Rapport Therapeutics reports positive Phase 2 bipolar mania results for RAP-219
Rapport Therapeutics said its 253-patient Phase 2 trial of RAP-219 in adults with acute bipolar mania met its primary endpoint, with a 3.1-point placebo-adjusted improvement in YMRS total score at Week 3 (p=0.045). The company plans to meet the FDA in the first quarter of 2027 and expects to start two Phase 3 trials in the second half of 2027, while the filing also reports that 24.6% of patients on RAP-219 discontinued treatment versus 11.8% on placebo.
Key points
- Primary endpoint met: 3.1-point placebo-adjusted YMRS improvement at Week 3 (p=0.045); mean reduction of 15.4 points on RAP-219 versus 12.3 on placebo
- Treatment-emergent adverse events were similar (51.6% RAP-219 vs 52.8% placebo); no serious adverse events were reported
- Discontinuation of treatment: 24.6% on RAP-219 vs 11.8% on placebo; FDA meeting planned in Q1 2027
- Cash, cash equivalents and short-term investments were $436.1 million as of June 30, 2026, expected to fund operations into the second half of 2029
The filing
Written by AI on Nov 9, 2026, 11:46 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 20, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.