Key Takeaways
- Rapport Therapeutics shares rose 4% today after its drug RAP-219 beat placebo by 3.1 points on a mania rating scale in a Phase 2 bipolar mania trial.
- Bipolar mania gives RAP-219 a second shot on goal next to epilepsy, which makes Rapport worth more even after today’s jump.
- The catches are a modest edge over placebo, more agitation on the drug (16.7% vs. 9.4%) and about twice as many patients stopping treatment early.
- Rapport plans to meet with the FDA in the first quarter of 2027 and start two Phase 3 trials in the second half, with cash it expects to last into the second half of 2029.
Rapport Therapeutics (RAPP) shares are up 4% this morning after its lead drug, RAP-219, met its main goal in a Phase 2 bipolar mania trial. (Before the open, they were up far more.)
What exactly happened
The trial gave RAP-219 or placebo to 253 adults in a manic episode for three weeks:
- RAP-219 cut scores on the Young Mania Rating Scale, a 60-point rating done by a clinician, by 15.4 points. Placebo cut them by 12.3, so the drug’s edge was 3.1 points (p=0.045).
- It also met its secondary goal, a clinician’s overall rating of how severe the mania is (p=0.024).
- Every side effect was mild or moderate, and none were serious.
That last point is the pitch. CEO Abraham N. Ceesay says side effects push patients off their drugs and into relapse, and “RAP-219 has the potential to break that cycle with the first new mechanism of action for bipolar mania in decades.”
Not quite a slam dunk
Shares gave back much of that early gain after Wells Fargo raised questions about safety and said it thinks the stock’s upside will be capped.
Agitation stands out: 16.7% of patients on RAP-219 reported it, against 9.4% on placebo (investigators judged most cases unrelated to the drug). And 24.6% of RAP-219 patients stopped treatment early, against 11.8% on placebo. For a drug whose pitch is that patients stay on it, that matters.
The efficacy is modest, too. In one of its mania trials, Vraylar beat placebo by about 6 points on the same scale over three weeks. (Different trials, different patients, but still.)
Of course, RAP-219’s edge grew every week, from 0.9 points at week one to 3.1 at week three, and Rapport plans to test a higher dose in Phase 3.
What’s next
Rapport plans to meet with the FDA in the first quarter of 2027 and start two Phase 3 trials in the second half.
It had $436.1 million in cash and short-term investments at the end of June, which it expects to last into the second half of 2029…
…though it burned $41.5 million of free cash flow in the June quarter, its most in two years:
My take: Bipolar mania gives RAP-219 a second shot on goal next to epilepsy, where it’s already in Phase 3, and I think that makes Rapport worth more even after today’s modest jump. I’d just want to see a wider edge over placebo at the higher dose.
So what is Rapport Therapeutics stock actually worth?
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