US FDA Requests Additional Clinical Evidence for Ascelia Pharma's Orviglance Application

01:38 AM EDT, 10/12/2026 (MT Newswires) -- Ascelia Pharma's (ACE.ST) new drug application for Orviglance requires additional clinical evidence from a new clinical study, according to minutes from its type A meeting with the US Food and Drug Administration published Sunday. At the same time, the regulator noted the potential to generate clinical evidence through a prospective analysis of images from the phase 3 sparkle study using a different primary endpoint. The Swedish biotechnology company, which does not intend to conduct another clinical study of the drug, will mull over the most efficient course for it in the US.