Tiziana Life Sciences Ltd. develops intranasal foralumab, a fully human anti-CD3 monoclonal antibody, as a clinical-stage biotechnology company focused on neuroinflammatory and neurodegenerative diseases. News for TLSA centers on clinical and preclinical data for intranasal anti-CD3 therapy, including non-active secondary progressive multiple sclerosis, Multiple System Atrophy, Alzheimer’s disease, ALS, Long COVID-associated neuroinflammation, and age-related cognitive decline.
Company updates also cover biomarker work involving CSF proteomics, TSPO-PET and microglial activation, peer-reviewed publications, scientific conference presentations, expanded-access observations, and financing actions such as registered direct offerings of ordinary shares and warrants.
Tiziana Life Sciences (TLSA) reported that its Phase 2a INFORM-MS trial of intranasal foralumab met both primary endpoints. The trial studied non-active secondary progressive multiple sclerosis. After 12 weeks, the 50 μg dose reduced microglial activation, an imaging measure of brain inflammation, versus placebo (p=0.0168); the 100 μg dose showed no statistically significant imaging difference. Both doses met the safety/tolerability endpoint, and all 48 participants completed treatment.
Fatigue scores improved from baseline by 6.17 points with 50 μg and 7.18 points with 100 μg, versus 3.12 points with placebo. Statistical significance was measured against each treatment group's own baseline, not placebo. The study was not powered for definitive clinical changes, and disability scores were unchanged. Tiziana plans full data analysis, a scientific presentation and FDA discussions about further development.
Tiziana Life Sciences (TLSA) management and business development representatives will attend MSToronto2026 in Toronto on October 21–23, 2026.
The joint ACTRIMS-ECTRIMS meeting takes place at the Metro Toronto Convention Centre. Representatives will be available to discuss the INFORM-MS trial of intranasal foralumab in non-active secondary progressive multiple sclerosis, ongoing studies in Alzheimer’s disease, multiple system atrophy and amyotrophic lateral sclerosis, and opportunities for scientific collaboration and business development.
Tiziana Life Sciences (TLSA) has begun dosing the last patient in its Phase 2 trial of intranasal foralumab for early/mild Alzheimer’s disease. Enrollment is complete, and all participants have started dosing; this milestone does not mark completion of treatment. The company anticipates announcing topline data in Q1 2027.
The randomized, placebo-controlled study evaluates foralumab alone and in combination with the FDA-approved anti-amyloid therapies lecanemab or donanemab. It assesses safety, tolerability and potential efficacy. Outcomes include changes in brain inflammation measured through TSPO-PET imaging, a scan used to assess activation of brain immune cells, alongside cognitive function and fluid biomarkers related to amyloid and tau pathology. The study tests an approach targeting inflammation both alone and alongside anti-amyloid treatment.
Tiziana Life Sciences (Nasdaq: TLSA) has requested FDA Orphan Drug Designation for intranasal foralumab to treat multiple system atrophy (MSA). The rare, progressive disorder affects autonomic functions and motor control and has no FDA-approved disease-modifying therapies. If granted, designation could provide seven years of market exclusivity upon approval, qualified clinical-testing tax credits, certain FDA application-fee waivers and protocol assistance eligibility.
Tiziana is evaluating the candidate in a six-month Phase 2a open-label trial at Brigham and Women’s Hospital in Boston. The study assesses microglial activation—activity of immune cells in the brain—using PET imaging, alongside clinical outcomes and safety. The FDA’s Office of Orphan Products Development aims to review designation requests within 90 days of receipt.
Tiziana Life Sciences (TLSA) dosed the first three participants in its Phase 2a BANYAN trial of intranasal foralumab for ALS. The company-sponsored study, co-funded by the ALS Association, plans to enroll 44 people with early amyotrophic lateral sclerosis (ALS). Participants are assigned to foralumab or placebo at a 3:1 ratio for 12 weeks, followed by a 12-week active-treatment extension.
The primary endpoint is safety and tolerability. Other measures include regulatory T cells, immune gene expression, neurofilament light chain levels and brain imaging of microglial activation. Eligible participants must have had symptoms for no more than 24 months, slow vital capacity of at least 65% and neurofilament light chain of at least 40 pg/mL. The trial is underway in Boston, with additional sites planned in Chicago, Minneapolis and Davie, Florida. No BANYAN safety or biomarker results were reported.
