CalciMedica Inc. (NASDAQ:CALC) suffered a dramatic market reaction on Wednesday as its shares plunged about 80% following an announcement that the company would discontinue its Phase 2 KOURAGE trial for acute kidney injury (AKI). The decision followed a scheduled interim review by an Independent Data Monitoring Committee (IDMC), which identified safety concerns and recommended that the study be halted.
The La Jolla, California-based biopharmaceutical firm said the IDMC advised pausing the trial to allow a reassessment of the study design, with a particular focus on patient enrollment criteria. The trial had been evaluating Auxora, CalciMedica’s calcium release-activated calcium channel inhibitor, in patients with Stage 2 or Stage 3 acute kidney injury who also had acute hypoxemic respiratory failure.
CalciMedica emphasized that, in the course of the trial, no deaths were judged to be related to Auxora, and there were no serious adverse events that required expedited reporting to the U.S. Food and Drug Administration. Nonetheless, the IDMC’s safety observations prompted the company to stop enrollment and analyze the accumulated data in depth.
The company outlined plans to undertake a comprehensive review of the unblinded KOURAGE data. That analysis will examine baseline characteristics of enrolled patients, the severity of disease at presentation, and concomitant therapies that might have influenced clinical outcomes. According to CalciMedica, insights from that review will guide decisions about any future clinical testing of Auxora in AKI.
Reflecting the company’s stated next steps, Rachel Leheny, Ph.D., CEO of CalciMedica, said: "Based on the IDMC’s feedback, we will review the unblinded KOURAGE data and explore modifications to the trial design, particularly patient enrollment criteria, that may support further clinical testing of Auxora in patients with AKI."
While pausing the KOURAGE trial, CalciMedica said it remains positive about the broader potential for Auxora in acute inflammatory illnesses. The company also indicated plans to finalize the design of a pivotal trial in acute pancreatitis in the first half of 2026.
The abrupt halt and the sharp decline in the company’s share price underscore the immediate market sensitivity to safety signals identified during mid-trial reviews. CalciMedica’s publicly stated focus now is on detailed data evaluation and potential redesign of enrollment criteria to determine whether Auxora can be tested further in AKI populations.
Context and next steps
- CalciMedica has paused the Phase 2 KOURAGE trial following an IDMC recommendation during an interim review.
- The company will perform a comprehensive review of unblinded clinical data to assess factors that may have affected outcomes.
- No trial deaths were assessed as related to Auxora, and no serious adverse events required expedited FDA reporting, according to the company.