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 ...

Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on developing, licensing, and commercializing therapeutics for human diseases, particularly in central nervous system (CNS) disorders [2] - The company has a pipeline that includes product candidates for fibromyalgia, acute stress reaction, cocaine intoxication, organ transplant rejection, autoimmunity, and cancer [2] Recent Developments - Tonix has been awarded an Other Transaction Agreement (OTA) with the Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop broad-spectrum antiviral agents [13][18] - The funding aims to enhance the medical readiness of military personnel in biological threat environments and supports the company's antiviral discovery program [9][18] Product Pipeline - Tonix's priority is to submit a New Drug Application (NDA) for Tonmya (TNX-102 SL) in the second half of 2024, which has completed two statistically significant Phase 3 studies for fibromyalgia management [2][7] - The company is also developing TNX-1300 for cocaine intoxication and TNX-1500, a monoclonal antibody for preventing organ transplant rejection and treating autoimmune diseases [2] Research and Development Facilities - Tonix utilizes advanced research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility located in Frederick, Maryland [1] Strategic Focus - The company is focusing on optimizing its TNX-4200 program, which aims to develop an orally available CD45 antagonist with broad-spectrum efficacy against various viral families [5][18] - Tonix's approach includes leveraging previous research on phosphatase inhibitors to optimize lead compounds for therapeutic intervention against biothreat agents [18]

Tonix Pharmaceuticals doesn't have the finer details of this offering ready just yet. That means we don't know how many shares it includes, what they will be priced at or how much it expects in gross proceeds. To be more specific, Tonix Pharmaceuticals wants to use the money to prepare a new drug application for its Tonmya product candidate to treat fibromyalgia. It could also use the funds to pay down its debts. Investors will note that Tonix Pharmaceuticals announced this proposed public offering right af ...

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 warrant in lieu thereof). The closing of the public offering is expected to take place ...

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 warrant in lieu thereof). The closing of the public offering is expected to take place ...