Rapport Therapeutics plans to hold end-of-Phase 2 meeting with FDA in Q4

Rapport plans to hold an end-of-Phase 2 meeting with the U.S. Food and Drug Administration in the fourth quarter of 2025 and plans to initiate pivotal trials in the third quarter of 2026. The Company also expects to present additional efficacy analyses and 8-week follow-up results in 2026.By the end of 2025, Rapport plans to initiate an open-label long term safety trial to allow patients enrolled in the RAP-219-FOS-201 trial to continue on RAP-219. Preliminary results of the trial are expected in the second half of 2026. Additionally, Rapport continues development of a long-acting injectable formulation of RAP-219. Up to half of patients are nonadherent to prescribed ASMs, which can present a significant issue in optimizing treatment benefit and lead to potential breakthrough seizures. The Company believes a LAI formulation has the potential to improve patient adherence and expand the potential clinical utility across all of RAP-219’s indications. Outside of epilepsy, Rapport is evaluating RAP-219 in a Phase 2 trial in bipolar mania. The trial is currently enrolling patients and is on track, with topline results expected in the first half of 2027. An update on the plan and timeline for initiation of a Phase 2 trial in diabetic peripheral neuropathic pain is expected later in 2025.