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 PRESS RELEASE

Tonix Pharmaceuticals Presented Data on Potential Mpox Vaccine TNX-801...

Tonix Pharmaceuticals Presented Data on Potential Mpox Vaccine TNX-801 at World Vaccine Congress Washington 2025 TNX-801 is a single-dose, live virus vaccine in development to protect against mpox and smallpox TNX-801 protects immunocompromised animals from a lethal challenge with clade IIa monkeypox virus Durability of TNX-801 vaccination shown by six-month protection of animals from a lethal challenge with rabbitpox Tolerability of TNX-801 demonstrated in immunocompromised animals by no spreading to blood or tissues, even at high doses CHATHAM, N.J., April 24, 2025 (GLOBE NE...

 PRESS RELEASE

Tonix Pharmaceuticals Announces Oral Presentation and Panel Participat...

Tonix Pharmaceuticals Announces Oral Presentation and Panel Participation at the World Vaccine Congress Washington 2025 CHATHAM, N.J., April 16, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the Company will deliver an oral presentation and lead a panel discussion at the World Vaccine Congress Washington 2025, which will be held in Washington, D.C., April 22-24, 2025. A copy of the Company’s presentation wi...

 PRESS RELEASE

Tonix Pharmaceuticals and Makana Therapeutics Announce Collaboration C...

Tonix Pharmaceuticals and Makana Therapeutics Announce Collaboration Combining Tonix’s Anti-CD40L Monoclonal Antibody (TNX-1500) with Makana’s Genetically Engineered Organs in Preclinical and Clinical Xenotransplantation Studies Agreement includes the use of Tonix’s TNX-1500, as part of an immunomodulatory regimen to reduce rejection of Makana’s genetically engineered pig organs in xenotransplantation Establishes framework for Makana’s kidney, heart and islet cell programs to utilize TNX-1500 for preclinical studies in support of regulatory filings for potential use in human recipients ...

 PRESS RELEASE

Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatm...

Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the American Academy of Pain Medicine (AAPM) 2025 Annual Meeting 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 fibr...

 PRESS RELEASE

Tonix Pharmaceuticals to Present at the 2025 Jones Trading Healthcare ...

Tonix Pharmaceuticals to Present at the 2025 Jones Trading Healthcare and Innovation Conference CHATHAM, N.J., April 02, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the 2025 Jones Trading Healthcare and Innovation Conference on Wednesday, April, 9, 2025, at 10:00 a.m. PT (1:00 p.m. ET) in Las Vegas, Nev. Investors interested in arranging ...

 PRESS RELEASE

Tonix Pharmaceuticals Launches TONIX ONE™, a Fully-Integrated Digital ...

Tonix Pharmaceuticals Launches TONIX ONE™, a Fully-Integrated Digital Platform Designed to Help Patients Better Understand and Manage Their Migraine Condition Tonix expands its all-in-one platform, partnering with the world’s leading migraine diary app, enhancing disease education and prescription access 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...

 PRESS RELEASE

Tonix Pharmaceuticals Announces Presentation at the American Academy o...

Tonix Pharmaceuticals Announces Presentation at the American Academy of Pain Medicine (AAPM) 2025 Annual Meeting CHATHAM, N.J., March 27, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer, will present a poster at the AAPM 2025 Annual Meeting, PainConnect, in Austin, Texas on April 5, 2025, at 11:45 a.m. CT. The meeting will take place from April 3-6, 2025. A copy of the Company’s p...

 PRESS RELEASE

Tonix Pharmaceuticals Announces that FDA Will Not Require an Advisory ...

Tonix Pharmaceuticals Announces that FDA Will Not Require an Advisory Committee Meeting to Discuss New Drug Application for TNX-102 SL for the Management of Fibromyalgia 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 bi...

 PRESS RELEASE

Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financ...

Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights August 15, 2025, is the FDA PDUFA goal date for TNX-102 SL for the management of fibromyalgia; If approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years Company expects to have sufficient cash to fund planned operations beyond the FDA PDUFA goal date and anticipated fourth quarter 2025 launch of TNX-102 SL for fibromyalgia; $98.8 million in cash as of December 31, 2024 Announced positive topline results from Phase 1 study of TNX-150...

 PRESS RELEASE

Tonix Pharmaceuticals Announces Presentation at BIO-Europe Spring 2025

Tonix Pharmaceuticals Announces Presentation at BIO-Europe Spring 2025 CHATHAM, N.J., March 13, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the 2025 BIO-Europe Spring Convention being held March 17-19, 2025, in Milan, Italy. The Company’s presentation will take place on Monday, March 17, 2025, at 2:00 p.m. CET in the Ex...

 PRESS RELEASE

Tonix Pharmaceuticals to Present at the Zacks SCR Life Sciences Virtua...

Tonix Pharmaceuticals to Present at the Zacks SCR Life Sciences Virtual Investor Forum on March 13th 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. Pre-register for Tonix’s virtual presentation at . This will be a live, inter...

 PRESS RELEASE

Tonix Pharmaceuticals Announces Grant by Medical CBRN Defense Consorti...

Tonix Pharmaceuticals Announces Grant by Medical CBRN Defense Consortium (MCDC) for Development of TNX-801, the Company’s Single-Dose Mpox and Smallpox Vaccine Candidate 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‐8...

 PRESS RELEASE

Tonix Pharmaceuticals to Present at the 2025 Virtual Investor Summit

Tonix Pharmaceuticals to Present at the 2025 Virtual Investor Summit 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 interested in arranging a meeting with the Company’s management virtually during the confere...

 PRESS RELEASE

Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatm...

Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at 7th International Congress on Controversies in Fibromyalgia 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 If a...

 PRESS RELEASE

Tonix Pharmaceuticals Recently Announced Preliminary Full Year 2024 Op...

Tonix Pharmaceuticals Recently Announced Preliminary Full Year 2024 Operating Results and Year-End Cash 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 or the Company), a fully-integrated biopharmaceutical compan...

 PRESS RELEASE

Tonix Pharmaceuticals Announces Positive Topline Results from Phase 1 ...

Tonix Pharmaceuticals Announces Positive Topline Results from Phase 1 Trial for TNX-1500, a Next Generation anti-CD40L mAb Candidate for Prevention of Kidney Transplant Rejection and Treatment of Autoimmune Diseases 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 fo...

 PRESS RELEASE

Tonix Pharmaceuticals to Participate in the 2025 BIO CEO & Investor Co...

Tonix Pharmaceuticals to Participate in the 2025 BIO CEO & Investor Conference 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. Investors interested in arranging a meeting with the Company’s management during the c...

 PRESS RELEASE

Tonix Pharmaceuticals Promotes Siobhan Fogarty to Chief Technical Offi...

Tonix Pharmaceuticals Promotes Siobhan Fogarty to Chief Technical Officer 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 products and a pipeline of development candidates, today announced the promotion of Siobhan...

 PRESS RELEASE

Tonix Pharmaceuticals Announces 1-for-100 Reverse Stock Split

Tonix Pharmaceuticals Announces 1-for-100 Reverse Stock Split 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 trading on February 5, 2025. The reverse stock split is intended to increase the per share trading price of ...

 PRESS RELEASE

Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team w...

Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team with Appointment of Gary Ainsworth as Vice President of Market Access Mr. Ainsworth brings over two decades of industry and market access experience to Tonix U.S. Food and Drug Administration (FDA) recently assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for U.S. marketing authorization of TNX-102 SL for the management of fibromyalgia CHATHAM, N.J., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceu...

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