NovaBridge had ‘productive’ FDA meeting on potential gastric cancer treatment

The company states: “NovaBridge (NBP) Biosciences announced that based on a productive Type B meeting with the U.S. Food and Drug Administration and receipt of written minutes, NovaBridge has secured FDA alignment on givastomig’s potential eligibility for an accelerated approval pathway in 1L Her2-, CLDN 18.2+, PD-L1+ GEC patients, building on positive data from the Phase 1b combination trial. The Company intends to initiate a registrational Phase 3 trial, in combination with immunochemotherapy, as early as Q4 2026. Final study design details will be discussed with FDA.”