other material
confidence high
sentiment positive
materiality 0.80
AnaptysBio reports Phase 2b RA trial success; rosnilimab hits primary endpoint, 69% CDAI LDA at week 14
ANAPTYSBIO, INC
- Phase 2b RENOIR trial (n=424) met primary endpoint (mean DAS-28 CRP change at week 12) across all three doses vs placebo (p<0.01).
- At week 14, 69% of rosnilimab-treated patients achieved CDAI low disease activity, described as highest ever reported.
- Favorable safety: no malignancies, no MACE, no serious infection elevation vs placebo; discontinuations low at 1-2%.
- Full week 28 data expected Q2 2025; top-line week 12 rosnilimab UC data now anticipated in Q4 2025.
- CEO states results exceed target product profile in ~$20B U.S. RA market.