Genfit SA
9.16
EUR
+0.14
(+1.55%)
Genfit SA
MUN:XUP
(Munich Stock Exchange)
Recent
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9.16
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- Genfit S.A. (GNFT.PA) is a late-stage biopharmaceutical company focused on the discovery, development and commercialization of therapeutics and diagnostics targeting rare and life-threatening liver diseases with high unmet medical needs, particularly acute-on-chronic liver failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE), as well as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemias (OA); its therapeutic pipeline comprises eight programs across various development stages, including four ACLF assets with complementary mechanisms of action -- G1090N (reformulated nitazoxanide), SRT-015 (licensed ASK1 inhibitor from Seal Rock Therapeutics), CLM-022 (licensed inflammasome inhibitor from Celloram) and VS-02-HE -- plus GNS561 in CCA, VS-01-HAC in UCD/OA, alongside a diagnostic franchise featuring NIS2+ in metabolic dysfunction-associated steatohepatitis (MASH) and TS-01 for ammonia levels; elafibranor (Iqirvo), originally discovered and advanced by Genfit through Phase 3 in primary biliary cholangitis (PBC), is licensed globally to Ipsen (excluding China, Hong Kong, Taiwan and Macau) for development, manufacturing and commercialization, with Genfit receiving milestone payments and royalties on net sales. Founded in 1999 and headquartered at Parc Eurasanté in Loos, France, Genfit operates through subsidiaries GENFIT Corp. (USA) and Versantis AG (Switzerland), with offices in Paris, Zurich and Cambridge, MA; it serves worldwide markets in the biopharmaceutical sector, emphasizing data science, regulatory affairs and market access expertise demonstrated by Iqirvo's accelerated approvals in 2024 by the FDA, EMA and UK MHRA for PBC, now marketed in multiple countries including the US and several European nations. Recent developments include the March 2025 closing of a royalty financing agreement with HealthCare Royalty (HCRx) providing up to €185 million in non-dilutive capital (€130 million upfront plus up to €55 million in milestone-based installments), in exchange for a portion of Iqirvo royalties up to a cap, significantly extending cash runway beyond 2028; near-total repurchase of 2025 OCEANEs convertible debt for €61.7 million; a May 2025 €26.5 million milestone from Ipsen following Iqirvo pricing/reimbursement approval in Italy (third major European market); early 2025 acquisition of full worldwide intellectual property rights for GNS561 from Genoscience Pharma, terminating the prior limited license; Ipsen's July 2025 report of accelerated Iqirvo sales growth to €59 million in H1 2025 across the US and Europe; positive Phase 2 ELMWOOD data for elafibranor in primary sclerosing cholangitis (PSC) presented at EASL 2025; and September 2025 discontinuation of VS-01 in ACLF (including UNVEIL-IT trial) due to safety signals, with refocus on UCD preclinical development, alongside planned acceleration of remaining ACLF programs and GNS561 Phase 1b data by year-end.
Company News
Genfit S.A. (GNFTF) Discusses Developments and Guidance in MASH Diagnostics Transcript
GENFIT: Positive Phase 1b Data with GNS561 in Combination Therapy in Heavily Pretreated Patients with Cholangiocarcinoma
GENFIT: June 15, 2026 Combined Shareholders Meeting Results
GENFIT: NASHnext®, Powered by GENFIT's Non-invasive Diagnostic Technology NIS4®, Launched via Labcorp's OnDemand Offering for Identification of At-Risk MASH