New NASDAQ Alert [Inside]

AwesomeStocks Hello! New Alert: Tiziana Life Sciences Ltd (NASDAQ: TLSA) TLSA is our new high volatility breakout opportunity. Over the past month TLSA has experienced increased upside volatility after the company announced multiple breaking developments. In March, TLSA was trading under 0.70, and this week rallied as high as 1.39, experiencing gains of more than 98%. Now, TLSA has consolidated some of those gains, closing yesterday at 1.17 and could be presenting a new opportunity. Could it be positioned to experience continued massive upside like this? Its recent high is more than 18% from yesterday’s close suggesting the opportunity for increased gains if the upward momentum continues. TLSA is a “clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy”. TLSA’s “innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery”. The company’s “lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date”. As the company further explains: “Activated T cells play an important role in the inflammatory process.” “Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets”. In addition: “This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects.” Importantly, TLSA’s “technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications”. Sadly, “Multiple sclerosis (MS) is one of the most widespread disabling neurological conditions of young adults around the world”. Furthermore, “recent findings from the National MS Society estimate that nearly 1 million people in the United States are living with MS”. In addition, as the company explained in a recent press release: “Long COVID constitutes an unmet need in society. The estimated over 9 million people in the U.S. with Long COVID will cost the healthcare system a projected $2.6 trillion dollars” TLSA has announced multiple accomplishments recently that could be upward catalysts for the company’s continued growth. In March, the company announced potentially very important news: “Tiziana Life Sciences to Proceed with Phase 2 Clinical Trial in Patients with Non-Active Secondary Progressive Multiple Sclerosis (SPMS)” As the company further explains: - “FDA Provides Positive Feedback on Intranasal Foralumab Program in Patients with Non-Active SPMS” Here are some of the company’s highlights from this press release: - “First Phase 2 trial employing intranasal foralumab for treating inflammatory neurological disease” - “Tiziana received FDA Type C Meeting Minutes for proposed Phase 2 clinical trial in patients with non-active SPMS” - “Phase 2 protocol to be submitted to the FDA in April” - “Phase 2 clinical trial expected to start in Q3 2023” Here are the company’s comments from this press release: “Tiziana has reached an important regulatory milestone as it proceeds with the first ever intranasal foralumab clinical trial,” commented Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer. “The FDA’s response to our proposed Phase 2 program allows Tiziana’s to advance foralumab through the regulatory process as we strive to bring this novel treatment to patients with non-active SPMS.” Furthermore: “I am grateful for the FDA’s thoughtful review of our Phase 2 plans for intranasal foralumab,” stated Matthew W. Davis, M.D., RPh, Chief Medical Officer. “This upcoming quarter, we will update the Phase 2 protocol with the FDA’s suggestions and plan to start the Phase 2 clinical trial by holding our first investigator’s meeting in Q3 2023.” In addition, the company also announced: “Tiziana Life Sciences Announces Anti-CD3 mAb Research for the Treatment of Alzheimer’s Disease to be Presented by Dr. Howard Weiner at the International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurological Disorders Conference in Sweden” - “Data shows reduction of microglia activation and improvement in behavior in rodent model of Alzheimer’s disease (AD)” - “Modulation of neuroinflammation may be synergistic to existing treatments in AD” Earlier this month, the company announced: “Tiziana Announces Positive Data on Intranasal Anti-CD3 Monoclonal Antibody in Intracerebral Hemorrhage” - “Tiziana planning to advance foralumab, the only fully human anti-CD3 monoclonal antibody, into human testing for hemorrhagic stroke” - “Data shows behavioral outcomes improvement at one month in model of intracerebral hemorrhage (hemorrhagic stroke)” - “Modulation of neuroinflammation by inducing FoxP3+ Tregs appears to have beneficial effect in intracerebral hemorrhage” On April 4, the company also announced: “Tiziana Life Sciences Announces Invitation for Podium Presentation of Research on Intranasal Anti-CD3 mAb in Intracerebral Hemorrhage at the Annual American Academy of Neurology Conference” - “Dr. Saef Izzy’s data shows one-month behavioral outcomes improvement in model of intracerebral hemorrhage (hemorrhagic stroke)” - “Modulation of neuroinflammation by inducing FoxP3+ Tregs appears to have beneficial effect in intracerebral hemorrhage” - “Tiziana actively exploring the clinical development of foralumab into human testing for hemorrhagic stroke” Most recently, the company announced several big developments. Last week, the company announced: “Tiziana Life Sciences to Pursue Development of Intranasal Foralumab for the Treatment of Long COVID” Here are the highlights from this press release: - “Long COVID remains a high unmet need causing a myriad of complications for patients and costing the U.S. healthcare system an estimated $2.6 trillion” - “The role of activated microglia is well-established in the pathogenesis of Long COVID and Tiziana’s first-in-class intranasal foralumab dampens activated microglia” Here are the company’s comments from this press release: “We anticipate entering into a Phase 2a placebo-controlled clinical trial upon successful feedback from the FDA”, commented Matthew W. Davis, M.D., RPh, Chief Medical Officer of Tiziana. “I am excited to test intranasal foralumab in this medically important condition. The use of PET Scans will allow us to determine if intranasal foralumab will decrease activated microglia in patients with Long COVID after 3 months of administration. After refining our clinical protocols, we need to discuss this approach with the FDA and plan to file an IND in 4Q 2023.” But that’s not all… Two days ago, on Tuesday, the company announced big breaking news: “Tiziana Life Sciences Initiates Program to Develop Intranasal Foralumab in Type 1 Diabetes” Here are the highlights from this press release: - “CD3 antibody has emerged as an established and attractive target for Type 1 diabetes after the $2.9 billion acquisition of Provention Bio by Sanofi” - “Mechanism of Action of Tiziana’s first-in-class, only fully human CD3 antibody, intranasal foralumab, makes it an ideal candidate for Type 1 diabetes” - “Tiziana initiates program to study both the treatment and the delay of type 1 diabetes using its convenient self-administered intranasal foralumab” And… This morning, TLSA released another big announcement: “Tiziana Life Sciences to File Alzheimer’s IND for Intranasal Foralumab in Q2 2023” Here are the highlights from this press release: - “Application for $3M of non-dilutive funding for Phase 2a Alzheimer’s trial will be submitted in Q2 2023” - “Tiziana guided by FDA Type “B” meeting comments on its scheduled Q2 2023 intranasal foralumab Alzheimer’s IND filing” - “Alzheimer’s patients will be administered 3-months of intranasal foralumab to study effects on neuroinflammation caused microglia activation” TLSA has multiple potential catalysts in its favor to experience continued growth. Make sure to do your own due diligence. Sources: [Healthline]( [PR1]( [PR2]( [PR3]( [PR4]( [PR5]( [PR6]( [PR7]( [PR8]( [PR9]( [PR10]( [PR11]( [Website]( [Chart]( Happy Trading! AwesomeStocks Note: We encourage all traders and investors to develop personal trading rules that you can follow and that work for you. Always protect your downside and note that we alert extremely volatile short-term opportunities. Before investing in securities, you should always consult with your financial, tax and legal advisor and never invest money you cannot afford to lose. DISCLAIMER You should read and understand this disclaimer in its entirety before joining the website or email/blog list of AwesomeStocks.com (the “Publisher”). The information (collectively the “Advertisement”) disseminated by email, text or other method by the Publisher including this publication is a paid commercial advertisement and should not be relied upon for making an investment decision or any other purpose. 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