Company Website | Recent News ========================
Members,
We ask that you give your full attention to our new low-float Nasdaq listed alert TNXP (Tonix Pharmaceuticals Holding Corp.). TNXP is a clinical-stage biopharmaceutical company focused on discovering and developing pharmaceutical products to treat psychiatric and pain conditions, and biological products to improve biodefense through potential medical counter-measures. Tonix’s lead program is for the development of Tonmya** (TNX-102 SL), which is in Phase 3 development as a bedtime treatment for PTSD.
PTSD is a serious chronic psychiatric illness defined as a maladaptive prolonged stress response which occurs after experiencing severely injurious traumatic event(s). While initially recognized as a stress response to military combat ('shell shock') it is now known that many civilians exposed to life-threatening events, sexual assault, natural disasters or accidents, can develop PTSD.
According to the latest report published by Credence Research, Inc. the global post-traumatic stress disorder therapeutics market is projected to reach US 10.679M by 2026, expanding at a CAGR of 4.5% from 2018 to 2026.
TNXP Has the Potential to Be the Biggest Gainer On the Nasdaq
With its low-float of 4.74M, TNXP is no stranger to massive single-day run-ups.
Take a look at these past single-session gains:
3/14 $2.58 to $3.24 for gains of +25.58%
3/11 $2.80 to $4.12 for gains of +47.14%
3/8 $2.14 to $4.20 for gains of +96.26%
12/7 $3.15 to $7.24 for gains of +129.84%
TNXP also has several bullish catalysts on the horizon:
Chart has recently formed a "Golden Cross" which generally signals an uptrend. Roth Capital analyst Scott Henry upgraded TNXP from Neutral to Buy with a price target of $4.00. The Company will be presenting pharmacokinetic analyses of TNX-102 SL* in a poster at the American Society of Clinical Psychopharmacology (ASCP) 2019 Annual Meeting. Research has shown that PSTD treatment is not just for soldiers: Civilians with PTSD struggle to find effective therapy About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical company focused on discovering and developing pharmaceutical products to treat psychiatric and pain conditions, and biological products to improve biodefense through potential medical counter-measures. Tonix’s lead program is for the development of Tonmya** (TNX-102 SL), which is in Phase 3 development as a bedtime treatment for PTSD. Tonix is also developing TNX-102 SL as a bedtime treatment for fibromyalgia and agitation in Alzheimer’s disease under separate INDs to support potential pivotal efficacy studies. The fibromyalgia program is in Phase 3 development and the agitation in Alzheimer’s program is Phase 2 ready. The agitation in Alzheimer’s disease IND has been designated a Fast Track development program by the FDA. TNX-601 (tianeptine oxalate) is in the pre-IND application stage, also for the treatment of PTSD but by a different mechanism from TNX-102 SL and designed for daytime dosing. TNX-601 is also in development for a potential indication - neurocognitive dysfunction associated with corticosteroid use. A Phase 1 clinical formulation selection pharmacokinetic study of TNX-601 will be conducted outside of the U.S. in 2019. Tonix’s lead biologic candidate, TNX-801, is a potential smallpox-preventing vaccine based on a live synthetic version of horsepox virus, currently in the pre-IND application stage.
* TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.
**Tonmya has been conditionally accepted by the U.S. Food and Drug Administration (FDA) as the proposed trade name for TNX-102 SL for the treatment of PTSD.
This press release and further information about Tonix can be found at tonixpharma.com.
Company Highlights:
Phase 3 development of new bedtime treatment for PTSD, including military related PTSD
Major unmet need; ~12 million Americans annually Benefited from FDA 505(b)(2) NDA approval requirement Complimentary day-time PTSD treatment in development
Leverages development expertise in PTSD, i.e., regulatory, trial recruitment and execution Fibromyalgia bedtime treatment in development
New Phase 3 study design features discussed with FDA (April 2019 FDA Meeting Minutes) TNX-102 SL 5.6 mg (twice the dose previously studied in FM Phase 2/3 trials) will be studied in Phase 3 to support the indication New indication in development for agitation in Alzheimer’s Disease
Unmet medical need, no approved drug available Fast Track Phase 2/3 ready program Innovative vaccine in development to prevent Smallpox
Opportunity to supply stockpiling requirement; short development path Studies in mice suggest improved safety profile Recently Completed Milestones
July 2018 Completed P301/HONOR study interim analysis - result did not support study continuation but strengthened new Phase 3 study August 2018 Presentation of P301/HONOR study results at Military Health System Scientific Symposium October 2018 Met with FDA and received preliminary agreement on the design of new Phase 3 study of Tonmya for PTSD (P302/RECOVERY study) November 2018 Received FDA minutes confirming agreement on the design of P302/RECOVERY study March 2019 Met with FDA to discuss new FM Phase 3 study design using TNX-102 SL 5.6 mg March 2019 P302/RECOVERY study initiated April 2019 Received FDA formal minutes with clear guidance and support on new Phase 3 FM study Upcoming Milestones
Second Half 2019 Preliminary human pharmacokinetic and safety data (non-IND study) from selected TNX-601 (tianeptine oxalate) formulation expected First Half 2020 Topline data from P302/RECOVERY study expected Market Outlook
Globally, the vast majority of people (~70%) will experience or witness one or more life-threatening traumatic events in their life-time. For many, the response to an isolated traumatic event will dissipate over days or a few weeks and have little or no long-term consequences.
