SVB Leerink launched coverage of French-based Genfit (NASDAQ:GNFT) with an “outperform” rating and $58 price target. The stock closed at $25.47 on April 23.
Genfit is a leader in nuclear receptor-based biology and clinical hepatology, with a focus on metabolic and liver related diseases, such as nonalcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC).
“Our core thesis in obesity-induced metabolic liver diseases, including nonalcoholic fatty liver disease (NAFLD) and NASH, is the utility of combining therapies that provide metabolic, and anti-inflammatory/fibrotic benefits on a background of practical weight loss therapies,” analyst Dr. Pasha Sarraf writes.
He said Genfits’s elafibranor may become “one of the first products entering the market that fits this thesis with reproducibly meaningful lipid and triglyceride lowering benefits, insulin sensitization and reduction of glycated hemoglobin, and impact on inflammatory hepatic pathology.”
Genfit expects to report a 72-week interim readout in the second half of 2019 of its Phase 3 RESOLVE-IT study of elafibranor in NASH, including F1-F3 patients across 317 centers.
The company, which recently received breakthrough designation from the FDA for elafibranor in PBC, also plans to initiate a Phase 3 study in second- line treatment of patients diagnosed with PBC and inadequate response to ursodeoxycholic acid, he added.
In addition, Genfit has developed a blood-based diagnostic algorithm, now partnered with LabCorp, to identify NASH patients who are candidates for treatment, and to replace core liver biopsy as a barrier to access.