Dual Phase 3 wins in HS and PsA position sonelokimab for multi-indication filing — BLA acceptance and label scope are the make-or-break conditions

MoonLake Immunotherapeutics is a clinical-stage company developing sonelokimab, a targeted therapy for hidradenitis suppurativa and psoriatic arthritis, which is not yet approved.

Sonelokimab, a nanobody blocking IL-17A and IL-17F in inflammatory skin and joint disease, has now met primary endpoints across four Phase 3 trials spanning hidradenitis suppurativa, psoriatic arthritis, and adolescents. The single binary is whether FDA accepts the BLA and grants a label broad enough to compete against established IL-17 and IL-23 inhibitors, given VELA-2's primary endpoint miss on the composite strategy. The VELA-2 composite failure introduces an unusual approval-path question that the FDA pre-BLA alignment partially mitigated but did not eliminate.