May 11 Quick Takes: Genfit’s elafibranor misses in NASH Phase III; plus AstraZeneca, Merck, Protalix and TolerogenixX
Genfit’s PPAR agonist fails to resolve NASH
Genfit S.A. (Euronext:GNFT; NASDAQ:GNFT) fell $10.88 (49%) to $11.22 in after-hours trading Monday after reporting that dual PPARα/δ agonist elafibranor missed the primary endpoint of the Phase III RESOLVE-IT trial to treat non-alcoholic steatohepatitis (NASH). Buysiders had been watching the trial with caution, as fellow PPARδ inhibitor seladelpar from CymaBay Therapeutics Inc. (NASDAQ:CBAY) missed its primary endpoint in a Phase IIb NASH study in June (see “Why Buysiders say 2020 Could be the Year of the CNS”).
Expanded label for Lynparza
AstraZeneca plc (LSE:AZN; NYSE:AZN) and Merck & Co. Inc. (NYSE:MRK) said FDA approved an sNDA for their PARP inhibitor Lynparza olaparib plus Avastin bevacizumab as first-line maintenance treatment of homologous recombination deficiency (HRD)-positive platinum-sensitive advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) markets Avastin, an anti-VEGF mAb. ...