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NovaBridge Says FDA Confirms Potential Eligibility of Gastric Cancer Drug for Accelerated Approval
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NovaBridge Says FDA Confirms Potential Eligibility of Gastric Cancer Drug for Accelerated Approval
Mar 16, 2026 6:20 AM

09:02 AM EDT, 03/16/2026 (MT Newswires) -- NovaBridge Biosciences ( NBP ) said Monday that, following a "productive" Type B meeting with the US Food and Drug Administration, the agency has confirmed the potential eligibility of its givastomig gastric cancer treatment for an accelerated approval pathway.

NovaBridge said it plans to initiate a late-stage registrational trial using objective response rate as a primary endpoint as early as Q4.

Early-stage trial data for the medication combined with immunochemotherapy demonstrated a 75% objective response rate alongside a 16.9-month median progression-free survival period, NovaBridge said.

Shares of the company were up over 10% in Monday premarket activity.

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