Italy. A copy of the poster will be made... Read More

Tosymra Nasal Spray 10 mg is a Proprietary Acute Migraine Treatment Approved Under the 505(b)2 Pathway Based on Bioequivalence to Imitrex (sumatriptan) Injection 4 mg GlaxoSmithKline Recently Notified FDA that it will Discontinue Imitrex Nasal Spray 5 mg and 20 mg Products after January 2024 CHATHAM, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a... Read More

TNX-102 SL showed a robust effect size of 0.5 in improving fatigue and showed consistent activity across secondary measures of sleep quality, cognitive function, disability and Patient Global Impression of Change, but did not meet the primary endpoint of multi-site pain reduction at week 14 Findings fulfill the objectives of... Read More

Phase 1/2 Clinical Trial of TNX-801 for the Prevention of Mpox and Smallpox to Commence Following Submission of an IND TNX-801 is Based on a Proprietary Live Virus Vaccine Platform Designed to Stimulate Durable T-Cell Immunity TNX-801 Vaccination Protected Animals from a Lethal Challenge with Monkeypox in Preclinical Testing CHATHAM, N.J., Aug. 21, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP)... Read More

CHATHAM, N.J., Aug. 17, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, will present at the August 2023 Virtual Investor Summit on Thursday, August 24, 2023, at 10:00 a.m. ET. Investors interested in arranging a... Read More

Single Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TNX-1500 Study Designed to Support Planned Phase 2 Trial in Prevention of Kidney Transplant Rejection Multiple Possible Indications, Including Bone Marrow Transplantation and Autoimmune Diseases: Potential Pipeline in a Product TNX-1500 is the First of Tonix’s Internally-Developed Biologic Candidates to... Read More

Topline Results from Four CNS Clinical Trials Expected in the Third and Fourth Quarters of 2023 Fibromyalgia Topline Results Expected in the Fourth Quarter of 2023 for Phase 3 Potentially NDA-Enabling Study of the Centrally-Acting Non-Opioid Analgesic TNX-102 SL Completed Strategic Acquisition of Two Marketed Acute Migraine Products: Zembrace ® SymTouch ® (sumatriptan injection) and Tosymra ® (sumatriptan nasal spray)... Read More

Topline Results Expected Third Quarter 2023 Long COVID Afflicts Approximately 19% of Patients Following COVID-19 1 , and is Expected to be a Global Health Burden Fibromyalgia-Type Long COVID with Multi-Site Pain Affects Approximately 40% of Long COVID Patients CHATHAM, N.J., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today... Read More

CHATHAM, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced the closing of its public offering of 7,000,000 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 7,000,000 shares of common stock in a public offering at a combined offering price of... Read More

Topline Data Expected Fourth Quarter 2023 Final Trial Required for Submission of a New Drug Application, if Successful CHATHAM, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced that it has completed enrollment of its potentially final, confirmatory Phase 3 RESILIENT trial of TNX-102 SL (cyclobenzaprine HCL... Read More

Preliminary Data Show that Oxytocin Decreases Impulsivity and Reduces Food Intake TNX-1900 (Intranasal Potentiated Oxytocin) May Serve as a Novel Neuroendocrine Treatment for Binge-Eating Disorder CHATHAM, N.J., July 31, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the... Read More

CHATHAM, N.J., July 27, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced it has entered into a securities purchase agreement for the purchase and sale of 7,000,000 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 7,000,000 shares of common stock in a public... Read More

CHATHAM, N.J., July 27, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase shares of common stock in a public offering. All of the securities to be sold in the offering are to be offered by Tonix.... Read More

Reallocating Resources to Development of Single Isomer TNX-4300 (Estianeptine) Estianeptine in Preclinical Development Has Demonstrated Key Activities Related to in vivo Novel Object Recognition and in vitro Neuroplasticity, Without the µ-Opioid Receptor Activity of Racemic and (R)-Tianeptine New Findings Support Development of TNX-4300 as a First-in-Class Oral Therapy in Depression, Alzheimer’s Disease and Other Psychiatric... Read More

New Findings Support Development of Racemic Tianeptine and (S)-Tianeptine (Estianeptine) as First-in-Class Oral Therapies in Alzheimer’s Disease and Other Psychiatric and Neurodegenerative Conditions with Memory Deficits (S)-Tianeptine Effects on Novel Object Recognition are Consistent with a Role for PPAR-β/δ Activation in Improving Memory and Cognition Topline Results Expected First Quarter 2024 from the Currently... Read More

