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Tiziana Life Sciences seeks FDA Orphan Drug Designation for intranasal foralumab to treat Multiple System Atrophy
TLSATiziana Life Sciences Ltd
On September 30, 2026, Tiziana Life Sciences Ltd submitted a request to the U.S. Food and Drug Administration for Orphan Drug Designation for intranasal foralumab to treat Multiple System Atrophy (MSA). MSA is a rare neurodegenerative disorder with no currently approved disease-modifying therapies. If granted, the designation would provide seven years of market exclusivity upon approval, tax credits for clinical testing, and fee waivers. The company is concurrently evaluating intranasal foralumab in a Phase 2a open-label clinical trial at Brigham and Women’s Hospital to assess effects on microglial activation and safety. Tiziana Life Sciences Ltd operates as a clinical-stage biopharmaceutical company developing immunomodulation therapies using alternative drug delivery technologies.