Tiziana Files for FDA Orphan Drug Designation for Intranasal Foralumab in MSA
TLSA sits 33% above its 52-week low of $0.762.
Summary
Tiziana has submitted a request to the FDA for Orphan Drug Designation for intranasal foralumab in Multiple System Atrophy (MSA), a rare neurodegenerative disease with no approved disease-modifying therapies. If granted, the designation would provide seven years of market exclusivity, tax credits, and fee waivers. The company is already running a Phase 2a trial in MSA, with PET imaging data from the third patient reported in July showing up to a 34% reduction in neuroinflammation. This filing is a logical next step and could strengthen the commercial outlook for the lead asset. FDA review of the request typically takes up to 90 days.
Updates
· SEC 6-K — The 6-K attaches the press release announcing the orphan drug designation request for intranasal foralumab in MSA.
At the time of this announcement, TLSA was trading at $1.01 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $122.4M. The 52-week trading range was $0.76 to $2.33. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.