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Shares of Tiziana Life Sciences (TLSA) rose more than 9% on Thursday after the company announced it has completed patient enrollment in its randomized, double-blind, placebo-controlled Phase 2a clinical trial of intranasal foralumab.
The study is evaluating the treatment in patients with non-active secondary progressive multiple sclerosis (na-SPMS).
Topline data is expected in late Q3 2026. It will also be presented at the 10th joint meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and ECTRIMS in Toronto, Canada, in October 2026.
The trial, known as INFORM-MS, is the first Phase 2 placebo-controlled study of intranasal foralumab. It marks an important milestone in the clinical development of this anti-CD3 monoclonal antibody for neurodegenerative and neuroinflammatory diseases.
The multi-center study has enrolled 48 patients across multiple U.S. sites who are receiving either one of two intranasal foralumab dose levels or placebo over a 12-week treatment period. The trial will assess outcomes using PET imaging for microglial activation, MRI scans, clinical evaluations, and biomarker analysis.
After the completion of the blinded phase, all participants, including those initially assigned to placebo, will be eligible to receive intranasal foralumab in a six-month open-label extension (OLE) phase. The extension will assess the drug’s long-term safety and whether its benefits are sustained in patients with na-SPMS.
Gabriele Cerrone, executive chairman and founder of Tiziana Life Sciences, said, “Intranasal delivery offers a novel, non-invasive route that targets the brain’s immune mechanisms directly.”
On Stocktwits, retail sentiment surrounding TLSA stock turned ‘extremely bullish’ from ‘bullish’ a day ago, with ‘high’ message volume.
One bullish user expects TLSA stock to hit “a new 52-week high very shortly.”
TLSA stock has gained over 15% year-to-date and around 28% in the past 12 months.
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