> Kiadis Pharma warned investors it expects the European Medicines Agency to reject its request for conditional approval of ATIR101 in hematopoietic stem cell transplant patients. The setback would delay approval until at least 2021, when an interim analysis of a phase 3 trial is due to take place. Release
> A phase 2 trial of Bavarian Nordic’s CV301 in combination with Roche’s checkpoint inhibitor failed to clear the efficacy threshold for advancement. Bavarian Nordic responded by shifting the focus of its cancer strategy. Statement
> Idorsia delayed two clinical readouts. Results from a phase 3 trial of daridorexant in insomnia slipped from the first half of 2020 to the middle of the year. Slow enrollment in a phase 3 trial of lucerastat in Fabry disease caused that readout to slip, too. Release
> Abivax presented 12-month safety and efficacy data on ABX464 in ulcerative colitis. Statement
> Ipsen delayed its planned FDA filing for approval of palovarotene until the first quarter of 2020. The delay stems from “the processing of additional supportive data.” Release
> Vivoryon Therapeutics raised €43 million ($48 million). The money will support a phase 2 Alzheimer’s disease trial. Statement