other material
confidence high
sentiment positive
materiality 0.80
Rapport's RAP-219 hits Phase 2 primary endpoint in bipolar mania (3.1-pt YMRS gain, p=0.045)
Rapport Therapeutics, Inc.
- Phase 2 met primary endpoint: 3.1-point placebo-adjusted YMRS improvement at Week 3 (p=0.045); 15.4-point mean reduction from baseline vs 12.3 on placebo.
- Secondary CGI-BP mania severity improved 0.4 points vs placebo (p=0.024); all 11 YMRS items improved, with 4 reaching nominal significance.
- 253 adults with bipolar I mania enrolled (126 on RAP-219 0.75 mg, 127 placebo); all TEAEs mild or moderate, no SAEs; 3.2% vs 0.8% discontinued for TEAE.
- Plans FDA End-of-Phase 2 meeting in Q1 2027 and two Phase 3 bipolar mania trials starting 2H 2027; FOS FOCUS 1/2 enrolling, PGTCS Phase 3 1H 2027.
- $436.1M in cash, equivalents and short-term investments as of June 30, 2026; runway into 2H 2029, beyond FOS Phase 3 topline data.
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