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Tiziana Life Sciences Receives FDA Clearance for Alzheimer’s Treatment

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Tiziana Life Sciences Ltd.’s stock (TLSA) soared 41% in premarket trade on Tuesday following the announcement that the microcap biotech has received clearance from the Food and Drug Administration (FDA) for its investigational new drug application for intranasal foralumab, a potential treatment for Alzheimer’s disease.

Targeting the Underlying Pathology of Alzheimer’s Disease

Foralumab presents a promising breakthrough in the treatment of Alzheimer’s disease as it targets the disease’s underlying pathology by addressing the resulting neuroinflammation caused by the accumulation of toxic proteins in the brain, according to a statement released by Tiziana.

Moving Forward with Phase 2 Trial

With FDA clearance in hand, Tiziana will now be able to move forward with their Phase 2 trial of this fully human anti-CD3 monoclonal antibody. The antibody acts by binding to the T cell receptor and effectively dampening inflammation by modulating T cell function. Tiziana highlights that this effect has already been demonstrated in patients with COVID-19, multiple sclerosis, as well as in healthy individuals.

A Step Closer to a Potential Breakthrough Treatment

The Phase 2 trial for foralumab is expected to commence in the third quarter, marking an important milestone for Tiziana Life Sciences in their pursuit of a groundbreaking treatment for Alzheimer’s disease. As of now, the stock has seen a 0.6% increase year-to-date.


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