Tiziana Files Annual Safety Report for Intranasal Foralumab with FDA
Tiziana Life Sciences Ltd - Common Shares (TLSA)
Company Research
Source: GlobeNewswire
Tiziana reports excellent safety profile with intranasal foralumab after 37.4 patient-years cumulative exposureFDA 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 deny
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News
- Tiziana Life Sciences Announces New Biomarker Data Showing Nasal Foralumab Downregulates CSF Inflammation, Upregulates Neuroprotective Pathways, and Correlates with Reduced Microglial Activation on PET Scans in na-SPMS Patients with PIRAGlobeNewswire
- While insiders own 43% of Tiziana Life Sciences Ltd (NASDAQ:TLSA), individual investors are its largest shareholders with 53% ownership [Yahoo! Finance]Yahoo! Finance
- Tiziana Life Sciences Announces the Peer-Reviewed Publication of Clinical Study Results for Intranasal ForalumabGlobeNewswire
- Tiziana Life Sciences Announces Closing of Oversubscribed $8.8 Million Registered Direct Offering of Ordinary SharesGlobeNewswire
- Tiziana Life Sciences Announces Registered Direct Offering of up to approximately $17.6 MillionGlobeNewswire
TLSA
Sec Filings
- 2/25/26 - Form 6-K
- 2/20/26 - Form S-8
- 1/22/26 - Form AW
- TLSA's page on the SEC website