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GlobeNewsWire
3 months ago
NovaBridge Announces Productive FDA Type B Meeting on Potential Accelerated Approval Pathway for Givastomig in Gastric Cancer
FDA confirmed givastomig's potential eligibility for an accelerated approval pathway NovaBridge expects to initiate a registrational Phase 3 combination trial as early as Q4 2026, using objective response rate (ORR) as a primary endpoint for accelerated approval Givastomig, a bispecific Claudin 18.2 X 4-1BB antibody, has the potential to be a first-in-class and best-in-class first line (1L) Claudin 18.2 (CLDN 18.2) therapeutic in Her-2 negative (Her2-), CLDN 18.2 positive (CLDN 18.2+), PD-L1-positive (PD-L1+) gastroesophageal cancer (GEC) ROCKVILLE, Md., March 16, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (“NovaBridge” or the “Company”), a global biotechnology platform company committed to accelerating access to innovative medicines, today announced that based on a productive Type B meeting with the U.S. Food and Drug Administration (the “FDA”) 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.
