This Nasdaq Stock And The FDA!

Tomorrow's Alert: (NASDAQ:TNXP)   TNXP Is a biotech stock with BULLish ratings, promising developments, and potential FDA greenlights in its near future! Greetings Investors, The exciting world of biotech is home to many big companies and many promising small-cap companies that could be around the corner from FDA green lights, commercialization, major breakthroughs, and other exciting developments that could launch them into Wall Street's spotlight. On that note, hurry and add Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) to your radar! TNXP is a fully-integrated biopharmaceutical company focused on developing, licensing, and commercializing therapeutics to treat and prevent human disease and alleviate suffering. There are several immediate reasons to have TNXP on your watch list.  Trading at mere pennies, TNXP currently has a "STAY LONG" rating at AmericanBulls.com and a consensus "STRONG BUY" rating at NASDAQ.com. Research firms covering the stock include: ALLIANCE GLOBAL NOBLE FINANCIAL ZACKS SMALL CAP   Analyst Price Targets? THE CONSENSUS IS $2.25!!  The stock is currently trading at under 20 cents! Based on analysts offering 12-month price targets for TNXP in the last 3 months. The average price target is $2.25 with a high estimate of $3 and a low estimate of $1.5.  You can see more HERE. Why are analysts so bullish on TNXP? Maybe because the company is on track to submit NDA in the second half of 2024 for Tonmya™ for fibromyalgia, A pre-NDA meeting with the FDA is scheduled for second quarter 2024! Tonmya is the trade name for TNX-102, which is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Commercial planning continues for U.S. launch of Tonmya, a potential new first-line, centrally-acting, non-opioid analgesic for the management of fibromyalgia. "Our near-term priority continues to be the submission of our New Drug Application (NDA) for Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia, while continuing to build out our commercial strategy for the anticipated product launch in the event of FDA approval, which we currently estimate to occur in the second half of 2025," said Seth Lederman, M.D., Chief Executive Officer of TNXP. Dr. Lederman added, "The well-known treatment-limiting side effects of the three currently approved drugs have led to widespread patient dissatisfaction, creating what we believe is a significant opportunity for a new therapeutic. Tonmya has a differentiated mechanism of action and is generally free of common side effects associated with the currently approved products, including weight gain, fatigue, insomnia, increased blood pressure, gastrointestinal issues or sexual dysfunction. As such, we believe Tonmya, if approved, could become the treatment of choice for the approximately 10 million people in the U.S. suffering the debilitating effects of fibromyalgia." This is an exciting time to have the company at your attention with this FDA meeting around the corner. Earlier this year TNXP had exciting FDA news about its TNX-2900* (intranasal potentiated oxytocin), a proprietary magnesium (Mg2+)-potentiated formulation of intranasal oxytocin, to treat Prader-Willi syndrome (PWS) in children and adolescents. The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to TNX-2900*. It was previously granted Orphan Drug designation by the FDA in 2022 for the treatment of PWS and the investigational new drug (IND) application was cleared by the FDA in 2023. The Company may be eligible to receive a transferable Priority Review Voucher if TNX-2900 for PWS is approved for marketing. Recently, vouchers have sold for approximately $100 million! More on the Company: TNXP's development portfolio is focused on central nervous system (CNS) disorders.  Tonix's CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix's immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases.  Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, 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. Make sure to check out the company's pipeline here: https://www.tonixpharma.com/pipeline-2/  In Summary… TNXP is a biotech company trading at pennies right now. Bullish ratings have piled up from analysts and there's a price target north of $2.00 on the stock! And to highlight, this is also a company with plenty of cash on hand for its exciting endeavors. As of March 31, 2024, Tonix had $7.0 million of cash and cash equivalents! There could be some big FDA news in TNXP's future so make sure to watch the company's news for developments and start your research! Disclaimer We are engaged in the business of advertising and promoting companies. All content on our website is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities. 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