NovaBridge gains FDA fast track status for bispecific antibody givastomig

• NovaBridge Biosciences received FDA Fast Track Designation for its advanced gastric cancer combination therapy.
• The company's share price increased 12.93% to $1.66 following the regulatory announcement.
• The expedited status will support the planned initiation of a registrational Phase 3 trial in late 2026.

NovaBridge Biosciences (NASDAQ:NBP) received FDA Fast Track Designation for its bispecific antibody givastomig to treat advanced gastric adenocarcinoma expressing Claudin 18.2 protein levels.

This regulatory milestone follows an earlier confirmation from the agency regarding accelerated approval pathway eligibility for the therapeutic candidate.

The experimental drug regimen evaluates the compound alongside nivolumab and standard chemotherapy in previously untreated HER2-negative patients.

The clinical-stage company concentrates on engineering multi-specific biologics designed to overcome immunosuppressive environments in solid tumors.

The biotechnology firm expects to initiate enrollment for a global, registrational Phase 3 clinical trial as early as the fourth quarter of 2026.