Stifel says FDA alignment on accelerated path ‘looks like best case’ for uniQure

After uniQure (QURE) announced they have achieved alignment with the FDA on key elements of an accelerated approval pathway for AMT-130, Stifel said this “looks like a best-case scenario,” noting that the company can use an external control and leverage data from the ongoing Phase 1/2 study and can use cUHDRS as the endpoint. This is “a big win for the stock in the backdrop of low expectations that an accelerated path could actually materialize,” says the analyst, who looks forward to more color as uniQure engages the FDA throughout the first half of 2025. Stifel has a Buy rating on uniQure shares, which are up $7.01, or 96%, to $14.30 in pre-market trading.