Monday 7 October 2024

FDA Fast-Track: Tonix Pharmaceuticals (Nasdaq: TNXP) Needs to be on Your Watchlist Tomorrow After Triggering 14 Bullish Signals Today

Market Crux: Exclusive Profile Just Announced!


Tonix Pharmaceuticals (Nasdaq: TNXP) Needs to be on Your Watchlist 

Tomorrow Morning!


Oragenics, Inc. (NYSE American: OGEN) Comes Stacked with Several Potential Catalysts Including: 


Recent Market Recognition: Tonix Pharmaceuticals (Nasdaq: TNXP) saw a 30% move in one week, triggering 14 bullish signals on TradingView, indicating the potential for continued momentum!


Analyst Coverage: Alliance Global Partners’ James Molloy raised his target on Tonix Pharmaceuticals to $11, signaling confidence with a potential upside of over 7,825%!


FDA Fast-Track: TNX-102 SL received Fast Track designation from the FDA for fibromyalgia treatment, acknowledging its potential to address a significant unmet need!


Non-Opioid Pain Management: TNX-102 SL offers an innovative, non-opioid solution for chronic pain, potentially transforming treatment options for millions of fibromyalgia patients!


Diverse Product Pipeline: Tonix’s portfolio covers CNS disorders, rare diseases, and infectious diseases, reflecting the company’s broad focus on critical health issues!


Regulatory Milestones: An NDA submission for TNX-102 SL is expected in October 2024, marking a pivotal point in the company’s product approval process!


Patent Strength: Recent patents for TNX-102 SL and migraine treatments secure intellectual property rights and bolster Tonix’s competitive position in major markets!


Make Sure Tonix Pharmaceuticals (Nasdaq: TNXP) is on Your Radar!







October 7, 2024



Dear Reader,


Last week’s profiles saw approximate moves of 106% in total, making it the perfect time to shift focus to the Biopharmaceutical sector.


Few sectors in the market see small companies go from having tiny market caps to being worth many times more practically overnight. The industry of curing diseases can be a lucrative one, and many will jump on the bandwagon for any company that shows the promise of a big breakthrough


That’s why you need to see what we just uncovered.


With Fast Track designation granted by the FDA, Tonix Pharmaceuticals (Nasdaq: TNXP) needs to be on your watchlist early tomorrow morning.

Tonix Pharmaceuticals (Nasdaq: TNXP) is a biopharmaceutical company pioneering a range of innovative solutions for pain management, with a particular focus on central nervous system (CNS) disorders. 


The company has gained attention for its forward-thinking approach to addressing public health challenges, particularly in the management of chronic pain and other CNS-related issues. 


Tonix Pharmaceuticals (Nasdaq: TNXP) just moved approximately 30% in around a week, surpassing its 5-day and 20-day moving averages.  As of around 2 PM EST today, TradingView’s technical analysis tool using the 15-minute time frame triggered 14 Bullish Signals, indicating the potential for continued momentum. 


Recently, Tonix Pharmaceuticals (Nasdaq: TNXP) garnered the attention of analyst James Molloy from Alliance Global Partners. 


As reported by Benzinga on 7/22, Molloy raised his target price for the company from $6 to $11, maintaining a bullish outlook on its future. 


This revised target represents a potential upside of over 7,825% from today’s opening of around $.1388, signaling strong confidence in the company's growth potential and its innovative pipeline.

Tonix Pharmaceuticals (Nasdaq: TNXP)’s leading product candidate, TNX-102 SL, is poised to reshape chronic pain treatment for fibromyalgia, a prevalent condition that has long lacked effective treatment options. 



With Fast Track designation granted by the FDA and a New Dr-ug Application (NDA) submission planned for October 2024, Tonix Pharmaceuticals (Nasdaq: TNXP) is positioning itself as a player in the development of non-opioid pain management solutions.


TNX-102 SL and Fibromyalgia: A Breakthrough in Pain Management

Fibromyalgia, a chronic pain disorder affecting around 10M Americans, is notoriously difficult to treat due to the complexity of its symptoms. 


Traditional therapies, including opioids, have proven inadequate in providing long-term relief, often leading to issues like addiction and misuse. 


TNX-102 SL, a sublingual formulation of cyclobenzaprine hydrochloride, represents a potential paradigm shift in fibromyalgia treatment. 


Unlike conventional therapies, TNX-102 SL specifically targets sleep disturbances associated with fibromyalgia, offering a new mechanism of action that aims to alleviate pain by improving sleep quality.


