CalciMedica, Inc. CALC
CalciMedica, Inc. (Nasdaq: CALC) is a GI/hepatology drug developer. Its lead program, Auxora (zegocractin), is in Phase 2 for acute pancreatitis (with SIRS); also AKI with AHRF. Its next catalyst on record is Auxora: Phase 1b proof-of-concept data in PAH (2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Auxora — Phase 1b proof-of-concept data in PAH (2027). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Auxora (zegocractin) | acute pancreatitis | small molecule | Phase 2 |
| Auxora (zegocractin) | acute kidney injury with acute hypoxemic respiratory failure (KOURAGE) | small molecule | Phase 2 |
| Auxora (zegocractin) | pulmonary arterial hypertension | small molecule | Phase 1 |
| CM5480 | pulmonary hypertension (PAH, CpcPH-HFpEF) | small molecule | Pre-clinical |
Recent results and decisions
- Jul 29, 2026n/a Following a Type C meeting, FDA aligned that the Phase 2b acute pancreatitis trial primary endpoint will be new-onset severe respiratory failure; trial start subject to additional financing.
FDA aligned that the primary endpoint for the Phase 2b trial in acute pancreatitis will measure whether Auxora can reduce new-onset severe respiratory failure
Filing - Mar 3, 2026n/a Internal and external reviews of unblinded KOURAGE data found no evidence of drug-related toxicity; the safety concern was a mortality imbalance, possibly from baseline severity imbalance; FDA discussion planned Q2 2026.
Imbalances in the patients’ severity of disease at baseline may have contributed to the observed safety concern.
Filing - Jan 28, 2026discontinued CalciMedica discontinued the Phase 2 KOURAGE trial after the IDMC identified a safety concern at a prescheduled interim review; no deaths assessed as drug-related.
During a prescheduled interim data review, the IDMC identified a safety concern that, in its view, warrants reevaluation of the study design, particularly with respect to patient enrollment criteria.
Filing
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