Tiziana Life Sciences Files FDA Orphan Drug Application for Foralumab in MSA

Tiziana Life Sciences (TLSA) said on September 30, 2026, it submitted a request to the FDA for Orphan Drug Designation for intranasal foralumab to treat Multiple System Atrophy, a rare neurodegenerative disorder. Foralumab is a fully human anti-CD3 monoclonal antibody in development as an intranasal immunomodulatory therapy for neuroinflammatory and neurodegenerative diseases. Tiziana is evaluating the candidate in a six-month Phase 2a open-label study in MSA patients, assessing microglial activation via PET imaging, clinical outcomes and safety. If granted, the designation would offer potential market exclusivity, tax credits for qualified clinical testing and waiver of certain FDA application fees. TLSA closed at $0.95 on September 29, down 2.73%. Premarket shares fell 1.43% to $0.94.