CHATHAM, N.J., July 17, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company, today announced that the first participant has been enrolled in a Phase 2 investigator-initiated, proof-of-concept study of TNX-1900 (potentiated intranasal oxytocin) for enhancing social safety learning in social anxiety disorder (SAD). Tonix entered into an agreement with the University of... Read More

Preliminary Data Suggest that Oxytocin May Simultaneously Reduce Energy Intake and Increase Energy Expenditure TNX-1900 (Intranasal Potentiated Oxytocin) May Serve as a Novel Neuroendocrine Weight-Loss Therapeutic for this Patient Population CHATHAM, N.J., July 10, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced... Read More

“Examining the Working Definition for Long COVID” Included Presentations on Emerging Subgroups of Long COVID Patients Defined by Symptoms and Symptom Clusters “Toward a Common Research Agenda in Infection-Associated Chronic Illnesses” Included Presentations on Long COVID Symptoms and Symptom Clusters in the Context of Recognized Infection-Associated Chronic Illnesses such as CFS/ME Topline Results from Tonix’s Phase 2... Read More

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,... Read More

Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) are Indicated for the Treatment of Acute Migraine in Adults Strategic Acquisition Helps Build Tonix’s Commercial Capabilities and Infrastructure Ahead of Potential Launch of TNX-102 SL for the Treatment of Fibromyalgia Acute Migraine Products Complement Tonix’s Current Intranasal Clinical Development Program of TNX-1900 for Migraine Prevention... Read More

Previously Disclosed Data Demonstrated that TNX-102 SL Achieved Statistically Significant Pain Reduction Over Placebo at Week 14 (Primary Endpoint, p=0.01) and Was Generally Safe and Well Tolerated Topline Data from RESILIENT, a Potentially Confirmatory Registration-Enabling Phase 3 Fibromyalgia Trial of TNX-102 SL, Expected Fourth Quarter 2023 CHATHAM, N.J., June 15, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding... Read More

Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital TNX-1500 is Expected to Enter Phase 1 Clinical Development in Third Quarter 2023 CHATHAM, N.J, June 07, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced data from two oral presentations and one poster presentation... Read More

Tianeptine’s Mechanism of Restoring Neuroplasticity and Neurogenesis by Dual PPAR-β/δ and PPAR-γ Agonism Supports Development as a First-in-Class Oral Therapy for Psychiatric and Neurodegenerative Diseases Racemic Tianeptine, or TNX-601 ER, is Enrolling in a Potentially Pivotal Phase 2 Study for the Treatment of Major Depressive Disorder; Results from Interim Analysis Expected Fourth Quarter 2023 Single (S)-Isomer of... Read More

CHATHAM, N.J., May 31, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an upcoming oral presentation by Ryo Otsuka, Ph.D., and poster presentation by Kohei Kinoshita, M.D at the 2023 American Transplant Congress (ATC). Both presenters are faculty members at the Center for Transplantation Sciences, Massachusetts... Read More

CHATHAM, N.J., May 30, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the 2023 BIO International Convention being held June 5-8, 2023 in Boston, Mass. The presentation will take place on Tuesday, June 6, 2023 at 4:15 p.m.... Read More

CHATHAM, N.J., May 25, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. On May 24, 2023, Tonix received a letter from The Nasdaq Stock Market LLC stating that because Tonix’s shares had a... Read More

CHATHAM, N.J., May 25, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, will present a poster at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held May 30 – June 2, 2023, at the Loews Miami Beach Hotel in Miami Beach,... Read More

CHATHAM, N.J., May 24, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the June 1 st Virtual Investor Summit on Thursday, June 1, 2023, at 10:30 a.m. ET. Investors interested in arranging a meeting with the Company’s management during the conference... Read More

TNX-4300 is a Dual PPAR-β/δ and PPAR-γ Agonist, Free from µ-Opioid Receptor Activity TNX-4300’s Mechanism of Restoring Neuroplasticity Supports Development as a First-in-Class Oral Therapy for Depression, Bipolar Disorder, Alzheimer’s Disease and Parkinson’s Disease Restoring Atrophied Neuronal Connections in Psychiatric and Neurological Diseases Seen as Paramount to Achieving Better and More Durable Outcomes CHATHAM, N.J.,... Read More

Intranasal Oxytocin Blocks the Release of CGRP in Animal Models Intranasal Oxytocin is the Core Technology of TNX-1900 for Migraine Oxytocin Treatment Affects a Pathway that is Distinct from the Recently Available CGRP Migraine Treatment Drug Class CHATHAM, N.J., May 22, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that it has entered... Read More

