Genfit

GENFIT reports that the drug candidate G1090N showed a favorable safety profile in a Phase‑1 study of 76 healthy volunteers and, in ex‑vivo tests, strong inhibition of pro‑inflammatory signaling pathways (up to 76% reduction in LPS‑induced cytokines). The data support progression to further clinical trials; GENFIT plans discussions with regulators, including the FDA, to prepare Phase‑2 proof‑of‑concept studies for ACLF and related indications. The stock trades near its 52‑week high after rising more than 55% over the past six months. » Więcej na de.investing.com

Genfit appoints Dr. Pejvack Motlagh effective immediately as chief medical officer; he brings more than 20 years of experience in pharma and biotech and will, as a member of the Executive Committee, lead the clinical development strategy as well as the clinical, biometrics and pharmacovigilance teams. The announcement comes against the backdrop of strong stock price momentum. In parallel, Genfit halted treatment with VS-01 for acute-on-chronic liver failure after a safety incident and will concentrate resources on the VS-01 program for urea cycle disorders. The company recently received accelerated approvals for Iqirvo (Elafibranor) in the US, Europe and the UK. » Więcej na de.investing.com

Genfit reports discontinuation of the VS-01 treatment for acute-on-chronic liver failure (ACLF) following a case of peritonitis during the UNVEIL-IT study and a review by an independent data monitoring committee. The shares fell about 9% as a result. The company now plans to redirect VS-01 to urea cycle disorders (UCD); near-term catalysts are safety and early efficacy data for G1090N and Phase Ib data for GNS561 in cholangiocarcinoma by the end of 2025. Analysts note that VS-01 was not previously included in their valuation models but still view the stock as overall undervalued. » Więcej na de.investing.com