NovaBridge Biosciences Receives Positive Regulatory Feedback From The U.S. Food And Drug Administration (FDA) On Accelerated Approval Pathway For Givastomig

NovaBridge Biosciences (Nasdaq: NBP), a global biotechnology platform company working to accelerate access to innovative medicines, announced that it has received positive regulatory feedback from the U.S. Food and Drug Administration (FDA). After a productive Type B meeting and review of the official written minutes, the FDA agreed that givastomig may be eligible for an accelerated approval pathway for first-line Her2-, CLDN 18.2+, PD-L1+ gastroesophageal cancer patients. This alignment builds on strong results from the Company’s Phase 1b combination study. NovaBridge plans to begin a registrational Phase 3 trial using givastomig alongside immunochemotherapy as early as the fourth quarter of 2026, with final study design details to be further discussed with the FDA. Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge, stated that the FDA’s feedback represents an important regulatory milestone. He noted that the Phase 1b results demonstrated compelling efficacy and generally favorable tolerability, comparing positively to historical standards of care. According to Dr. Dennis, givastomig has strong potential to become a first-in-class and best-in-class Claudin 18.2 therapeutic for gastric cancer when used in combination with immunochemotherapy. He emphasized that the Company remains committed to advancing discussions with the FDA and moving the therapy toward patients as quickly as possible. The Phase 1b dose escalation and expansion combination study, as previously summarized in NovaBridge’s January 6, 2026 update, showed that givastomig, administered at 8 mg/kg and 12 mg/kg every two weeks, produced a 75% objective response rate across evaluable patients. The study reported a 77% response rate at the lower dose and 73% at the higher dose across 52 evaluable patients. Responses were seen across a broad range of PD-L1 and CLDN18.2 expression levels, and the treatment demonstrated meaningful durability, with a median progression-free survival of 16.9 months and an 82% six-month progression-free survival rate in 53 evaluable patients. The combination also showed good overall tolerability without evidence of dose-dependent toxicity. More detailed data from the Phase 1b expansion study will be presented at a major medical conference in the second half of 2026. NovaBridge continues to advance the development of givastomig as it prepares for Phase 3 evaluation and works toward delivering new therapeutic options for patients with gastric cancer.