Breaking News: Tonix Pharmaceuticals (NASDAQ: TNXP) Goes Green Early on Key FDA Milestone Announcement

View in browser Immediately Add Tonix Pharmaceuticals (NASDAQ: TNXP) to Your Watchlist!   This profile has several potential catalysts requiring your immediate  attention including…   Low Float: A Recent Reverse-Split Left Tonix Pharmaceuticals (NASDAQ: TNXP) With A Float Of Less Than 3 Mln Shares, Leading To Potential High Volatility And Amplified Impact From Positive News.   Market Surge: The Company Surged 59% In The Last Week And A Half, Surpassing Its 5-Day Moving Average Of $.7721 And Reaching A New July High of $.95.   Innovative Development: Tonix Is Pioneering Treatments For CNS Disorders, Immunology, And Infectious Diseases, Focusing On Significant Unmet Needs.   Clinical Success: Tonmya™ (TNX-102 SL) Has Shown Significant Efficacy In Phase 3 Trials For Fibromyalgia, With Notable Improvements In Pain And Sleep, And Is Set For An NDA Submission In 2024.   Breakthrough Therapy: TNX-1300, For Treating Coc-aine Intoxication, Has Received FDA Breakthrough Therapy Designation And Is In Phase 2 Trials, Addressing Critical Public Health Issues.   Strategic Contract: Tonix Secured A $34 Mln Contract From The Defense Threat Reduction Agency (DTRA) To Develop TNX-4200, A Broad-Spectrum Antiviral, Emphasizing The Importance Of Their Research In National Defense.   July 8, 2024   Dear reader,   Tonix Pharmaceuticals (NASDAQ: TNXP) goes green early after releasing breaking news.   Better hurry, because (TNXP) is triggering 14 Bullish Signals on TradingView's Technical Analysis tool on the 1-minute frame.   Tonix Pharmaceuticals (NASDAQ: TNXP) has just announced a successful pre-NDA meeting with the FDA for Tonmya™, aiming to provide a new non-opioid solution for fibromyalgia.    With around 10M U.S. adults affected, this development is a significant step forward.    The company plans to submit the NDA in the latter half of 2024, targeting potential approval in 2025. CEO Seth Lederman, M.D., emphasized Tonmya's potential to fill a critical gap in fibromyalgia treatment.   For Full Story Click Here. Keep reading for my original Tonix Pharmaceuticals (NASDAQ: TNXP) write up.   A recent reverse-split has left this little-known biopharma with a razor-thin float of less than 3 Mln shares.   This company just surged approximately 59% in the last week and a half, crushing its 5-day moving average (MA) of $0.7721 on its way to a new July high of $0.95.    Could this be the beginning of something bigger? Immediately pull up Tonix Pharmaceuticals (NASDAQ: TNXP) and add it to your watchlist for the first thing this morning.   Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is a pioneering biopharmaceutical company dedicated to developing, licensing, and commercializing therapeutics that address a wide range of human diseases.    With a mission to alleviate suffering and improve health outcomes, Tonix's robust development portfolio is particularly focused on central nervous system (CNS) disorders, immunology, rare diseases, and infectious diseases.    This comprehensive approach positions Tonix as a key player in the biopharmaceutical industry, driving significant advancements in medical science.   Focus on Central Nervous System Disorders Tonix's primary objective within CNS disorders is the development of Tonmya™ (TNX-102 SL), a sublingual tablet of cyclobenzaprine hydrochloride designed for the management of fibromyalgia.    This chronic pain disorder affects 6 to 12 Mln adults in the U.S., leading to widespread pain, fatigue, and cognitive disturbances.    Tonmya™ has shown exceptional promise in two Phase 3 clinical trials, demonstrating significant reductions in daily pain and improvements in sleep quality and overall symptoms.    The company is preparing to submit a New Dr-ug Application (NDA) to the FDA in the second half of 2024. Beyond fibromyalgia, TNX-102 SL is also being developed to treat acute stress reactions and fibromyalgia-type Long CVD, broadening its potential impact and therapeutic applications.   Advancements in Treating Co-caine Intoxication Tonix's CNS portfolio also includes TNX-1300, a biologic designed to treat co-caine intoxication. This innovative treatment has received FDA Breakthrough Therapy designation and is currently in Phase 2 development, supported by a grant from the National Institute of Dr-ug Abuse. TNX-1300 addresses a critical unmet need in substance abuse treatment, showcasing Tonix's commitment to tackling complex health challenges.   Cutting-Edge Immunology and Antiviral Programs Tonix's immunology portfolio features biologics aimed at preventing organ transplant rejection, treating autoimmune diseases, and combating cancer. A standout candidate is TNX-1500, a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154), which is being developed to prevent allograft rejection and treat autoimmune diseases.   In a landmark achievement, Tonix has been awarded a contract worth up to $34 Mln by the Defense Threat Reduction Agency (DTRA), a branch of the U.S. Department of Defense (DoD). This funding will accelerate the development of TNX-4200, an orally available CD45 antagonist with broad-spectrum antiviral efficacy. The program focuses on creating medical countermeasures to protect military personnel from biological threats, advancing TNX-4200 through preclinical and early clinical stages.   