Two statistically significant Phase 3 studies have already demonstrated TNX-102 SL’s efficacy in reducing daily pain and improving other key fibromyalgia symptoms, such as fatigue and sleep disruption. 


With the NDA submission set for October 2024 and a potential FDA decision expected in 2025 under the Prescription Dr-ug User Fee Act (PDUFA), TNX-102 SL could become the first new treatment for fibromyalgia in over 15 years.


Broad-Spectrum CNS Solutions

Tonix Pharmaceuticals (Nasdaq: TNXP)’s pipeline extends beyond fibromyalgia, covering a range of CNS disorders and public health challenges. The company’s portfolio includes TNX-1300, a biologic designed to treat co-ca-ine intoxication. 


With Breakthrough Therapy designation from the FDA, TNX-1300 is currently in Phase 2 development and holds promise for addressing an often-overlooked aspect of substance abuse treatment.


Another key candidate, TNX-1500, is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154), which is being developed for the prevention of organ transplant rejection and the treatment of autoimmune diseases. 


This expansion into immunology highlights Tonix’s commitment to tackling a wide spectrum of critical health issues.


Innovative Solutions for Rare Diseases and Infectious Threats

In addition to CNS and immunology therapies, Tonix Pharmaceuticals (Nasdaq: TNXP) is advancing treatments for rare diseases and infectious diseases. TNX-2900, aimed at treating Prader-Willi syndrome, is one of the company’s rare disease product candidates. 


The company is also developing TNX-801, a vaccine targeting MPX.


Tonix’s expertise in infectious diseases has been further validated by the U.S. Department of Defense’s (DoD) recent $34M contract awarded to the company to develop TNX-4200. 


This small-molecule antiviral agent is intended to protect military personnel from biological threats, demonstrating Tonix Pharmaceuticals (Nasdaq: TNXP)’s capacity to address not only chronic and rare diseases but also pressing global health issues.


Patents and Intellectual Property: Securing the Future


Tonix Pharmaceuticals (Nasdaq: TNXP)’s leadership in pain management and CNS therapies is reinforced by its growing intellectual property portfolio. 


In September 2024, the company announced the issuance of U.S. Patent No. 12,090,139, covering the intranasal delivery of Tosymra®, a sumatriptan nasal spray for migraines. 


This patent, expected to provide protection until 2030, strengthens Tonix Pharmaceuticals (Nasdaq: TNXP)’s position in the migraine treatment market. Tosymra® is marketed through Tonix’s subsidiary, Tonix Medicines, along with Zembrace® SymTouch®, a sumatriptan injection for migraines.


Additionally, Tonix Pharmaceuticals (Nasdaq: TNXP) has secured patents for TNX-102 SL’s eutectic composition, ensuring market exclusivity for the fibromyalgia treatment in the U.S., E.U., Japan, China, and other jurisdictions until at least 2034. 


These developments strengthen Tonix Pharmaceuticals (Nasdaq: TNXP)’s position in critical markets and safeguard its innovative formulations from competition.


Tonix Pharmaceuticals (Nasdaq: TNXP)’s Role in the Shift Toward Non-Addictive Pain Management


As the opioid crisis continues to ravage communities, there is a growing demand for non-addictive pain treatments. 


Tonix Pharmaceuticals (Nasdaq: TNXP) is aiming to play a role in this movement with TNX-102 SL, which offers a new, non-opioid option for chronic pain management.


By targeting the underlying sleep disturbances that exacerbate fibromyalgia pain, TNX-102 SL could provide a safer, more effective alternative to opioids.


This emphasis on non-addictive pain relief aligns with broader industry trends, such as the FDA’s recent priority review of Vertex Pharmaceuticals’ VX-548, a non-opioid dr-ug for acute pain. 


Tonix Pharmaceuticals (Nasdaq: TNXP)  and Vertex are part of a larger effort to revolutionize pain management by offering alternatives that reduce the risks of addiction and misuse.


Tonix Pharmaceuticals (Nasdaq: TNXP)  is at a pivotal moment, with several high-potential treatments nearing critical regulatory milestones. TNX-102 SL’s NDA submission in October 2024 marks a significant step toward addressing the unmet needs of fibromyalgia patients. With a robust portfolio covering CNS disorders, rare diseases, and infectious threats, Tonix is positioned to reshape chronic pain treatment and provide innovative solutions for other public health challenges.


As the healthcare landscape continues to evolve, Tonix Pharmaceuticals (Nasdaq: TNXP)’s commitment to developing non-addictive, next-generation therapies could significantly impact the future of pain management and beyond. If successful, TNX-102 SL could become a breakthrough treatment, offering new hope to mil-lions of patients suffering from fibromyalgia and other chronic pain conditions.


