I-Mab Picks Givastomig Dose After Promising Gastric Cancer Data, Aligns With FDA

Impact · against what's priced in

I-Mab (NBP) shares a positive catalyst following strong Phase 1b efficacy data for givastomig, characterized by high objective response rates (75-82%) and promising durability (15.2 months median DoR). The achievement of FDA alignment on a global registrational study protocol provides a clear regulatory pathway toward potential accelerated approval.

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In context

The report of 82% ORR in high CLDN18.2 expression patients and the formal agreement with the FDA on a registrational study protocol are significant milestones for a clinical-stage asset.

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• biotech
• NBP
• clinical trials
• drug development
• fda
• gastric cancer
• immunotherapy
• oncology
• phase 1b

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