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Tiziana Life Sciences reported that the U.S. Food and Drug Administration has approved an Investigational New Drug (IND) application for a Phase 2a clinical trial of intranasal foralumab in patients with Multiple System Atrophy (MSA).
The company states MSA is an unmet medical need with no FDA-approved therapies and is described as an orphan-designated disease. The announcement is furnished as Exhibit 99.1 to this Form 6-K.