CHATHAM, N.J., May 18, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that management will participate in the A.G.P. Virtual Healthcare Conference and host investor meetings. The conference is being held May 23-24, 2023. In addition, Seth Lederman, M.D., Chief Executive Officer of Tonix, will participate in a panel discussion titled, “... Read More

Research Supports Direct Role for Restoring Neuroplasticity and Upsets Previously Held Beliefs About the Significance of Neurotransmitters in Treating Depression Findings Explain Why Tianeptine Is Not Associated with Sexual Dysfunction and Weight Gain Mechanism Supports Development of TNX-601 ER for a Broad Range of Neurodegenerative Diseases and Psychiatric Disorders CHATHAM, N.J., May 17, 2023 (GLOBE NEWSWIRE) -- Tonix... Read More

CHATHAM, N.J., May 09, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it will effect a 1-for-6.25 reverse stock split of its outstanding common stock. This will be effective for trading purposes as of the commencement of trading on May 10, 2023. The reverse stock split was previously approved by the Board of... Read More

Prioritizing Late-Stage Clinical CNS Programs in Fibromyalgia, Depression, Migraine, and Cocaine Intoxication Topline Results Expected in Fourth Quarter 2023 for Potentially Confirmatory Phase 3 Trial of TNX-102 SL for Fibromyalgia Potentially Pivotal Phase 2 Trial of TNX-601 ER for Major Depressive Disorder (MDD) Enrolling; TNX-601 ER Represents an Innovative Approach for MDD through Restoration of Neuroplasticity and... Read More

Multiple Additional Indications Possible, Including Autoimmune Diseases: Pipeline within a Product Published Non-Human Primate Studies Show TNX-1500 Prolongs Renal and Heart Allograft Survival Phase 1 Clinical Trial of TNX-1500 Expected to Start Third Quarter 2023 CHATHAM, N.J., May 04, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced the... Read More

No Evidence of Sexual Dysfunction or Weight Gain with its Active Ingredient as a Prescription Drug Outside the U.S. Tianeptine Rescues Neuron Connectivity in Animal Models of Stress CHATHAM, NJ / ACCESSWIRE / April 27, 2023 / A new antidepressant drug candidate being developed by researchers at Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) is said to have mechanistic activity and therapeutic features that set it apart... Read More

CHATHAM, N.J., April 19, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced the presentation of two posters with research results on TNX-1700 (recombinant TFF2 – albumin fusion peptide) at the American Association for Cancer Research (AACR) Annual Meeting, held April 14-19, 2023, in Orlando, Fla. Copies of the Company’s posters are... Read More

CHATHAM, N.J., April 17, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced the on-line publication of two papers 1,2 in the American Journal of Transplantation by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital (MGH) in collaboration with Tonix Pharmaceuticals. The data involve studies of Tonix’s TNX-1500... Read More

Streamlining Phase 3 Fibromyalgia and Phase 2 Chronic Migraine Trials by Eliminating Interim Analyses Topline Results Expected for Both Programs in Fourth Quarter 2023 CHATHAM, N.J., April 13, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that it is eliminating the interim analyses in its registration-enabling, confirmatory Phase 3... Read More

Preclinical data demonstrate the efficacy of TNX‐801 vaccination against mpox virus challenge in a non-human primate model Phase 1 trial with TNX-801 for the prevention of mpox and smallpox is expected to start in the second half of 2023 CHATHAM, N.J., April 06, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, presented data from... Read More

CHATHAM, N.J., April 05, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that two posters with research results on TNX-1700 (recombinant TFF2 – albumin fusion peptide) will be presented as posters at the American Association for Cancer Research (AACR) Annual Meeting being held April 14-19, 2023, in Orlando, Fla. These data demonstrate... Read More

Prioritizing Clinical-Stage CNS Programs in Fibromyalgia, Depression, Migraine, and Cocaine Intoxication Deprioritizing COVID-19 Related Programs and Pending Posttraumatic Stress Disorder (PTSD) Trial Cash and Cash Equivalents Totaled Approximately $120.2 Million at December 31, 2022 CHATHAM, N.J., April 04, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical... Read More

CHATHAM, N.J., March 30, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present an oral presentation and poster at the 5 th International Congress on Controversies in Fibromyalgia being held March 30-31, 2023 at the Austria Trend Hotel... Read More

