Rapport Therapeutics Phase 2 bipolar mania trial meets endpoints

• Rapport Therapeutics reported that RAP-219 met both endpoints in a 253-patient bipolar mania trial, achieving a statistically significant 3.1-point placebo-adjusted improvement in manic symptoms at Week 3.
• All treatment-emergent adverse events during the three-week treatment period were mild or moderate, with no serious adverse events; treatment discontinuations due to adverse events were 3.2% with RAP-219 versus 0.8% with placebo.
• Rapport plans an FDA meeting in Q1 2027 and expects two Phase 3 bipolar mania trials to begin in the second half of 2027, supported by $436.1 million in cash and short-term investments reported at June 30, 2026.

Rapport Therapeutics (NASDAQ:RAPP) reported that its Phase 2 trial of RAP-219 in adults with acute bipolar mania met both primary and secondary endpoints.

The 253-patient study showed a 3.1-point placebo-adjusted improvement in manic symptoms at Week 3, with statistical significance of p=0.045.

Young Mania Rating Scale scores declined 15.4 points with RAP-219 versus 12.3 with placebo, while clinician-rated mania severity improved 0.4 points versus placebo.

Rapport plans to consult the FDA in Q1 2027 before launching two Phase 3 bipolar mania trials in the second half of 2027.

All treatment-period adverse events were mild or moderate, with no serious events, although adverse-event discontinuations were 3.2% versus 0.8% with placebo.

Rapport reported $436.1 million in cash and short-term investments at June 30, expecting sufficient funding into the second half of 2029.