New NASDAQ Alert [Inside]

AwesomeStocks Don’t want emails from us anymore? Click [here]( to unsubscribe. Hello! New Alert: Tiziana Life Sciences Ltd (NASDAQ: TLSA) TLSA is our new NASDAQ high volatility breakout alert. Over the past few weeks TLSA has been consolidating, but on Friday, it had a big up day. Could this be the start of a sustainable breakout higher? 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: “The non-active SPMS intranasal foralumab Phase 2 trial is expected to start screening in November of 2023.” “Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.” 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”. TLSA has announced multiple accomplishments recently that could be upward catalysts for the company’s continued growth. In August, the company announced: “Tiziana Life Sciences Announces FDA IND Clearance of Intranasal Foralumab for the Treatment of Alzheimer’s Disease” - “Foralumab to advance into Phase 2 human clinical trials using the world’s only fully human intranasal anti-CD3 monoclonal antibody” - “Trial to be overseen by Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System” Here are the company’s comments from this press release: “Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences, stated, "The IND clearance is a significant milestone for Tiziana that highlights the strength and the therapeutic potential of foralumab. We are deeply committed to advancing the field of neurodegenerative diseases and bringing much-needed relief to patients suffering from Alzheimer's with a novel therapeutic approach. We are thrilled to have reached this critical juncture and are eager to move forward with the necessary trials to evaluate the effectiveness of foralumab in Alzheimer’s disease in combination with an FDA approved therapy or as a single agent."” In addition: “Professor Howard L. Weiner, the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, added "The IND clearance is a significant step forward in the fight against Alzheimer's disease. Foralumab shows great promise in targeting the pathological hallmarks of the disease, and I am optimistic about its potential to offer a breakthrough treatment option for patients suffering from this devastating condition. I look forward to witnessing the progress of this important therapy."” In September, the company announced: “Study Validating MoA of Intranasal Foralumab in Alzheimer’s Disease Published in the Prestigious Journal PNAS, Following FDA IND Clearance” Here are the highlights from this press release: - “The authors conclude that “nasal anti-CD3 has the potential to be a non-toxic novel immunotherapeutic approach for the treatment of Alzheimer’s disease (AD)”” - “FDA has cleared the IND for intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for human study in mild to moderate Alzheimer’s Disease” - “The publication shows anti-CD3 monoclonal antibody (mAb) administered intranasally, ameliorates disease in a 3xTg model of Alzheimer’s disease by targeting microglial activation in the brain, while expanding regulatory T cells in the periphery” - “Remarkably, this reduced microglial activation and improved cognition occurs independent of amyloid beta disposition.” In addition, the company also announced: “Tiziana Life Sciences Initiates Multi-Center Phase 2a Clinical Trial of Intranasal Foralumab for Non-Active Secondary Progressive Multiple Sclerosis” Here are some of the company’s comments from this press release: “Matthew W. Davis, M.D., RPh, Chief Operating Officer and Chief Medical Officer of Tiziana Life Sciences, stated, “As planned for this quarter, we are on track and have begun site initiation visits so patient enrollment begins in this critical clinical trial. Advancing our lead anti-CD3 therapeutic, foralumab, in na-SPMS into Phase 2a will enable Tiziana to define novel endpoints, such as PET imaging, a similar target endpoint in our Expanded Access program (EAP). We are encouraged as five out of six patients in our open-label EAP have improved by qualitative analysis in their PET scans (3 months of treatment) compared to baseline. Phase 2a na-SPMS study assesses the same outcome measure, but now, and for the first time for this novel therapeutic, in a double-blind, randomized placebo control, a multi-center trial is now underway.” Most recently, on Friday, the company announced big breaking news: “Tiziana Announces Positive Qualitative Six-Month PET Scan Results With Intranasal Foralumab Treating Multiple Sclerosis Patients Diagnosed With Non-Active Secondary Progressive MS (na-SPMS)” Here are the highlights from this press release: - “Five out of six patients in FDA authorized Expanded Access Program are showing a qualitative reduction in microglia activation (a key biomarker being observed)” - “Foralumab to advance into Phase 2 human clinical trials using the world’s only fully human intranasal anti-CD3 monoclonal antibody” - “Phase 2 trial screening for na-SPMS to begin in November 2023” But that’s not all... Just this morning, the company announced breaking news: “Tiziana Life Sciences Announces Positive Six-Month Clinical Results in Multiple Sclerosis Patients Treated with Intranasal Foralumab” Here are some of the key highlights from this press release: - “Numeric improvements were seen across key multiple sclerosis measures, including the Modified Fatigue Impact Scale, Expanded Disability Status Scale, Timed 25-Foot Walk test, Pyramidal Scores and NeuroQoL™ Fatigue scores.” - “Data was presented at ECTRIMS (39th Congress of the European Committee for Treatment and Research of Multiple Sclerosis) on October 11, 2023” 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]( [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. 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