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 well-tolerated with a favorable safety profile Anti-CD40L has multiple potential indi ...

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 ...

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 th ...

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 ...

Tonix Pharmaceuticals Form 8-K Exhibit 10.01 CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS PRIVATE OR CONFIDENTIAL. THE OMISSIONS HAVE BEEN INDICATED BY "[***]." JGB Collateral LLC 246 Post Road East, 2 Floor Westport, CT 06880 February 3, 2025 TONIX PHARMACEUTICALS HOLDING CORP. 26 Main Street Suite 101 Chatham, NJ 07928 Attention: Seth Lederman, Jessica Morris and Bradley Saenger Email: Seth.lederman@tonixpharma.com; Jessica.moris@tonixpharma.com ...

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 sha ...

Company Updates - Tonix Pharmaceuticals appointed Gary Ainsworth as Vice President, Market Access, effective immediately Mr Ainsworth brings over two decades of industry and market access experience, including leadership roles at Eversana Intouch, Havas Gemini, Baxter International, Roche Laboratories, and Sanofi predecessor companies [1][2] - The U S Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for marketing authorization of TNX-102 SL for fibromyalgia management TNX-102 SL is a non-opioid, centrally-acting analgesic targeting a chronic pain condition that predominantly affects women [1][3] Product Pipeline - Tonix's development portfolio focuses on central nervous system (CNS) disorders, with TNX-102 SL as a priority candidate for fibromyalgia management The product candidate has completed two statistically significant Phase 3 studies and received FDA Fast Track designation [4] - The company is developing TNX-1300 (cocaine esterase) for cocaine intoxication, which has FDA Breakthrough Therapy designation and is supported by a grant from the U S National Institute of Drug Abuse and Addiction [4] - Tonix's immunology portfolio includes TNX-1500, an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) for preventing allograft rejection and treating autoimmune diseases [5] - The company is advancing TNX-2900 for Prader-Willi syndrome and TNX-801, a vaccine for mpox Additionally, Tonix secured a $34 million contract with the U S DoD's Defense Threat Reduction Agency (DTRA) to develop TNX-4200, a small molecule broad-spectrum antiviral agent targeting CD45 [5] Commercial Operations - Tonix Medicines, the company's commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for acute migraine treatment in adults [5] - The company operates a state-of-the-art infectious disease research facility in Frederick, Md [5]

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: 8th Annual Neuroscience Innovation Forum by Sachs Associates Company PresentationPresenter:Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuti ...

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 its treatment in more than 15 years NDA based on two statistically significant Phas ...

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 fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years, ...