Ascletis Pharma (HKG:1672) obtained phase III trial clearance for obesity drug ASC30 from the U.S. Food and Drug Administration (FDA), according to a Monday Hong Kong bourse filing.
The company expects to announce topline data from the phase III program in the third quarter of 2028, with a U.S. FDA New Drug Application (NDA) filing anticipated by the end of that year.
A European Medicines Agency (EMA) Marketing Authorization Application (MAA) filing is also expected in early 2029.