Welcome to our dedicated page for Tiziana Life Sciences Com news (Ticker: TLSA), a resource for investors and traders seeking the latest updates and insights on Tiziana Life Sciences Com stock.
Tiziana Life Sciences Ltd. (NASDAQ: TLSA) is a clinical-stage biopharmaceutical company whose news flow centers on the development of intranasal foralumab, a fully human anti-CD3 monoclonal antibody, and related immunomodulation programs. Company announcements highlight progress in neuroinflammatory and neurodegenerative indications, including non-active secondary progressive multiple sclerosis, early Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS).
News about Tiziana often covers key clinical milestones. Recent releases describe dosing of patients in a Phase 2 randomized, placebo-controlled trial of intranasal foralumab in early Alzheimer’s disease, including evaluation as monotherapy and in combination with FDA-approved anti-amyloid therapies lecanemab and donanemab. Other updates report on the Expanded Access Program in non-active secondary progressive multiple sclerosis and the acceptance of the company’s ALS Phase 2 trial into the ALS MyMatch Program at the Sean M. Healey & AMG Center for ALS.
Investors following TLSA news can also expect regulatory and safety updates, such as the submission of Development Safety Update Reports to the U.S. Food and Drug Administration, which summarize cumulative exposure and safety findings for intranasal foralumab. Corporate and capital markets news includes insider share purchases by senior leadership, decisions regarding proposed public offerings, and participation in industry conferences like BIO-Europe, the Jefferies London Healthcare Conference, and neuroscience-focused forums.
This news page aggregates these company-issued press releases and related coverage, giving readers a centralized view of Tiziana’s clinical progress, regulatory interactions, strategic initiatives such as the planned spinout of IL-6 asset TZLS-501, and visibility events like ringing the Nasdaq Closing Bell. Users interested in TLSA can review this feed to monitor how Tiziana’s immunotherapy and drug delivery programs evolve over time.
Tiziana Life Sciences (NASDAQ: TLSA) announced that Executive Chairman and Founder Gabriele Cerrone has increased his stake in the company through the purchase of 15,000 common shares at $1.55 per share. Following this transaction, Cerrone's total holdings have reached 43,252,143 common shares, representing 37.02% of the company's issued share capital. Tiziana is developing immunomodulation therapies, with its lead candidate being intranasal foralumab, a fully human anti-CD3 monoclonal antibody.
Tiziana Life Sciences (NASDAQ: TLSA) has announced positive results from a clinical study of nasal foralumab in treating non-active secondary progressive multiple sclerosis (na-SPMS). The study involved 10 patients who were treated for a minimum of six months, with key findings including:
- No serious treatment-related adverse events reported
- Stabilization of Expanded Disability Status Scale (EDSS) scores in all patients
- Improvement in fatigue symptoms in 6 out of 10 patients
- Significant reductions in microglial activation at six months (p0.05)
- Increased regulatory T cells and TGFβ expression
The company has initiated a randomized, double-blind, placebo-controlled Phase 2 clinical trial with expected top-line data by the end of 2025. The treatment represents a novel approach for na-SPMS patients who currently have limited treatment options.
Tiziana Life Sciences (Nasdaq: TLSA) has announced the commencement of dosing at the University of Massachusetts, the fourth clinical site in its ongoing Phase 2 trial of intranasal foralumab for non-active secondary progressive multiple sclerosis (na-SPMS). UMass joins Brigham and Women's Hospital, Yale Multiple Sclerosis Center, and Johns Hopkins University in the study.
The blinded, placebo-controlled trial is expected to conclude by end-2025, followed by a six-month open-label extension phase where all participants can receive the treatment. Foralumab, the first fully human anti-CD3 monoclonal antibody administered intranasally, is designed to engage regulatory T cells and promote immune tolerance while minimizing systemic immune suppression.
The intranasal administration allows for at-home dosing, potentially improving compliance compared to intravenous treatments, particularly beneficial for patients dealing with fatigue.
Tiziana Life Sciences (Nasdaq: TLSA) has announced the commencement of dosing at Johns Hopkins University (JHU), the third clinical site in its Phase 2 trial of intranasal foralumab for non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The trial, also conducted at Brigham and Women's Hospital and MS Center at Yale Medical Center, is a randomized, double-blind, placebo-controlled study.
