89bio gains FDA 'Breakthrough' status for pegozafermin

California, USA-based clinical-stage biopharmaceutical company 89bio (Nasdaq: ETNB) edged up 2% to $15.37 in morning trading, after it revealed that the US Food and Drug Administration (FDA) granted Breakthrough Therapy designation (BTD) to pegozafermin in patients with non-alcoholic steatohepatitis (NASH).

Pegozafermin has the potential to become one of the major players in the dyslipidemia space, according to data and analytics firm GlobalData, which, if approved, expects sales of the drug to reach $438 million by 2028.

“We are thrilled with this validation from the FDA awarding pegozafermin with Breakthrough Therapy Designation, which we expect will be advantageous for finalizing our Phase III development strategy in NASH following planned discussions with regulatory agencies in the fourth quarter of 2023,” said Rohan Palekar, chief executive of 89bio.