Genfit (NASDAQ:GNFT) saw its stock decline 9% following the company’s announcement to discontinue its VS-01 therapy for Acute-on-Chronic Liver Failure (ACLF). The decision came after a safety incident in the UNVEIL-IT trial and a subsequent review by an independent Data Monitoring Committee (iDMC).
The company said the ACLF program, previously seen as its most prominent near-term growth opportunity, was paused due to a peritonitis case. Genfit will now redirect its VS-01 efforts toward Urea Cycle Disorder (UCD).
Safety concerns focused on infection risks linked to a four-day catheter placement in fragile ICU patients—a risk that had been previously noted by both key opinion leaders and the U.S. Food and Drug Administration.
With the ACLF program discontinued, Genfit’s near-term catalysts will include safety and early efficacy results for G1090N expected by the end of 2025, as well as phase Ib data for GNS561 in cholangiocarcinoma (CCA) by the same period.
Kepler analysts remarked: “Shares are likely to come under significant pressure today. However, we remind VS-01 in ACLF was not included in our valuation model. In our view, the market undervalues Genfit even on its existing business (Iqirvo royalties, cash and pipeline).”
The setback marks a major disappointment for the company, as promising phase II results could have driven a potential stock revaluation.
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