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CalciMedica Announces FDA Alignment on Phase 2b Trial Design for Auxora in Acute ...
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Fusion42 · 29 July 2026 · Fusion42 review
CalciMedica has secured FDA alignment on the design of its Phase 2b trial for Auxora, a treatment for acute pancreatitis. The agreement covers key trial endpoints and a biomarker-based patient selection strategy, establishing a potential regulatory pathway in a disease area with no currently approved therapies.
This Wire brief sits within Fusion42's coverage of Biotech.
◆ ◆ The Wire takeaway
The FDA is actively co-designing pivotal trials for diseases that lack any approved drugs. If you are developing a first-in-class therapy, your regulatory strategy should now include proposing novel endpoints and biomarker-driven patient selection, as CalciMedica has just proven is possible.
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1 source · 29 Jul 2026
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