Tiziana Reports Clean FDA Safety Update for Intranasal Foralumab After 37.4 Patient-Years of Exposure
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Tiziana Life Sciences ( (TLSA) ) just unveiled an update.
On December 29, 2025, Tiziana Life Sciences reported that it has filed its seventh annual Development Safety Update Report with the U.S. Food and Drug Administration covering the period from September 21, 2024, to September 2, 2025, for its lead candidate, intranasal foralumab. The report, based on a cumulative 37.4 patient-years of exposure across expanded-access use in non-active secondary progressive multiple sclerosis, a randomized naSPMS trial and open-label extension, and a single-patient program in Alzheimer’s disease, found no study drug-related serious adverse events and no new safety risks requiring protocol changes, reinforcing the favorable tolerability of the nasal formulation versus historical intravenous anti-CD3 experience. Management framed the dataset against the FDA’s December 23, 2025 complete response letter denying Sanofi’s tolebrutinib for nrSPMS on toxicity grounds, underscoring a widening unmet need for safe therapies in progressive multiple sclerosis and positioning foralumab as a differentiated, potentially safer entrant ahead of a key Phase 2 readout in naSPMS expected in 2026.
The most recent analyst rating on (TLSA) stock is a Buy with a $8.00 price target. To see the full list of analyst forecasts on Tiziana Life Sciences stock, see the TLSA Stock Forecast page.
More about Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing breakthrough immunotherapies using alternative drug-delivery technologies, particularly intranasal administration. Its lead product candidate is intranasal foralumab, the only fully human anti-CD3 monoclonal antibody currently in clinical development, targeting neuroinflammatory and neurodegenerative diseases such as non-active secondary progressive multiple sclerosis, multiple system atrophy and Alzheimer’s disease, with a broader pipeline enabled by its patented delivery platforms.
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Technical Sentiment Signal: Hold
Current Market Cap: $175.9M
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