NovaBridge Reports FY2025 Results and FDA Alignment on Accelerated Approval Path for Givastomig

NovaBridge Biosciences reported full-year 2025 financial results and provided a significant pipeline update. The company ended 2025 with $210.8 million in cash, providing a runway through 2028. Research and development expenses rose to $62.9 million, primarily due to IPR&D costs from the acquisition of VIS-101. The net loss attributable to NovaBridge was $46.3 million. Key pipeline progress includes givastomig, a CLDN18.2 X 4-1BB bispecific antibody for gastric cancer, which demonstrated a 75% objective response rate (ORR) and 16.9-month median progression-free survival (mPFS) in Phase 1b. Following a Type B meeting, the FDA confirmed givastomig's potential eligibility for the Accelerated Approval Pathway, with a registrational Phase 3 trial expected to initiate as early as Q4 2026. Additionally, VIS-101 for wet AMD showed robust durability in Phase 2a, with roughly half of patients remaining retreatment-free at six months; a Phase 2b study is slated for H2 2026. The company also announced several executive appointments and the formation of its subsidiary, Visara, to advance its "hub-and-spoke" platform model.