BLA Submission

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.

Summit Therapeutics plans a Q4 2025 BLA submission for ivonescimab plus chemotherapy in EGFR-mutated NSCLC based on positive Phase III HARMONi trial results. A new Phase III CRC study (HARMONi-GI3) will begin, with more Phase III trials planned. HARMONi showed a 48% reduction in disease progression risk in NSCLC and the HARMONi-6 study in China demonstrated a 40% reduction in risk in squamous NSCLC compared to tislelizumab plus chemotherapy. The HARMONi-3 study will analyze squamous and non-squamous NSCLC cohorts separately.