Hyloris FIRST LOOK: Positive study results for Dofetilide IV, plans FDA submission

Hyloris announced positive results from a pivotal clinical study evaluating its proprietary Dofetilide IV formulation (potassium channel blocker), an antiarrhythmic to treat atrial fibrillation. Based on company guidance of FDA submission in the coming months, the product could be approved in the US by 2026 taking into account the 10 month FDA review timeline, and we look forward to learn more about the company's US commercialisation plans for its cardiology products. Note that Hyloris has previously stated that additional funding would be required to cover the commercialisation of its nearer-term cardiology products in the US with an internal sales team, though the company may consider partnering as an alternative. For now, we reiterate our € 5 TP and Hold rating.