Calcimedica - FDA provides no comments, Calcimedica to continue Auxora development across indications

CalciMedica (Nasdaq: CALC) has announced that it will continue the development of its lead product candidate, Auxora™, across multiple indications following the absence of comments from the U.S. Food and Drug Administration (FDA) on its proposed pivotal program in acute pancreatitis (AP) and potential future development in acute kidney injury (AKI) as of June 2026. The company remains focused on advancing its pipeline of calcium release-activated calcium (CRAC) channel inhibitors for inflammatory, immunologic, and cardiopulmonary diseases with high unmet medical needs.

In the AP program, CalciMedica has engaged constructively with the FDA regarding the design of a potential pivotal trial for Auxora. The company expects to finalize the pivotal program in the first half of 2026. Positive results from the Phase 2b CARPO trial, published in eClinicalMedicine in February 2026, demonstrated dose-dependent improvements in multiple endpoints, including reductions in organ failure and time to medically indicated discharge. The high-dose Auxora arm achieved a statistically significant stratified win ratio of 1.640 (p < 0.05), indicating a favorable clinical outcome compared to placebo.

In the AKI program, the Phase 2 KOURAGE trial was paused in January 2026 following a recommendation from the Independent Data Monitoring Committee (IDMC) due to a mortality imbalance. However, internal and external reviews of the available safety data did not identify evidence of drug-related toxicity. CalciMedica plans to discuss the KOURAGE dataset with the FDA in the second quarter of 2026 to explore potential future development in AKI.

Financially, as of March 31, 2026, CalciMedica reported cash and cash equivalents of $8.2 million, which the company expects to fund operations into Q4 2026. Research and development expenses for the first quarter of 2026 were $3.5 million, a decrease from $4.2 million in the same period in 2025, primarily due to reduced preclinical and clinical trial activities. General and administrative expenses were $2.1 million for the first quarter of 2026, compared to $2.3 million in the first quarter of 2025. The company reported net income of $5.0 million for the first quarter of 2026, compared to a net loss of $5.0 million in the same period in 2025.

CalciMedica is also advancing its next-generation CRAC channel inhibitor, CM5480, for chronic inflammatory, immunologic, and cardiopulmonary diseases. Preclinical data published in JCI Insight in November 2025 demonstrated the potential of CM5480 in pulmonary arterial hypertension (PAH), with plans for an IND submission in 2027.

The company’s strategy remains centered on leveraging its proprietary CRAC channel inhibition technology to address serious diseases with limited therapeutic options. With a cash runway extending into late 2026 and ongoing discussions with regulatory authorities, CalciMedica is positioned to continue its development efforts across its pipeline.