Breaking News: Tonix Pharmaceuticals (NASDAQ: TNXP) Makes Approx 15% Early Move After Positive Phase 1 Trial Results

*Sponsored Just Announced! Tonix Pharmaceuticals (NASDAQ: TNXP) is Our Next Potential Breakout Idea For Thursday Morning! And Here’s Why… Low Float: Recent Reverse Split Leaves Under 2M Shares and  Market Cap Under $28M. Promising Product Pipeline: Developing Treatments for High-Need Conditions with Limited Options. Fast-Tracked Treatment for Fibromyalgia: FDA Fast Track  Designation for TNX-102 SL. Path to FDA Approval: Key Regulatory Milestones Ahead for TNX-102 SL. Keep Reading To See Why Tonix Pharmaceuticals (NASDAQ: TNXP) is Topping Our Pre-Market Watchlist This Morning... February 6, 2025 Dear Reader, Please tell me you’re watching Tonix Pharmaceuticals (NASDAQ: TNXP) right now. Tonix Pharmaceuticals (NASDAQ: TNXP) has made an early splash in the pre-market, moving approximately 15% to $17.35 after announcing positive topline results from its Phase 1 trial of TNX-1500, a next-generation anti-CD40L monoclonal antibody designed to prevent kidney transplant rejection and treat autoimmune diseases.  The trial showed that TNX-1500 successfully blocked antibody responses and demonstrated a long half-life, supporting monthly dosing in future trials.   With this impressive data, (TNXP) is on track to begin Phase 2 trials, and people are taking notice. In fact, after a recent reverse split earlier this week, Tonix Pharmaceuticals (NASDAQ: TNXP) now has just 2M shares in its float and a market cap under $28M.  With such a low float, (TNXP) has the potential to experience significant price swings if demand begins to shift, making it especially attractive to those who thrive on volatility.  When combined with its promising pipeline, Tonix Pharmaceuticals (NASDAQ: TNXP) could have a higher potential for growth compared to larger companies in the space. Now let’s dive into why Tonix Pharmaceuticals (NASDAQ: TNXP) is topping our watchlist tomorrow morning. Tonix Pharmaceuticals (NASDAQ: TNXP) is a company that has positioned itself at the forefront of addressing some of the most challenging and underserved areas of healthcare.  While the company may not be as widely recognized as some of its larger biotech counterparts, Tonix Pharmaceuticals (NASDAQ: TNXP) is making significant strides in developing treatments for conditions that impact a large number of people, including fibromyalgia, co-ca-ine intoxication, and rare diseases like Prader-Willi Syndrome. A Focused Portfolio with High Unmet Needs Tonix Pharmaceuticals (NASDAQ: TNXP)’s research and development efforts are concentrated on several key therapeutic areas, particularly within the world of Central Nervous System (CNS) disorders.  Here's a look at some of their most promising candidates: TNX-102 SL (Sublingual Cyclobenzaprine): This treatment is targeting fibromyalgia, a chronic pain disorder that significantly impacts the quality of life for many individuals. What sets TNX-102 SL apart is its unique sublingual formulation, designed to be absorbed quickly into the bloodstream, bypassing the liver's first-pass metabolism. This method could potentially reduce side effects commonly associated with traditional oral cyclobenzaprine formulations.  Given the limitations of current treatments for fibromyalgia, TNX-102 SL holds great promise for those suffering from this condition. Status: The dr-ug is advancing rapidly through clinical trials. Tonix received FDA Fast Track Designation in 2024 and submitted its New Application (NDA) in October 2024.  With a Prescription User Fee Act (PDUFA) goal date set for August 15, 2025, the company is now awaiting regulatory approval. TNX-1300 (Co-ca-ine Esterase): With this product, Tonix aims to address co-ca-ine intoxication by developing an enzyme-based treatment that neutralizes the dr-ug in the bloodstream.  Funded by the National Institute on Dr-ug Abuse (NIDA), TNX-1300 is a promising therapeutic option for an often-overlooked medical emergency. TNX-2900 (Intranasal Potentiated Ox-yto-cin): Targeting Prader-Willi Syndrome, this investigational dr-ug could have a profound impact on a rare genetic disorder that causes severe hunger and developmental challenges.  The FDA has already granted Orphan and Rare Pediatric Disease Designations to TNX-2900, further underscoring its potential. TNX-1500 (Anti-CD40L Monoclonal Antibody): Tonix is also exploring treatments for organ transplant rejection and autoimmune conditions.  TNX-1500 is designed to prevent the immune system from attacking transplanted organs, which could revolutionize the management of transplant recipients. The Fibromyalgia Market: A Major Unmet Need Fibromyalgia is a condition affecting over 10M adults in the U.S. alone, and while there are FDA-approved treatments, these options are far from perfect.  The existing therapies often come with significant side effects, and up to 85% of patients fail to find success with first-line treatments. This creates a significant need for a more effective solution. TNX-102 SL, Tonix’s sublingual cyclobenzaprine, aims to address this gap by offering a treatment option that could target pain, sleep disturbances, and fatigue—the three hallmark symptoms of fibromyalgia—without the drawbacks of current therapies.  