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