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CalciMedica Reports 2025 Financial Results and Provides Clinical Updates
Internal and external reviews of all available safety data from the Phase 2 KOURAGE trial in acute kidney injury (AKI) did not identify evidence of a
About this update from Calcimedica, Inc.
[{"type":"text","content":"Internal and external reviews of all available safety data from the Phase 2 KOURAGE trial in acute kidney injury (AKI) did not identify evidence of a drug-related toxicity with Auxora™Design of pivotal program in acute pancreatitis (AP) expected in 1H 2026JCI Insight publication of preclinical data demonstrates CM5480 as a potential differentiated therapy in pulmonary arterial hypertension (PAH); IND submission anticipated in 2027 LA JOLLA, Calif., March 3, 2026 /PRNewswire/ -- CalciMedica Inc. (\"CalciMedica\" or the \"Company\") (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today reported financial results for the year ended December 31, 2025 and provided clinical and corporate updates.\n \n \n \n \n \n \n \n\"First and foremost, in acute kidney injury, we and our external advisors have reviewed the unblinded KOURAGE data and have found no evidence of a drug-related toxicity. We look forward to discussions with the FDA about potential future clinical studies in AKI. We are also advancing Auxora towards the pivotal program in acute pancreatitis following constructive FDA engagement and the peer-reviewed publication of our Phase 2b CARPO results. The Company plans to finalize the design for this program in the first half of this year,\" said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. \"Concurrently, we continue to advance our second CRAC channel inhibitor, CM5480, in pulmonary arterial hypertension, following the recent publication of preclinical data which demonstrate its potential in cardiopulmonary disease.\"Recent Program Highlights:Acute Kidney Injury (AKI) with Acute Hypoxemic Respiratory Failure (AHRF) Program UpdatePhase 2 KOURAGE trial safety review: In January 2026, CalciMedica announced the discontinuation of the Phase 2 KOURAGE trial evaluating Auxora in patients with Stage 2 or Stage 3 AKI with associated AHRF. The decision followed a recommendation from the trial's Independent Data Monitoring Committee (IDMC) regarding a safety concern relating to a mortality imbalance that warranted reevaluation of the study design. The IDMC did not identify evidence of drug-related toxicity, and the Company's comprehensive review, performed in conjunct...