EMA grants PRIME status for 89bio’s pegozafermin
California, USA-based clinical-stage biopharmaceutical company 89bio (Nasdaq: ETNB) saw its shares gain more than 2% to $11.44 today, after it announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) status to pegozafermin in patients with metabolic-associated steatohepatitis (MASH).
The PRIME status was supported by positive data from the Phase IIb ENLIVEN trial of pegozafermin in patients with non-cirrhotic MASH with fibrosis (F2-F3) and MASH with compensated cirrhosis (F4).
MASH, formerly known as non-alcoholic steatohepatitis (NASH), is a more advanced form of metabolic dysfunction-associated steatotic liver disease (MASLD) which is a chronic, progressive disease in which fat accumulates in the liver, ultimately leading to scarring or fibrosis.
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