CHATHAM, N.J., March 27, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Zeil Rosenberg, M.D., M.P.H., Executive Vice President, Medical and Farooq Nasar, Ph.D., Senior Principal Investigator, both of Tonix Pharmaceuticals, will deliver oral presentations at the World Vaccine Congress, which will be held in Washington D.C., April 3... Read More

CHATHAM, N.J., March 23, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Herbert Harris, M.D., Ph.D., Executive Vice President, Translational Medicine of Tonix Pharmaceuticals, delivered an oral presentation on March 23, 2023, at the Rare Disease Innovation and Partnership Summit being held as a hybrid event in Philadelphia, Pa. A... Read More

CHATHAM, N.J., March 23, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will deliver an oral presentation and the Company will present a poster at the 5th International Congress on Controversies in Fibromyalgia being held March 30-31, 2023 at the Austria Trend... Read More

CHATHAM, N.J., March 22, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the Virtual March Investor Summit on Wednesday, March 29, 2023, at 9:00 a.m. ET. Investors interested in arranging a meeting with the Company’s management during the conference... Read More

CHATHAM, N.J., March 16, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Herbert Harris, M.D., Ph.D., Executive Vice President, Translational Medicine of Tonix Pharmaceuticals, will deliver a presentation at the Rare Disease Innovation and Partnership Summit, which will be held as a hybrid event in Philadelphia, Pa., March 21 -... Read More

Results from Planned Interim Analysis Expected Fourth Quarter 2023 Approximately 21 Million Adults in U.S. Suffer From a Major Depressive Episode Each Year TNX-601 ER is a Once-Daily Tablet that is Bioequivalent to Three-Times-Daily Tianeptine Sodium Immediate Release (IR) that has been available in Europe, Asia and Latin America for More than Three Decades Tianeptine IR is Associated with Low Incidences of Sexual... Read More

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... Read More

Murine TNX-1700 (mTNX-1700) Enhances Anti-Tumor Activity of PD-1 Blockade in Mouse Models of Colorectal Cancer TNX-1700 is in Development as Monotherapy and in Combination with Anti-PD-1 Checkpoint Inhibitor Therapy for Colorectal and Gastric Cancers In Animal Models of Colorectal Cancer, mTNX-1700 Treatment Leads to the Activation of Cancer-Killing CD8 + T Cells and Limits Immune Evasion by Cancer Cells CHATHAM, N.J., March... Read More

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.... Read More

Symptoms of Long COVID, Like Multi-Site Pain, Fatigue and Insomnia, are the Hallmarks of Chronic Pain Syndromes Like Fibromyalgia and Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) Event Co-Hosted by the Biotechnology Innovation Organization (BIO) and Solve M.E., an Advocacy Group for CFS/ME CHATHAM, N.J., Feb. 22, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the... Read More

CHATHAM, N.J., Feb. 16, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at a virtual event co-hosted by BIO and Solve M.E. titled, “Long COVID: What Will it Take to Accelerate Therapeutic Progress?”, which is... Read More

Immunocompromised Individuals, Including Organ Transplant Recipients, Are at Increased Risk of Severe COVID-19 and Poor Clinical Outcomes SARS-CoV-2 has Mutated to Evade the Formerly EUA-Approved Monoclonal Antibody Therapies and Preventatives CHATHAM, N.J., Feb. 13, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that it has exercised... Read More

Preclinical data demonstrate the efficacy of TNX‐801 vaccination against monkeypox virus challenge in an animal model Phase 1 trial with TNX-801 for the prevention of monkeypox and smallpox is expected to start in the second half of 2023 CHATHAM, N.J, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the... Read More

Results from Planned Interim Analysis Expected Fourth Quarter 2023 Approximately Four Million in U.S. Suffer from Chronic Migraine Development of TNX-1900 Also Planned for Treatment of Episodic Migraine CHATHAM, N.J., Feb. 06, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled... Read More

CHATHAM, N.J., Feb. 03, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp . (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will participate virtually in the BIO CEO & Investor Conference, which is being held February 6-9, 2023. The Company’s pre-recorded presentation will be... Read More

The Acquired Portfolio of Infectious Disease Assets Includes a Class of Potential Broad Spectrum Oral Antiviral Agents, TNX-3900 with a Host-Directed Mechanism Tonix Plans to Develop the TNX-3900 Series of Molecules as Oral Antivirals Either as Monotherapy or in Combination with Other Antivirals The TNX-3900 Class of Antivirals Has a Novel Mechanism of Action Based on Inhibition of Certain Cathepsin Proteases which are... Read More