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, ...

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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 Growth Equity Conference, being held December 3-4 in Boca Raton, Fla. Investors inte ...

Dublin, Nov. 21, 2024 (GLOBE NEWSWIRE) -- The "Muscarinic Acetylcholine Receptor M1 Antagonists - Pipeline Insight, 2024" drug pipelines has been added to ResearchAndMarkets.com's offering.This report provides comprehensive insights about 5+ companies and 8+ pipeline drugs in Muscarinic Acetylcholine Receptor M1 Antagonists pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of ...

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. Investors interested in arranging a meeting with the Company’s management virtually d ...

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 TNX-801 was shown to be more than 10- to 1,000-fold more attenuated (or less virul ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from _________ to _________ Commission file number: 001-36019 TONIX PHARMACEUTICALS HOLDING CORP. (Exact name of registrant as specified in its charter) Nevada ...