The trial aims to evaluate the safety, tolerability, and efficacy of intranasal foralumab, a fully human anti-CD3 monoclonal antibody, in na-SPMS patients who experience progressive neurological decline without relapses. The blinded portion is expected to complete by end of 2025, followed by a six-month open-label extension period where all participants can receive the treatment.
Tiziana Life Sciences (NASDAQ: TLSA) has commenced dosing new patients at Yale MS Center as part of its multicenter Phase 2 clinical trial evaluating intranasal foralumab for non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The trial is also enrolling at Johns Hopkins, U Mass Medical Center, and Brigham and Women's Hospital.
The double-blinded, placebo-controlled study aims to assess safety, tolerability, and foralumab's effect on microglial activation in na-SPMS patients. The trial combines brain PET imaging, immunology, and FDA-accepted clinical evidence measures.
Expected completion is by end of 2025, followed by a 6-month open-label extension (OLE) study to evaluate long-term safety, tolerability, and durable effectiveness. Foralumab, a fully human anti-CD3 monoclonal antibody, represents a novel approach to potentially mitigate SPMS progression.
Tiziana Life Sciences (Nasdaq: TLSA), a biotechnology company focused on developing breakthrough immunomodulation therapies, has announced its participation in the 37th Annual ROTH Conference from March 16-18, 2025, in Dana Point, California.
CEO Ivor Elrifi will lead a virtual fireside chat on Tuesday, March 18, 2025, at 12:00 pm PST (15:00 ET / 19:00 GMT). The company will also participate in one-on-one investor meetings during the conference.
The event will feature approximately 450 private and public companies from various growth sectors, offering opportunities for 1-on-1 meetings, analyst-selected fireside chats, and industry keynotes. Tiziana's lead development candidate is intranasal foralumab, a fully human, anti-CD3 monoclonal antibody.
Tiziana Life Sciences (Nasdaq: TLSA) has successfully regained compliance with Nasdaq's minimum bid price requirement for continued listing on the Nasdaq Capital Market exchange. The company, which develops immunomodulation therapies with its lead candidate intranasal foralumab (a fully human, anti-CD3 monoclonal antibody), had received a non-compliance notice on January 29, 2025, for failing to maintain a closing bid price of $1.00 or more for 30 consecutive business days under Rule 5550(a)(2).
The company met the requirement to maintain a minimum closing bid price of $1.00 or more for at least ten consecutive trading days on March 12, 2025, resolving the compliance issue. As a result, Tiziana's securities will continue to be listed and traded on The Nasdaq Stock Market.
Tiziana Life Sciences (Nasdaq: TLSA) has submitted an Investigational New Drug (IND) application to the FDA for a phase 2 clinical trial of intranasal foralumab in Amyotrophic Lateral Sclerosis (ALS) patients. The trial, supported by an ALS Association grant through the Hoffman ALS Clinical Trial Awards Program, will evaluate two doses of the company's intranasal foralumab in 20 patients.
Foralumab, a fully human anti-CD3 monoclonal antibody, represents Tiziana's lead development candidate. The company's intranasal foralumab programs now target three neurodegenerative diseases: ALS, Multiple Sclerosis, and Alzheimer's disease.
ALS, also known as Lou Gehrig's disease, is a fatal neurodegenerative condition affecting nerve cells in the brain and spinal cord, leading to muscle weakness and paralysis. Most patients survive less than five years after diagnosis, highlighting the urgent need for new treatment options.
Tiziana Life Sciences (NASDAQ: TLSA) has published a groundbreaking study in Nature Neuroscience demonstrating significant positive results for their nasal anti-CD3 therapy in treating traumatic brain injury (TBI). The study shows that nasal administration of Tiziana's anti-CD3 monoclonal antibody, foralumab, effectively reduced neuroinflammation and improved recovery.
The research, led by Dr. Saef Izzy at Brigham and Women's Hospital, revealed that the therapy induces IL-10 producing regulatory T cells that migrate to the brain and modulate microglia activity. Key improvements observed in the preclinical model included:
- Reduced anxiety
- Less cognitive decline
- Improved motor skills
The study validates the mechanism of action of foralumab and its potential application in treating various neuroinflammatory conditions, including Multiple Sclerosis, Alzheimer's disease, and ALS. This breakthrough is particularly significant as there are currently no effective treatments available for TBI, which remains a major unmet medical need.