Tiziana Life Sciences Ltd. (NASDAQ: TLSA) filed its seventh annual Development Safety Update Report (DSUR) with the U.S. Food and Drug Administration on December 29 2025. The report covers the period from September 21 2024 to September 2 2025 and documents 37.4 patient‑years of cumulative exposure to intranasal foralumab across multiple neuroinflammatory studies.
The safety data are compelling: no study‑drug–related serious adverse events were reported during the period. The exposure came from expanded access programs and clinical trials in non‑active secondary progressive multiple sclerosis (naSPMS), multiple system atrophy (MSA), and Alzheimer’s disease (AD). The absence of serious events over 37.4 patient‑years reinforces the safety profile of the fully human anti‑CD3 monoclonal antibody and supports the company’s ongoing development strategy.
The DSUR’s clean safety record is particularly noteworthy in the context of the FDA’s recent denial of Sanofi’s tolebrutinib for toxicity concerns in naSPMS. By demonstrating a strong safety profile, Tiziana positions its intranasal approach as a differentiated option in a therapeutic area where safety is a critical differentiator. The report may influence future trial design, dose selection, and the expansion of foralumab into additional indications.
Tiziana’s clinical pipeline is active across several neurodegenerative and neuroinflammatory diseases. A Phase 2 trial in naSPMS is ongoing, with results expected in 2026. A Phase 2a MSA trial began dosing in August 2025. An early‑stage AD Phase 2 trial dosed its first patient in December 2025, while an expanded access program for moderate AD started in December 2024. A Phase 2 ALS trial is planned for the second half of 2025.
CEO Ivor Elrifi highlighted the milestone of 37.4 patient‑years of exposure and the absence of serious adverse events, emphasizing the safety of the intranasal delivery platform. He also noted the FDA’s denial of tolebrutinib as evidence of the unmet need for safer therapies in neuroinflammatory disorders.
The clean safety data can bolster investor confidence, affirm regulatory compliance, and strengthen Tiziana’s competitive positioning. It provides a solid foundation for the company’s upcoming clinical milestones and may accelerate regulatory discussions for future indications.
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