Rapport Therapeutics reports positive Phase 2 results for RAP‑219 in bipolar mania
Rapport Therapeutics announced that its Phase 2 trial of RAP‑219 met both the primary Young Mania Rating Scale (YMRS) endpoint and the secondary CGI‑BP mania severity endpoint. The drug produced a 3.1‑point placebo‑adjusted improvement on the YMRS at Week 3 and a 0.4‑point improvement on the CGI‑BP score. Safety was acceptable, with all treatment‑emergent adverse events mild or moderate and no serious events reported. The company said it will discuss Phase 3 plans with the FDA in early 2027 and expects to begin Phase 3 trials in the second half of 2027.
Why it matters
The results provide clinical proof‑of‑concept for RAP‑219, supporting the company’s plan to advance to Phase 3 and potentially capture a multibillion‑dollar bipolar mania market. The company disclosed $436.1 million of cash as of June 30 2026, which it expects to fund operations into the second half of 2029.
Key facts
- 1The trial met the primary YMRS endpoint with a 3.1‑point placebo‑adjusted improvement at Week 3 (p=0.045). stocktitan.net
- 2The trial met the secondary CGI‑BP mania severity endpoint with a 0.4‑point placebo‑adjusted improvement (p=0.024). stocktitan.net
- 3RAP‑219‑treated patients showed a mean 15.4‑point reduction in YMRS total score from baseline at Week 3. stocktitan.net
- 4All treatment‑emergent adverse events were mild or moderate; no serious adverse events occurred. stocktitan.net
- 5The study enrolled 253 adults with bipolar I disorder. sec.gov
- 6Rapport plans to meet the FDA in Q1 2027 and start Phase 3 trials in H2 2027. investing.com
Summary written by AlphAI AI Desk from 13 of 13 sources. Not investment advice. Figures are as stated by the linked sources.