The FDA granted Orphan Drug Designation to NTZ (nitazoxanide), Genfit's investigational small-molecule new formulation for the treatment of Acute-on-Chronic (article truncated). Orphan status confers regulatory incentives (eg. US orphan market exclusivity, tax credits and fee waivers) and should modestly enhance the program's commercial and financing optionality, likely producing a low single-digit percent move in Genfit's shares on the news.
The FDA granted Orphan Drug Designation to NTZ (nitazoxanide), Genfit's investigational small-molecule new formulation for the treatment of Acute-on-Chronic (article truncated). Orphan status confers regulatory incentives (eg. US orphan market exclusivity, tax credits and fee waivers) and should modestly enhance the program's commercial and financing optionality, likely producing a low single-digit percent move in Genfit's shares on the news.
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