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 (TLSA) is a clinical-stage biotechnology innovator developing intranasal immunotherapies for neurodegenerative and inflammatory diseases. This page provides centralized access to official corporate announcements, clinical trial updates, and strategic developments.
Investors and researchers will find timely updates on TLSA's novel drug delivery platform, including progress with intranasal foralumab and other candidates targeting multiple sclerosis, Alzheimer's, and autoimmune conditions. The repository includes press releases on FDA communications, partnership announcements, and peer-reviewed research findings.
Key content categories include clinical trial milestones, intellectual property updates, executive leadership changes, and financial performance reports. All materials are sourced directly from the company and verified financial news outlets to ensure accuracy.
Bookmark this page for streamlined tracking of TLSA's progress in advancing non-invasive immunotherapy solutions. Check regularly for updates on groundbreaking approaches to modulating immune responses through nasal administration.
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.
Tiziana Life Sciences (Nasdaq: TLSA) announced that a nasal anti-CD3 (foralumab) preclinical study for Long COVID is nearing completion in the second quarter of 2025. Foralumab, a fully human anti-CD3 monoclonal antibody, could offer a novel treatment for Long COVID by reducing microglial activation, which contributes to persistent brain inflammation associated with the condition.
Long COVID affects millions worldwide with symptoms including fatigue, cognitive impairment ("brain fog"), and psychiatric issues like depression. PET imaging studies confirm increased microglial activity in Long COVID patients, highlighting the need for targeted therapies.
Previously, Tiziana conducted a human clinical study where foralumab was nasally administered to COVID-19 patients for 10 consecutive days, showing good tolerability and significant reduction in lung inflammation. The company's nasal anti-CD3 platform has also demonstrated efficacy in reducing microglial activation in models of multiple sclerosis and Alzheimer's Disease.
Tiziana Life Sciences (NASDAQ: TLSA) has announced a product development services agreement with Renaissance Lakewood , a Contract Development and Manufacturing Organization (CDMO) specializing in nasal drug delivery. The collaboration focuses on optimizing the formulation and scaling up production of intranasal foralumab, Tiziana's lead development candidate.
The partnership aims to advance the development of intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for treating neurodegenerative and inflammatory diseases. Renaissance will leverage its expertise in pharmaceutical-nasal product development and manufacturing to ensure compliance with quality and regulatory requirements.
Recent studies have shown that intranasal foralumab can activate regulatory T cells that cross the blood-brain barrier, reducing neuroinflammation in conditions like Alzheimer's disease and multiple sclerosis. This collaboration represents a strategic step toward clinical development and potential commercialization of the treatment.
Tiziana Life Sciences (TLSA) has announced the dosing of four additional patients in its Intermediate Size Patient Population Expanded Access (ISPPEA) program for non-active secondary progressive multiple sclerosis (na-SPMS). The program now includes 14 patients total, with the first 10 patients showing either improvement or disease stability within 6 months of treatment initiation.
The expanded access program utilizes intranasal foralumab, the company's lead development candidate and a fully human, anti-CD3 monoclonal antibody. This program specifically targets patients who don't qualify for the ongoing Phase 2a clinical trial (NCT06292923), providing access to this investigational therapy for those who might not otherwise receive it.
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