Rapport's RAP-219 Clears Phase 2 Bipolar Mania Endpoint, Opening a Second Phase 3 Path

summarizeSummary

RAP-219 met the primary and secondary endpoints in a Phase 2 bipolar mania trial with a clean tolerability profile, adding a second late-stage indication to Rapport's lead asset. An FDA End-of-Phase 2 meeting is planned for Q1 2027, with two Phase 3 trials starting in 2H 2027, funded by $436.1M in cash through 2H 2029.

check_boxKey Events · Product Development and Regulatory · RAPP

• Phase 2 Bipolar Mania Trial Meets Endpoints

  In 253 randomized adults with bipolar I acute mania, RAP-219 produced a 3.1-point placebo-adjusted YMRS improvement at Week 3 (15.4 vs 12.3 point mean reduction; p=0.045) and a 0.4-point CGI-BP mania severity improvement (p=0.024).

• Clean Tolerability Versus Existing Therapies

  TEAE incidence was 51.6% on RAP-219 vs 52.8% on placebo, all events were mild or moderate, and there were no SAEs or severe TEAEs. No orthostatic hypotension, akathisia or extrapyramidal symptoms were reported, and somnolence was lower than placebo (0.8% vs 3.1%).

• Phase 3 Path and FDA Meeting Set

  Rapport plans an End-of-Phase 2 FDA meeting in Q1 2027 and initiation of two Phase 3 bipolar mania trials in 2H 2027, with a higher 1.25 mg dose and ex-US sites under consideration.

• Cash Runway Into Second Half 2029

  $436.1M in cash, equivalents and short-term investments as of June 30, 2026 is expected to fund operations into 2H 2029, beyond expected topline data from the Phase 3 focal onset seizure program.

auto_awesomeAnalysis · RAPP · Life Sciences

The readout matters because it turns RAP-219 from a single-indication epilepsy story into a pipeline-in-a-product with a second multibillion-dollar market. In acute bipolar mania, the drug delivered a 3.1-point placebo-adjusted YMRS improvement at Week 3 (p=0.045) and a 0.4-point CGI-BP severity improvement (p=0.024), with a tolerability profile free of the sedation, akathisia and extrapyramidal symptoms that drive discontinuation of current treatments. Rapport already holds $436.1M in cash to fund operations into 2H 2029, past expected Phase 3 focal onset seizure data. Still, the effect size is modest and the p-value only just under 0.05, so the Phase 3 program — two trials starting 2H 2027 after a Q1 2027 FDA meeting — will have to confirm the signal. One detail worth watching in the full dataset: the 24.6% treatment discontinuation rate in the RAP-219 arm versus 11.8% on placebo, mostly consent withdrawals.