In their recent pivotal Phase 3 RESILIENT study, Tonix showed a statistically significant reduction in daily pain compared to a placebo, a result that could position TNX-102 SL as a breakthrough in the treatment of fibromyalgia. The Science Behind TNX-102 SL: Innovative Delivery, Enhanced Efficacy Why is Tonix so confident in TNX-102 SL?  The answer lies in its sublingual formulation, which allows the dr-ug to bypass the liver’s first-pass metabolism and enter the bloodstream more efficiently.  This results in faster absorption and potentially fewer side effects compared to oral treatments, which undergo metabolism in the liver and can generate persistent metabolites like norCBP that may cause unwanted side effects. By leveraging a patent-protected eutectic formulation, Tonix has designed a product that promises to deliver the therapeutic effects of cyclobenzaprine more effectively, particularly for individuals who need a non-opioid analgesic.  This innovative approach could significantly improve treatment adherence and patient outcomes. Looking Ahead: The Path Forward for Tonix Pharmaceuticals Tonix Pharmaceuticals has carved out a niche for itself with a clear focus on developing novel treatments for high-need areas, especially in the CNS space.  Their pipeline of promising dr-ug candidates—backed by rigorous clinical trials and the support of government funding—positions them well for future success.  While the road to approval is never guaranteed, Tonix’s innovative approach to treating chronic conditions like fibromyalgia and rare diseases makes them a company worth watching. With key regulatory milestones ahead, including the FDA’s decision on TNX-102 SL expected by August 2025, the coming months could prove pivotal for Tonix.   If their dr-ugs meet the rigorous standards of the FDA, Tonix Pharmaceuticals may very well become a leading player in the biotech space, offering new hope to patients in desperate need of better treatment options. 7 Reasons Why Tonix Pharmaceuticals (NASDAQ: TNXP) is Topping Our Pre-Market Watchlist… 1. Low Float: After a reverse split, (TNXP) now has under 2M shares in its float and a market cap under $28M, suggesting potential for significant price movements if demand shifts. 2. Promising Product Pipeline: (TNXP) is developing treatments for high-need conditions with limited options, positioning the company as a leader in underserved markets. 3. Fast-Tracked Treatment for Fibromyalgia: (TNXP)’s TNX-102 SL is advancing rapidly through clinical trials for fibromyalgia, with FDA Fast Track Designation and a PDUFA goal date of August 15, 2025. 4. Innovative Approach to Delivery: TNX-102 SL uses a sublingual delivery method, bypassing the liver's metabolism, offering faster absorption and fewer side effects compared to oral treatments. 5. Strategic Focus on Rare and Underserved Diseases: (TNXP) is targeting rare conditions like Prader-Willi Syndrome and co-ca-ine intoxication, positioning it for growth in low-competition markets. 6. Government Support: (TNXP) has received funding from the National Institute on Dr-ug Abuse (NIDA) for its TNX-1300 enzyme treatment, showcasing strong government backing. 7. Path to FDA Approval: With key regulatory decisions ahead, including the FDA review of TNX-102 SL, (TNXP) could see its treatments approved and ready for market, driving future growth. Consider Adding Tonix Pharmaceuticals (NASDAQ: TNXP) To  Your Radar This Week… Tonix Pharmaceuticals (NASDAQ: TNXP) is a company to keep an eye on as it moves forward with a promising pipeline, a low float that could lead to significant swings, and FDA fast-track status for its treatments.  With a focus on rare, underserved diseases and strong government backing, Tonix is well-positioned to make strides in the healthcare space.  We have all eyes on (TNXP) right now.  Tonix Pharmaceuticals (NASDAQ: TNXP) has made an early splash in the pre-market, moving approximately 15% to $17.35 after announcing positive topline results from its Phase 1 trial of TNX-1500. Are you watching yet?  Keep a lookout for my next update. Sincerely, Jeff Ackerman Managing Editor Stock News Trends StockNewsTrends.com (“StockNewsTrends” or “SNT” ) is owned by TD Media LLC, a single member limited liability company. 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Under this agreement, TD Media LLC has been paid twelve thousand five hundred USD (“Funds”). To date, including under the previously described agreement, TD Media LLC has been paid sixty-nine thousand five hundred USD (“Funds”). These Funds were part of the funds that TD Media LLC received from a third party who did receive the funds from the issuer and does not own stock in the issuer but the reader should assume that the clients of the third party own shares in the issuer that they will liquidate at or near the time you receive this communication, which has the potential to hurt share prices. Neither TD Media LLC or its member owns shares of (TNXP:US). Please see important disclosure information here: https://lifewatermedia.com/disclosure/tnxp/#details 

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