Leveraging State-of-the-Art Research Capabilities Tonix's research and development capabilities are bolstered by its state-of-the-art laboratory facilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at its Frederick, Md. research center. Situated in Maryland's 'I-270 biotech corridor', this location is central to the U.S. biodefense research community, enhancing Tonix's ability to develop innovative solutions for complex health threats.   Commercial Success and Marketed Products Tonix Medicines, the commercial subsidiary of Tonix Pharmaceuticals, successfully markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.    These marketed products not only generate steady revenue but also demonstrate Tonix's capacity to bring effective therapeutics to market.   Tonix Pharmaceuticals (NASDAQ: TNXP) stands at the forefront of biopharmaceutical innovation, with a diverse and advanced pipeline targeting CNS disorders, immunology, rare diseases, and infectious diseases.    The recent $34 Mln contract from the DTRA underscores the company's strategic importance and capability to address urgent medical needs in both civilian and military settings.    As Tonix prepares for the NDA submission of Tonmya™ and continues to advance its other promising programs, it is well-positioned to make substantial contributions to medical science and patient care, cementing its status as a leader in therapeutic innovation.   With its strategic focus, advanced research capabilities, and commitment to addressing unmet medical needs, Tonix Pharmaceuticals (NASDAQ: TNXP)  is set to redefine the landscape of biopharmaceutical development, promising a future filled with groundbreaking medical advancements.   7 Reasons to Immediately Add Tonix Pharmaceuticals Holding Corp. (TNXP) To Monday's Watchlist…   Low Float: A recent reverse-split has left Tonix Pharmaceuticals (NASDAQ: TNXP) with a razor-thin float of less than 3 Mln shares. This low float can lead to significant volatility and price movements, potentially amplifying the impact of positive news and developments. Recent Market Recognition: This company just surged approximately 59% in the last week and a half, crushing its 5-day moving average (MA) of $0.7721 on its way to a new July high of $.95. Innovative Therapeutic Development: Tonix Pharmaceuticals (NASDAQ: TNXP) is pioneering in developing treatments for a wide array of human diseases, focusing on areas with significant unmet needs, such as CNS disorders, immunology, and infectious diseases. Promising Clinical Results: Tonmya™ (TNX-102 SL), designed for managing fibromyalgia, has shown significant efficacy in two Phase 3 trials, with notable improvements in pain reduction and sleep quality, and is poised for an NDA submission to the FDA in 2024. Expanding Treatment Applications: Beyond fibromyalgia, TNX-102 SL is being explored for acute stress reactions and fibromyalgia-type Long CVD, broadening its therapeutic scope and potential market impact. FDA Breakthrough Therapy Designation: TNX-1300, developed for treating co-caine intoxication, has received this prestigious designation and is advancing through Phase 2 trials, highlighting its potential to address critical public health issues. Landmark Deal: Tonix Pharmaceuticals (NASDAQ: TNXP) secured a contract worth up to $34 Mln from the Defense Threat Reduction Agency (DTRA) to develop TNX-4200, an orally available broad-spectrum antiviral, emphasizing the strategic significance of their research in national defense. Tonix Pharmaceuticals (NASDAQ: TNXP) stands out as a biopharmaceutical company with a razor-thin float of less than 3 Mln shares, primed for significant volatility and price movements. The recent 59% surge, surpassing its 5-day moving average, underscores growing market recognition and excitement.    With a robust portfolio of innovative therapeutic developments targeting critical unmet needs, including CNS disorders, immunology, and infectious diseases, Tonix is paving the way for groundbreaking treatments.    The promising clinical results of Tonmya™ (TNX-102 SL) in Phase 3 trials and its upcoming NDA submission to the FDA in 2024 highlight the potential for impactful advancements in fibromyalgia treatment.    The exploration of TNX-102 SL for additional conditions like acute stress reactions and fibromyalgia-type Long CVD further broadens its therapeutic scope.   The FDA Breakthrough Therapy designation for TNX-1300 for treating co-caine intoxication signifies its critical role in addressing public health issues.    The landmark $34 Mln contract from the Defense Threat Reduction Agency (DTRA) for developing TNX-4200, a broad-spectrum antiviral, underscores the strategic significance of Tonix's research in national defense.   Tonix Pharmaceuticals (NASDAQ: TNXP) is at the forefront of biopharmaceutical innovation, poised to make substantial contributions to medical science and patient care.    With its strategic focus, advanced research capabilities, and commitment to addressing unmet medical needs, the company is set to redefine the landscape of biopharmaceutical development, promising a future filled with groundbreaking advancements and impactful therapies.   Immediately start your research on Tonix Pharmaceuticals (NASDAQ: TNXP) and keep a close eye on it this morning. Sincerely,   Jeff Ackerman Managing Editor, Stock News Trends StockNewsTrends (stocknewstrends . com) is owned by TD Media LLC, a limited liability company. Disclosure: I am not a fin-an-cial adviser. All potential percentage gains are based on from the low to the high of day. StockNewsTrends full disclosure is to be read and fully understood before using StockNewsTrends website, or joining StockNewsTrends' email or text list. 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