Genfit (GNFTF,GNFT.PA) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to NTZ (nitazoxanide), its investigational small-molecule drug candidate. NTZ has been developed as a new formulation for the treatment of Acute-on-Chronic Liver Failure (ACLF), marking an important regulatory milestone for the program.
G1090N is GENFIT's lead investigational program within the ACLF segment of its pipeline. The FDA's ODD recognizes the potential of G1090N's active substance to address this severe, rare condition characterized by rapid deterioration, systemic inflammation, and high short-term mortality.
The designation follows recent Phase 1 data demonstrating a favorable safety and tolerability profile in healthy volunteers, as well as compelling anti-inflammatory activity across ex vivo models, providing a solid foundation for advancing the program toward initiation of Phase 2 clinical development, targeted for the second half of 2026. ODD also provides development incentives, including FDA regulatory guidance, certain user fee reductions, and eligibility for seven-year U.S. market exclusivity for the designated indication upon FDA approval.
GNFTF closed Monday at $7.87 on the OTC Market, down $2.13 or 21.30%.
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