Genfit's elafibranor wins orphan status for primary biliary cholangitis; Cidara stock soars on positive anti-fungal mid-stage data
→ NASH hopeful Genfit has been awarded orphan drug status by US and EU regulators for its experimental drug, elafibranor, to treat patients with primary biliary cholangitis (PBC), a chronic disease in which bile ducts in the liver are gradually destroyed. The PPAR dual agonist, which is in a pivotal trial involving NASH patients, is currently in mid-stage development for PBC. The French drug developer $GNFT recently made its Nasdaq debut, and last month inked up to $228 million deal with transpacific biotech Terns Pharmaceuticals to develop the liver drug in Greater China.
→ Shares of Cidara Therapeutics $CDTX rose on Monday as investigators reported encouraging data from their small Phase II study of the anti-fungal drug rezafungin. While the cohorts offered limited read through, the biotech spotlighted evidence that their antifungal had “numerically improved outcomes compared to caspofungin (Merck’s Cancidas) across all efficacy measures at the 400 mg/200 mg dosing regimen, which is the dosing regimen chosen for Phase III. They’ll need to get a positive outcome from the Phase III to prevail at the FDA. The stock jumped 35% to $2.16 in early Monday trading.
→ Denmark-based biotech Zealand Pharma $ZEAL is losing the services of its chief scientific officer Andrew Parker. The company, which focuses on gastrointestinal and metabolic diseases and counts Boehringer Ingelheim and Alexion Pharmaceuticals $ALXN as partners, said the search for a replacement is underway.