Rapport Therapeutics’ RAP-219 meets primary endpoint in Phase 2 bipolar mania trial
RAPP•Rapport Therapeutics said RAP-219 met primary and secondary endpoints in a Phase 2 trial for acute bipolar mania, significantly improving manic symptoms versus placebo. The company plans an FDA meeting in the first quarter of 2027 and expects two Phase 3 trials to begin in the second half.
1. Phase 2 results
Rapport Therapeutics announced that RAP-219 met the primary and secondary endpoints in its Phase 2 trial for acute bipolar mania, significantly improving manic symptoms versus placebo. All treatment-emergent adverse events were mild or moderate, with no serious adverse events. The company plans an FDA meeting in the first quarter of 2027 and expects two Phase 3 trials in the second half; additional Phase 2 results, including post-treatment safety data, are planned for a future medical meeting.
