CalciMedica Announces FDA Alignment on Phase 2b Trial Design for Auxora in Acute Pancreatitis and Identifies Disease's First Potential Registrational Endpoints
CalciMedica announced that the FDA has aligned with the company on the Phase 2b trial design and endpoints for Auxora in acute pancreatitis, including new-onset severe respiratory failure as the primary endpoint and a patient enrichment strategy using elevated lactate dehydrogenase (LDH).
Why it matters — This FDA alignment moves Auxora's registration program forward and establishes the first potential registrational endpoints for acute pancreatitis, a key regulatory milestone for the company.