Core Insights - GENFIT reported its third quarter 2025 financial results, highlighting a focus on developing treatments for rare and life-threatening liver diseases, particularly Acute on-Chronic Liver Failure (ACLF) [1][22] Financial Performance - As of September 30, 2025, the company's cash and cash equivalents increased to €119.0 million from €107.5 million as of June 30, 2025, and €81.8 million as of December 31, 2024 [2][10] - Revenue for the first nine months of 2025 was €39.2 million, a decrease from €59.7 million in the same period of 2024 [5] - The revenue was primarily driven by a Licensing and Collaboration Agreement with Ipsen, which included €12.6 million in royalty revenue and €26.5 million in milestone revenue from pricing and reimbursement approvals for Iqirvo (elafibranor) in three major European markets [6][10] Pipeline Development - The company is advancing its ACLF pipeline, with several programs in various stages of development: - G1090N is undergoing a Phase 1 First-in-Human study, with safety data expected by the end of 2025 [7] - SRT-015 aims to improve formulation for increased exposure, with a potential first-in-human trial in the second half of 2026 [7] - CLM-022 is in experiments to confirm therapeutic efficacy, with a first-in-human trial potentially starting in the first half of 2027 [8] - VS-02-HE is being developed as an oral formulation targeting gut ammonia production, with a first-in-human trial expected in the second half of 2027 [9] - GNS561 is in a Phase 1b clinical trial for cholangiocarcinoma, with data readout expected by the end of 2025 [11] Market Position - Iqirvo (elafibranor) continues to show solid growth in both U.S. and European markets for Primary Biliary Cholangitis (PBC), as reported by Ipsen [13]

Core Points - GENFIT has announced the effective voluntary delisting of its American Depositary Shares (ADSs) from the Nasdaq Global Select Market, with each ADS representing one ordinary share of the company [1] - The company has filed a Form 15F with the SEC to suspend its reporting obligations under the Securities Exchange Act of 1934, with the deregistration expected to be effective 90 days after the filing [1] Company Information - GENFIT is a biopharmaceutical company focused on improving the lives of patients with rare and life-threatening liver diseases, with a history of over two decades in liver disease research and development [7] - The company is headquartered in Lille, France, and has additional offices in Paris, Zurich, and Cambridge, MA [11] - GENFIT's R&D portfolio includes therapeutic assets targeting conditions such as Acute on-chronic Liver Failure (ACLF), cholangiocarcinoma (CCA), and urea cycle disorders (UCD) [8] ADS Holder Information - The Bank of New York Mellon serves as the depositary for GENFIT's ADS facility, and the company intends to terminate the Deposit Agreement on or about February 6, 2026 [2] - ADS holders have until February 9, 2026, to surrender their ADSs for the underlying ordinary shares, with applicable fees for cancellation and cable services [3] - After February 9, 2026, the depositary may sell the underlying ordinary shares, and ADS holders must surrender their securities to obtain payment of the sale proceeds, net of expenses [4][6]

Core Insights - The treatment landscape for primary biliary cholangitis (PBC) has significantly evolved with the recent approvals of Gilead's Livdelzi (seladelpar) and Ipsen's Iqirvo (elafibranor), marking progress in disease management [1] - Pruritus remains a significant unmet need for PBC patients, with many suffering from moderate to severe symptoms that impact their quality of life [2] Treatment Developments - GSK's linerixibat, an ileal bile acid transporter (IBAT) inhibitor, has had its New Drug Application accepted by the FDA for treating cholestatic pruritus in PBC patients, with a target action date of March 24, 2026 [3] - Gastroenterologists express a high likelihood of incorporating linerixibat into treatment if approved, noting its potential for significant symptom reduction despite concerns over side effects like abdominal pain and diarrhea [3] Market Analysis - Spherix Global Insights' Market Dynamix™ service provides analysis on markets expected to undergo significant changes in the next three to five years, focusing on market size, treatment approaches, unmet needs, and expert opinions on pipeline agents [4] - The service aims to track emerging developments in the PBC treatment landscape and pipeline, highlighting the ongoing demand for effective therapies targeting pruritus [3][4]