• Registrational Phase 3 Trial Expected to Begin as Early as Q4 2026
  • Detailed Phase 1b Data Expected to be Presented at a Major Medical Conference in H2 2026

ROCKVILLE, Md., June 16, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (NASDAQ:NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines that address significant unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to givastomig in combination with nivolumab and chemotherapy for the treatment of patients with previously untreated HER2-negative advanced or metastatic gastroesophageal adenocarcinomas (GEA) whose tumors are both Claudin 18.2 (CLDN18.2) and PD-L1 positive. Givastomig is a novel CLDN18.2 x 4-1BB bispecific antibody.

Phase 1b data demonstrated compelling efficacy and tolerability for givastomig in combination with immunochemotherapy, supporting its potential as a premier CLDN18.2-directed therapy for gastric cancer. Fast Track Designation is intended to accelerate development and review of therapies for serious conditions with unmet medical need.