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 investor meetings. The conference is being held at the Mandarin Oriental, New York in New ...

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 accelerated development of its host-directed broad-spectrum antiviral program TNX-4200 ...

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 announced that the United States Patent and Trademark Office issued U.S. Patent No. 12,097,18 ...

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 develop manufacturing processes in preparation for potential GMP manufacturing CHATHAM, ...

Core Insights - Tonix Pharmaceuticals is on track to submit a New Drug Application (NDA) for TNX-102 SL for fibromyalgia in the second half of 2024, having completed successful pre-NDA meetings with the FDA [1][4] - The FDA has granted Fast Track designation for TNX-102 SL, indicating its potential to address an unmet medical need in treating fibromyalgia [2][4] - The company has received a contract from the U.S. Department of Defense for up to $34 million over five years to develop a broad-spectrum antiviral drug [1][12] Product Development Highlights - TNX-102 SL is a centrally-acting, non-opioid analgesic intended for the management of fibromyalgia, with a once-daily administration at bedtime [3] - The company is also advancing TNX-4200, a broad-spectrum antiviral program, supported by the DoD contract [2][12] - TNX-801, a vaccine in development for mpox, has shown positive preclinical efficacy, providing immune protection against lethal challenges [14] Financial Overview - As of June 30, 2024, Tonix had $4.2 million in cash and cash equivalents, down from $24.9 million at the end of 2023 [19] - Net product revenue for the second quarter of 2024 was approximately $2.2 million, with a cost of sales of about $3.4 million [20] - The net loss available to common stockholders for the second quarter of 2024 was $78.8 million, compared to a net loss of $28.4 million for the same period in 2023 [23] Market Strategy and Research - Tonix is collaborating with EVERSANA to assess the U.S. market opportunity for TNX-102 SL, indicating a high level of physician interest in the product [5] - The company plans to conduct a Phase 2 trial for TNX-102 SL to treat Acute Stress Disorder, supported by a $3 million contract from the DoD [5][6] - TNX-1300, a biologic for cocaine intoxication, is expected to enter Phase 2 clinical studies in the third quarter of 2024 [6] Pipeline and Future Prospects - The company has a diverse pipeline including TNX-1500 for organ transplant rejection and autoimmune disorders, and TNX-2900 for Prader-Willi syndrome [9][10] - Tonix's immunology and infectious disease portfolios are being developed to address significant health challenges, with ongoing studies and collaborations [10][12] - The company aims to leverage its infrastructure to expedite the launch of TNX-102 SL pending FDA approval, expected in 2025 [24]

Diagnosing fibromyalgia in Long COVID patients is expected to expand the potential addressable market for Tonmya relative to pre-COVID-19 pandemic estimates2 Dr. Lederman continued, "Prior to the COVID-19 pandemic, the prevalence of fibromyalgia was estimated to be more than 10 million adults in the U.S.4 The U.S. Census Bureau, the National Center for Health Statistics Household Pulse Survey and the Centers for Disease Control and Prevention (CDC) estimate that approximately 5.3% of U.S. adults suffer from ...

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 biopharmaceutical company with marketed products and a pipeline of development candidates, today anno ...

Approximately 10 million adults in the U.S. are affected by fibromyalgia, predominantly women CHATHAM, N.J., July 08, 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 receipt of the formal minutes from a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for Tonmya™ (cyclobenzaprine HCl sub ...

NDA submission target confirmed for second half 2024, with potential for FDA approval in second half 2025 On June 20, 2024, Tonix announced receipt of formal minutes of a pre-NDA Type-B Chemistry, Manufacturing, and Controls (CMC) meeting confirming alignment with the FDA on key CMC topics to support the NDA submission. Today's announcement confirms alignment with the nonclinical, clinical pharmacology and clinical features of the NDA submission, following completion of Tonix's second and final pre-NDA meet ...

Tonix will utilize its state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at its research and development center (RDC) located in Frederick, Md., as well as experienced personnel in-house. The RDC is located in Maryland's 'I-270 biotech corridor' and is close to the center of the U.S. biodefense research community. Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializ ...