: Tiziana Life Sciences’ stock soars 54% premarket after FDA clear path for trial of intranasal treatment for Alzheimer’s disease

Tiziana Life Sciences Ltd.’s stock TLSA soared 54% in premarket trade Tuesday, after the microcap biotech said it has received clearance from Food and Drug Administration for its investigational new drug application for intranasal foralumab, a treatment for Alzheimer’s disease. “Foralumab could be a potentially groundbreaking treatment for Alzheimer’s disease, given it targets the disease’s underlying pathology by addressing the resulting neuroinflammation caused by the accumulation of toxic proteins in the brain,” the company said in a statement. The move will allow the company to move the anti-CD3 monoclonal antibody into a Phase 2 trial. Foralumab is the only fully human anti-CD3 monoclonal antibody, and acts by binding to the T cell receptor and dampening inflammation by modulating T cell function. “This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects,” said Tiziana. The Phase 2 trial is expected to start in the third quarter. The stock is up 0.6% in the year to date

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