other material
confidence high
sentiment negative
materiality 0.70
Imsidolimab HARP Phase 2 fails to beat placebo in hidradenitis suppurativa; HS development halted
ANAPTYSBIO, INC
- Imsidolimab did not improve primary endpoint (AN count change) or HiSCR50 vs placebo at Week 16 in moderate-to-severe HS.
- No imsidolimab-related serious/severe AEs; safety profile acceptable across arms.
- Company discontinues imsidolimab development in HS; GEMINI-1 Phase 3 for GPP continues with data expected Q4 2023.
- Plans to outlicense imsidolimab prior to potential FDA approval for GPP; focus on rosnilimab and ANB032 immune cell modulators.
- Cash over $570M at Q2 end; AZURE Phase 2 rosnilimab data in alopecia areata anticipated Q1 2023.