89bio receives EMA PRIME status for Pegozafermin

89bio announced that the European Medicines Agency has granted Priority Medicines status to pegozafermin in patients with MASH. The PRIME status was supported by positive data from the Phase 2b ENLIVEN trial of pegozafermin in patients with non-cirrhotic MASH with fibrosis (F2-F3) and MASH with compensated cirrhosis. “The EMA PRIME status further supports pegozafermin’s positioning as a leading FGF21 analog for the treatment of MASH, which has demonstrated robust anti-fibrotic and metabolic benefits as seen in our Phase 2b ENLIVEN trial,” said Rohan Palekar, Chief Executive Officer of 89bio. “This status recognizes the urgent need for effective treatment options for MASH patients with advanced fibrosis and underscores pegozafermin’s potential to address the targeted unmet medical need. We look forward to working closely with regulatory agencies as we continue to advance our Phase 3 clinical development program, ENLIGHTEN, aimed at potentially benefiting advanced MASH patients and MASH patients with compensated cirrhosis.”