7 reasons why Tonix Pharmaceuticals (Nasdaq: TNXP) needs to be on your watchlist tomorrow morning…


1. Recent Market Recognition: Tonix Pharmaceuticals (Nasdaq: TNXP) recently saw an approximate 30%  move in just one week, triggered 14 bullish signals on TradingView’s technical analysis tool, signaling the potential for continued bullish momentum. 

 

2. Analyst Coverage: Alliance Global Partners’ analyst James Molloy raised his target on Tonix Pharmaceuticals (Nasdaq: TNXP) to $11, representing a significant shift in confidence and suggesting over 7,825% in potential upside from today’s price levels.


3. FDA Fast-Track Designation: Tonix Pharmaceuticals (Nasdaq: TNXP)’s TNX-102 SL has received Fast Track designation for fibromyalgia treatment, showing the FDA's recognition of its potential to address a critical unmet need in chronic pain management.


4. Innovative Pain Management Solutions: TNX-102 SL offers a non-opioid approach to chronic pain management, potentially revolutionizing treatment options for mil-lions of fibromyalgia patients.


5. Pipeline Diversity: Beyond fibromyalgia, Tonix Pharmaceuticals (Nasdaq: TNXP) has a diverse product portfolio that spans central nervous system disorders, rare diseases, and infectious disease therapies, showcasing their broad reach in key health areas.


6. Upcoming Regulatory Milestones: With an NDA submission expected in October 2024 for TNX-102 SL, Tonix Pharmaceuticals (Nasdaq: TNXP) is nearing a critical juncture in its product approval process, which could reshape the chronic pain treatment landscape.


7. New Patents Strengthen Position: Recent patents for TNX-102 SL and migraine treatments secure Tonix Pharmaceuticals (Nasdaq: TNXP)’s intellectual property rights and enhance its ability to compete in major pharmaceutical markets, safeguarding its innovations.


Tonix Pharmaceuticals (Nasdaq: TNXP) has gained attention recently with an approximate 30% move over the past week, coupled with the 14 Bullish Signals triggered today on TradingView. Analyst James Molloy’s target increase to $11 highlights increasing optimism about the company's future. With the FDA Fast Track designation for TNX-102 SL and a wide-ranging pipeline focusing on important health areas, Tonix Pharmaceuticals (Nasdaq: TNXP) is nearing a significant milestone, with an NDA submission anticipated in October 2024. 


Additionally, recent patent achievements have strengthened its position in the market. As Tonix Pharmaceuticals (Nasdaq: TNXP) advances its efforts in pain management and other therapeutic areas, it remains an important contender in the biopharmaceutical industry.


Tonix Pharmaceuticals (Nasdaq: TNXP) needs to be on your radar this week.


(TNXP) is trending near or above its 5-day and 20-day moving averages.


Make no mistake.


Put Tonix Pharmaceuticals (Nasdaq: TNXP) at the top of your watchlist tomorrow.


I’ll check back in with you in the morning.


Have a good night.

Sincerely,


Gary Silver

Managing Editor,

MarketCrux

MarketCrux (MarketCrux . com) is owned by Headline Media LLC, a limited liability company. Disclosure: I am not a lice.nsed finan.cial adviser. Make sure to always do your own research and due diligence on any day and swing profile I bring to your attention. MarketCrux full disclosure is to be read and fully understood before using MarketCrux website, or joining MarketCrux's email or text list. By viewing MarketCrux website and/or reading MarketCrux email or text newsletter you are agreeing to MarketCrux full disclosure which can be read at marketcrux.com/disclaimer


Pursuant to an agreement between Headline Media LLC and TD Media LLC, Headline Media LLC has been hired by TD Media LLC for a period beginning on 10/07/2024 and ending on 10/08/2024 to publicly disseminate information about (TNXP:US) via digital communications. Under this agreement, Headline Media LLC has been paid seven thousand five hundred USD (“Funds”) to disseminate information about (TNXP:US) via digital communications. To date Headline Media LLC has been paid fifteen thousand USD (“Funds”). These Funds were part of the funds that TD Media, LLC received from a third party who does not own stock in the issuer. Headline Media LLC, is a Florida limited liability company whose co-members are the single member of TD Media LLC (the “Control Member”) and an employee of TD Media LLC. Neither Headline Media LLC, TD Media LLC and their members own shares of (TNXP:US). Please see important disclosure information here: https://marketcrux.com/tnxp-disclosure-7894/

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