📰 MONSTER FDA News just dropped on CTXR!

[View online]( [UNSUBSCRIBE]( NEW MOMENTUM STOCK: NASDAQ: CTXR With the markets rallying again and today's alert on CTXR firmly in the GREEN - adding fuel to the fire is some [BREAKING NEWS]( just this morning!! [Citius Pharmaceuticals, Inc. Submits Biologics License Application to the U.S. Food and Drug Administration for Denileukin Diftitox for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymphoma]( CRANFORD, N.J., Sept. 28, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for denileukin diftitox (I/ONTAK), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK®. The BLA is supported by a pivotal Phase 3 study (NCT01871727). Results of the study were consistent with the prior FDA-approved formulation. "The treatment of advanced cutaneous T-cell lymphoma remains a complex and challenging unmet medical need. Each year, thousands of patients are diagnosed with CTCL, a debilitating orphan disease with no single standard of care. Patients are often treated with multiple alternate therapies. Citius is proud to advance the only potential CTCL therapeutic with a mechanism of action that delivers a cytotoxic protein by binding to the IL-2 receptors found in malignant T-cells and immunosuppressive T-regulatory cells. We look forward to continuing to engage with the FDA as they review our BLA and bringing this treatment option to patients, if approved," stated Leonard Mazur, Chairman and CEO of Citius. "The BLA filing for denileukin diftitox marks the first of our pipeline candidates to be submitted for FDA approval." About I/ONTAK I/ONTAK is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK. ONTAK was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market. Manufacturing improvements resulted in a new formulation, which maintains the same amino acid sequence but features improved purity and bioactivity. The new formulation received regulatory approval in Japan in 2021 for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). In 2011 and 2013, the FDA granted orphan drug designation (ODD) to I/ONTAK for the treatment of PTCL and CTCL, respectively. About Cutaneous T-cell Lymphoma Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple systemic agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL. Approximately 3,000 new cases are reported in the United States every year, with an estimated 30,000 - 40,000 individuals living with the disease. Link to full press release: 2022 Was a Year of Major Catalysts for CTXR… a $1 Biotech Stock that has a $10 Price Target!  Greetings Investors, A big biotech comeback may be around the corner….  Many biotech stocks took a beating over the past 12 months, but their cheap valuations could be good entry points for investors. The outlook for biotech stocks is positive in part because the last time the market experienced a similar drawdown was during the 2015 to 2016 time period when the decline was about 50%. In the subsequent 23 months, biotech stocks “worked back to new highs and the sector was up over 130%, said [Thomas Hayes,]( chairman of Great Hill Capital in New York. This is the worst correction [in the biotech sector] I have seen in my 22-year career,” [Michele Gesualdi]( founder of London-based investment group Infinity Investment Partners, told the Financial Times. “We have never seen stress like this.” Gesualdi believed that the sector is, on all metrics, “as cheap as it has ever been.” While the opportunity is blazing, one emerging NASDAQ biotech company could be ripe for growth with a current share price around $1!  [2 analysts]( offering 12-month price forecasts have a median target of 7.00, with a high estimate of 10.00 and a low estimate of 4.00. (ALL higher than the current trading price!)  The company has TWO products with one receiving FAST TRACK designation from the FDA and the other receiving ORPHAN DRUG designation! With 5 diversified pipeline candidates, a staggering $26.5M invested by founders, $48M of cash on hand, and products addressing some of the world's most addressable markets, Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) may be positioned for incredible gains! [FULL REPORT ON NASDAQ: CTXR]( Copyright 2022 © MomentumStocks.io is 50% owned and operated by the owner of CareBear Marketing Group LLC. Disclaimer and Privacy For more Information please contact Support@MomentumStocks.io This website provides information about the stock market and other investments. This website does not provide investment advice and should not be used as a replacement for investment advice from a qualified professional. This website is for informational purposes only. The Author of this website is not a registered investment advisor and does not offer investment advice. You, the reader, bear responsibility for your own investment decisions and should seek the advice of a qualified securities professional before making any investment. Nothing on this website should be considered personalized financial advice. Any investments recommended here in should be made only after consulting with your personal investment advisor and only after performing your own research and due diligence, including reviewing the prospectus or financial statements of the issuer of any security. CareBear Marketing Group, its managers, its employees, affiliates, and assigns (collectively "The Company") do not make any guarantee or warranty about the advice provided on this website or what is otherwise advertised above. To the maximum extent permitted by law, the Company disclaims all liability in the event any information, commentary, analysis, opinions, advice and/or recommendations provided herein prove to be inaccurate, incomplete, or unreliable, or result in any investment or other losses. You received this message as part of your subscription to MomentumStocks.io (MS). MS is a free financial news and information website. We do not directly sell any products or offer any personal financial advice, nor do we advocate the purchase or sale of any security or investment for any specific individual. We also do not make any guarantee or warranty about what is advertised above. If you have questions or concerns about a product you’ve seen in one of our emails, we encourage you to reach out to that company directly. Disclaimer – 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. 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 CareBear Marketing Group. Any wording found in this e-mail or disclaimer referencing to “I” or “we” or “our” or “MS” refers to CareBear Marketing Group. 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 unqualified to give investment recommendations. Companies with low prices 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 to 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 its 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 the number of shares here. We do not own any shares in CTXR. We have been currently compensated up to Seventy-Five Thousand Dollars Cash ($75,000) via bank wire transfer from a third-party Legends Media for a 4 Day Marketing Program regarding CTXR with a start date of 9/23/2022 to 9/28/2022. MS’s business model is to receive financial compensation to promote public companies. This compensation is a major conflict of interest in our ability to be unbiased regarding our alerts. 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 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, MS 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. , 26 Downing Street, Newark, NJ 07105, United States You may [unsubscribe]( or [change your contact details]( at any time. Powered by:[GetResponse](