Atacicept

Vera Therapeutics (VERA) submitted a BLA to the FDA for accelerated approval of atacicept for IgAN, supported by Phase 3 ORIGIN 3 interim data. The analysis showed a 46% reduction from baseline and a 42% reduction versus placebo in 24-hour UPCR at week 36. The safety profile was reportedly comparable to placebo. The ORIGIN 3 trial, involving 431 adults, continues to assess eGFR, with study completion expected in 2027. Atacicept, if approved, would be the first dual BAFF/APRIL modulator for IgAN.