Tiziana Life Sciences (TLSA) reports that the last patient has completed the last visit in its Phase 2a INFORM-MS trial of intranasal foralumab in non-active Secondary Progressive Multiple Sclerosis (na-SPMS).
The randomized, double-blind, placebo-controlled study enrolled 48 patients across three cohorts at multiple U.S. sites and evaluates two intranasal foralumab doses versus placebo over 12 weeks. The primary endpoint is change in microglial activation by PET imaging, with secondary clinical measures including EDSS and MFIS. Tiziana plans to lock the database this week and announce 12-week topline data in October. After the blinded phase, all participants may receive intranasal foralumab in a six-month open-label extension to gather longer term safety and efficacy data. Separately, an Expanded Access Program in na-SPMS has treated 14 patients, all of whom showed disease stability or improvement within six months.
Tiziana Life Sciences (TLSA) signed a Memorandum of Understanding with King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, and the Foundation for Neurologic Diseases on September 16, 2026.
The parties intend to collaborate on a clinical trial combining Tiziana’s intranasal foralumab with existing anti-CD20 therapy in relapsing-remitting multiple sclerosis patients who respond poorly to anti-CD20 alone. Intranasal foralumab has reduced neuroinflammation in three clinical studies, and a Phase 2 trial in non-active secondary progressive MS remains blinded with results expected in October this year.
Tiziana Life Sciences (Nasdaq: TLSA) announced that Dr. Pinar Uysal will present a poster titled “Phase 2a Trial of Intranasal Foralumab – BANYAN, a Healey ALS MyMatch Trial” at ALS Nexus 2026 on August 24, 2026, in Orlando, Florida. The presentation will outline the BANYAN Phase 2a randomized, placebo-controlled, multicenter trial (3:1 foralumab:placebo) of intranasal foralumab in people living with ALS, including preclinical support, study design, and use of the ALS MyMatch Common Screening Protocol.
The BANYAN study, conducted across NEALS sites within the Healey ALS MyMatch infrastructure and supported by the ALS Association and foundations, is designed to assess safety, immune and neuroinflammation biomarkers, and early clinical signals. The trial is in its operational startup phase, with enrollment timing and site details to be announced. Tiziana highlights intranasal foralumab’s mechanism of expanding regulatory T cells to modulate neuroinflammation, and notes ongoing development in non-active secondary progressive multiple sclerosis, including an Expanded Access program and a separate Phase 2a dose-ranging trial.
Tiziana Life Sciences (Nasdaq: TLSA) reported that Chief Executive Officer Ivor Elrifi purchased 321,423 common shares on Nasdaq at $1.00 per share, increasing his total holding to 4,793,684 shares. The company focuses on immunomodulation therapies using its lead candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody.
According to Tiziana Life Sciences, 14 patients with non-active secondary progressive multiple sclerosis (na-SPMS) have been dosed in an open-label, intermediate-size Expanded Access Program, with improvement or disease stability observed within six months in all patients. Intranasal foralumab is also being evaluated in a Phase 2a randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in na-SPMS. The company states that foralumab is currently the only fully human anti-CD3 mAb in clinical development and has shown a favorable safety profile and clinical response in studies to date.
Tiziana Life Sciences (Nasdaq: TLSA) announced that Chief Executive Officer Ivor Elrifi purchased 667,000 common shares on Nasdaq at $1.00 per share, increasing his total holding to 4,472,261 shares. The company highlights its lead candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody being developed for immunomodulation.
According to Tiziana Life Sciences, 14 patients with non-active secondary progressive multiple sclerosis (na-SPMS) have been dosed with intranasal foralumab in an open-label expanded access program, with improvement or stability of disease observed within six months in all patients. Intranasal foralumab is also being evaluated in a Phase 2a randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in na-SPMS. The company states that foralumab is currently the only fully human anti-CD3 mAb in clinical development and that its intranasal delivery platform has shown a favorable safety profile and clinical responses to date.