Tiziana Life Sciences Ltd (NASDAQ:TLSA) shares moved higher after the biotechnology firm revealed the US Food and Drug Administration (FDA) has granted Fast Track designation to its intranasal formulation of foralumab for the treatment of non-active secondary progressive multiple sclerosis.
The FDA’s Fast Track designation is intended to support the development of and review of drugs that address an unmet medical need.
Benefits of the designation include more frequent meetings with the FDA to go over the drug’s development plan, eligibility for Accelerated Approval and Priority Review if the required criteria are met, and a potential Rolling Review of the New Drug Application.
"We are thrilled to receive Fast Track designation from the FDA for intranasal foralumab for the treatment of Multiple Sclerosis (MS)," Tiziana Life Science CEO Gabriele Cerrone said in a statement.
"This designation underscores the potential of foralumab to address critical unmet needs in the treatment of neurodegenerative diseases. We are committed to advancing this promising therapy as quickly as possible to benefit patients."
Tiziana Life Sciences’ chief development officer Dr William Clementi added that the milestone was a testament to the company’s innovative approach with foralumab, a fully human anti-CD3 monoclonal antibody.
The company designed intranasal foralumab to modulate the immune system and reduce neuroinflammation, a key factor in the progression of neurodegenerative diseases such as MS, and early clinical data has shown the drug can deliver therapeutic benefits with a favorable safety profile.
"We believe that the intranasal delivery method offers a novel way to effectively target neuroinflammation, and we look forward to working closely with the FDA to bring this therapy to patients in need,” Dr Clementi said.
Shares of Tiziana Life Sciences added 13.7% at US$1.03 in early trade on Wednesday.