89bio receives ema prime status for pegozafermin in the treatment of metabolic dysfunction-associated steatohepatitis (mash) with fibrosis and compensated cirrhosis
–prime status is supported by positive data from the phase 2b enliven trial of pegozafermin– –phase 3 enlighten-fibrosis trial in non-cirrhotic mash (fibrosis stage f2-f3) patients is enrolling and enlighten-cirrhosis in mash patients with compensated cirrhosis (f4) is planned to initiate in the second quarter of 2024– san francisco, march 27, 2024 (globe newswire) -- 89bio, inc. (nasdaq: etnb), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that the european medicines agency (ema) has granted priority medicines (prime) 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 (f4).
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