uniQure upgraded at Mizuho on potential improvement in regulatory outlook

As previously reported, Mizuho upgraded uniQure (QURE) to Outperform from Neutral with a price target of $35, up from $12, arguing that Friday’s “unexpected” announcement that Dr. Vinay Prasad will depart the FDA, just days after a highly public dispute with uniQure, “appears to signal an administration-level desire to restore greater regulatory flexibility in rare disease development.” The firm believes this leadership change is “constructive for uniQure,” potentially reopening a path to a BLA based on the existing Phase 1/2 data or a Phase 3 trial leveraging natural history controls, the analyst tells investors.