Tiziana Files Annual Safety Report for Intranasal Foralumab with FDA [Yahoo! Finance]
Sanofi - American Depositary Shares (SNY)
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Source: Yahoo! Finance
FDA denial of Sanofi's tolebrutinib for nrSPMS shows need for safe therapy BOSTON, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA ) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces the submission of its seventh annual Development Safety Update Report (DSUR) to the U.S. Food and Drug Administration (FDA). This DSUR (September 21, 2024, to September 2, 2025), reports no drug-related serious adverse events after a cumulative exposure of 37.4 patient-years, highlighting the safety and tolerability data profile of intranasal foralumab in treating neuroinflammatory diseases, including non-active secondary progressive multiple sclerosis (naSPMS), multiple system atrophy and Alzheimer's Disease (AD). “The FDA's December 23, 2025 complete response letter denying approval of Sanofi's tolebrutinib for nrSPMS, based on toxicity, highlights the need for a safe therapy f
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- 12/29/25 - Form 6-K
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