EDSA - FDA grants fast track nod to Edesa's COVID antibody for respiratory distress

• Edesa Biotech ( NASDAQ: EDSA ) on Tuesday said it had been granted a fast track designation from the U.S. FDA for its monoclonal antibody candidate EB05 for the treatment of hospitalized COVID-19 patients with acute respiratory distress syndrome (ARDS).
• Shares of the micro-cap clinical-stage biopharma rose 6% to $0.96 in morning trade.
• The FDA's Fast Track approval is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
• The fast track nod follows favorable phase 2 results from an international mid-to-late stage study of EB05 in hospitalized COVID patients with ARDS.
• "The Fast Track designation will facilitate our interactions with the FDA and will also allow for faster review and approval upon successful completion of a Phase 3 development program," EDSA CEO Par Nijhawan said in a statement .

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