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FDA Aligns Auxora Phase 2b Endpoints and LDH Enrichment for Acute Pancreatitis

Jul 29, 2026, 7:06 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Regulatory-aligned endpoints reduce execution risk and may accelerate development timelines, potentially supporting a re-rating if Phase 2b progresses smoothly toward Phase 3.

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What happened, with direct paths to the underlying reporting

CalciMedica announced FDA alignment on Phase 2b endpoints for Auxora in acute pancreatitis, including new-onset severe respiratory failure as the primary endpoint and LDH-based enrichment under evaluation. The plan could guide a well-powered Phase 3 program if Phase 2b results are favorable, potentially delivering the first U.S. pivotal trial for AP.

FDA aligns Phase 2b endpoints for Auxora in acute pancreatitis.
LDH enrichment marker to identify higher-risk patients.
CARPO trial: medium/high Auxora doses reduced new-onset severe respiratory failure 100%.
Phase 2b design will inform Phase 3 endpoints and patient selection.
AP lacks approved therapies; potential first pivotal U.S. program.

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FDA Aligns Auxora Phase 2b Endpoints and LDH Enrichment for Acute Pancreatitis

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