For some individuals, however, the response to trauma will become chronic, lasting for more than one month and persisting for years, and, in many cases, decades. These individuals are considered to have PTSD and will experience psychiatric symptoms (flashbacks, intense anxiety and avoidance, emotional numbness, intense guilt or worry, agitation, sleep disturbances), and as a consequence, experience impaired social functioning, occupational disability, and an overall poor quality of life. PTSD is also characterized by overall high utilization of healthcare services, adding to the significant economic burden from the condition.
How prevalent is PTSD?
PTSD is a global problem, with the lifetime prevalence of PTSD estimated to be 3.9%, or affecting an estimated 200-300 million individuals, on a global basis.
Based on U.S. 12-month prevalence rates,1,2 it is estimated that about 11.0 million American adults suffer from DSM-5-defined PTSD in a given year. Similar to other psychiatric disorders, only approximately half of these individuals will seek treatment at some point in the course of the disease, and of these, approximately 40% (~1.8 million) will be formally diagnosed with PTSD in any given year. Lack of awareness, the negative stigma associated with PTSD (like other mental disorders), as well as the limitations of existing treatment options, may be addressed by increased societal awareness and acceptance as well as the introduction of new therapeutic options.
Technical Analysis
As we stated above, with its low-float of 4.74M, TNXP is no stranger to massive single-day run-ups.
TNXP's chart has recently formed a "Golden Cross" which generally signals an uptrend.
We've done our very own chart analysis, and see the potential for a move of over +27%!
The Bottom Line
We are extremely bullish on TNXP.
Based on our research we believe that this could be the biggest single-day gainer on the Nasdaq today.
That being said, we ask that you start your research on TNXP immediately and consider building a position this morning at 9:30AM EST
(*Remember to use a Stop-Loss Order or basic Limit Order to protect your gains, as well as limit possible losses.)
Best Regards,
The TopMarketGainers Team
Don't Miss Our Next Huge Winner... Text 'GAINS' to '67076' to have our Trade Alerts Delivered Direct to your Cell Phone. (There is no charge.
Msg&data rates may apply.)
DISCLAIMER
This newsletter is a paid advertisement, not a recommendation nor an offer to buy or sell securities. This newsletter is owned, operated and edited by both MJ Capital, LLC and PennyStockLocks, LLC. Any wording found in this e-mail or disclaimer referencing to “I” or “we” or “our” refers to MJ Capital, LLC and PennyStockLocks, LLC. Our business model is to be financially compensated to market and promote small public companies. By reading our newsletter and our website you agree to the terms of our disclaimer, which are subject to change at any time. We are not registered or licensed in any jurisdiction whatsoever to provide investing advice or anything of an advisory or consultancy nature, and are therefore are unqualified to give investment recommendations. Always do your own research and consult with a licensed investment professional before investing. This communication is never to be used as the basis of making investment decisions, and is for entertainment purposes only. At most, this communication should serve only as a starting point to do your own research and consult with a licensed professional regarding the companies profiled and discussed. Conduct your own research. Companies with low price per share are speculative and carry a high degree of risk, so only invest what you can afford to lose. By using our service you agree not to hold our site, its editor’s, owners, or staff liable for any damages, financial or otherwise, that may occur due to any action you may take based on the information contained within our newsletters or on our website.
We do not advise any reader take any specific action. Losses can be larger than expected if the company experiences any problems with liquidity or wide spreads. Our website and newsletter are for entertainment purposes only. Never invest purely based on our alerts. Gains mentioned in our newsletter and on our website may be based on end-of-day or intraday data. This publication and their owners and affiliates may hold positions in the securities mentioned in our alerts, which we may sell at any time without notice to our subscribers, which may have a negative impact on share prices. If we own any shares we will list the information relevant to the stock and number of shares here. MJ Capital does NOT own any shares of the companies mentioned herewithin, nor intends to buy any in the future.
MJ Capital’s business model is to receive financial compensation to promote public companies. We have NOTbeen compensated to conduct investor relations advertising and marketing for TNXP. Any compensation is a major conflict of interest in our ability to be unbiased. Therefore, this communication should be viewed as a commercial advertisement only. We have not investigated the background of the hiring third party or parties. The third party, profiled company, or their affiliates likely wish to liquidate shares of the profiled company at or near the time you receive this communication, which has the potential to hurt share prices. Any non-compensated alerts are purely for the purpose of expanding our database for the benefit of our future financially compensated investor relations efforts. Frequently companies profiled in our alerts may experience a large increase in volume and share price during the course of investor relations marketing, which may end as soon as the investor relations marketing ceases. The investor relations marketing may be as brief as one day, after which a large decrease in volume and share price is likely to occur. Our emails may contain forward looking statements, which are not guaranteed to materialize due to a variety of factors.
We do not guarantee the timeliness, accuracy, or completeness of the information on our site or in our newsletters. The information in our email newsletters and on our website is believed to be accurate and correct, but has not been independently verified and is not guaranteed to be correct. The information is collected from public sources, such as the profiled company’s website and press releases, but is not researched or verified in any way whatsoever to ensure the publicly available information is correct. Furthermore, MJ Capital often employs independent contractor writers who may make errors when researching information and preparing these communications regarding profiled companies. Independent writers’ works are double-checked and verified before publication, but it is certainly possible for errors or omissions to take place during editing of independent contractor writer’s communications regarding the profiled company(s). You should assume all information in all of our communications is incorrect until you personally verify the information, and again are encouraged to never invest based on the information contained in our written communications. The information in our disclaimers is subject to change at any time without notice.
Comment
⋅
Update: TNXP gearing up for an afternoon rally. Next stop $2.00 [Details Inside]