Clinical Trial Highlights slide image

Clinical Trial Highlights

Pipeline: near-term milestones IPSEN Innovation for patient care Palovarotene FDA PDUFA FOP 16 August Bylvay Regulatory decision (E.U.) ALGS H21 Onivyde FDA PDUFA 1L PDAC 13 February Cabometyx + atezolizumab Phase III data readout 2L mCRPC H2 Elafibranor Regulatory submission (U.S., E.U.) 2L PBC H2 1. Subject to the outcome of an appeal procedure. PDUFA: Prescription Drug User Fee Act; FOP: fibrodysplasia ossificans progressiva; ALGS: Alagille syndrome; 1L: first line; PDAC: pancreatic ductal adenocarcinoma; 2L: second line; mCRPC: metastatic castration-resistant prostate cancer; PBC: primary biliary cholangitis. 6
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