CALCIMEDICA Stock Price, News & Analysis

CalciMedica, Inc. (Nasdaq: CALC) is a clinical-stage biopharmaceutical company in the pharmaceutical preparation manufacturing industry. The company focuses on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses. According to company disclosures, its proprietary technology targets CRAC channels to modulate the immune response and protect against tissue cell injury, with the goal of addressing life-threatening inflammatory and immunologic diseases for which there are currently no approved therapies.

CalciMedica’s lead product candidate is Auxora™, described as a potent and selective small molecule CRAC channel inhibitor. Auxora has been formulated for intravenous administration and has been evaluated in multiple completed efficacy clinical trials. Across these studies, the company reports that Auxora has demonstrated positive and consistent clinical results and has been well-tolerated in over 350 critically ill patients who have received the drug. The development of Auxora is centered on conditions characterized by severe inflammation and direct tissue injury, where modulation of CRAC channels may help limit damage in organs such as the pancreas, lungs, and kidneys.

CalciMedica positions itself around a focused pipeline built on CRAC channel inhibition. In addition to Auxora, the company has disclosed a proprietary CRAC channel inhibitor candidate called CM5480. Preclinical data published in JCI Insight describe CM5480 as a potential first-in-class, differentiated therapy for pulmonary arterial hypertension (PAH), an indication marked by progressive pulmonary vascular disease and right ventricular dysfunction. In animal models of PAH, CM5480 was reported to restore or improve disease-affected pathways and functions, including heart contraction, cardiac output, gene expression profiles, DNA repair, and metabolism, and to reduce right ventricular dysfunction both as monotherapy and in combination with existing PAH therapies.

Auxora clinical programs span several serious conditions. CalciMedica has announced data from a Phase 2b trial known as CARPO (NCT04681066) in patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS). It has also reported data from a Phase 2 trial called CARDEA (NCT04345614) in patients with severe COVID pneumonia. These completed trials contribute to the company’s rationale for further development of Auxora in acute inflammatory settings.

The company is currently conducting a Phase 2 trial called KOURAGE (NCT06374797) in patients with acute kidney injury (AKI) with associated respiratory failure, including acute hypoxemic respiratory failure in certain descriptions. KOURAGE is described as a randomized, double-blind, placebo-controlled study in patients with Stage 2 or Stage 3 AKI and respiratory failure. The trial design includes daily dosing of Auxora or placebo and evaluation of outcomes such as days alive without the need for mechanical ventilation or dialysis, as well as composite kidney endpoints. CalciMedica has highlighted preclinical ischemia/reperfusion models of AKI in rats, where Auxora increased glomerular filtration rate and reduced renal injury, as part of the scientific basis for this program.

In AKI with respiratory failure, CalciMedica has reported mechanistic data suggesting that Auxora can reduce IL-17–related inflammation and IL-6–producing CD4 cells in animal models, with associated improvements in kidney function and histologic injury. The company links these findings to the clinical design of KOURAGE, noting that inclusion and exclusion criteria are intended to enrich for patients with elevated IL-17 levels, which have been associated with mortality and major adverse kidney events in severe AKI. This focus underscores the company’s strategy of using CRAC channel inhibition to modulate inflammatory pathways that contribute to multi-organ dysfunction.

For acute pancreatitis, CalciMedica has discussed positive regulatory interactions with the U.S. Food and Drug Administration (FDA) regarding the design of a pivotal trial in AP. The company has characterized this planned study as a pivotal trial in the United States for a therapeutic in AP and has linked the design to data from the CARPO trial. To support this effort, CalciMedica has entered into a collaboration with Telperian, a clinical trial intelligence company, to integrate Telperian’s artificial intelligence platform into analyses of completed Auxora clinical trials and simulations based on third-party data. The intent, as described by the company, is to refine target patient populations, efficacy endpoints, and overall trial design for Auxora in AP and to support ongoing regulatory discussions.

Beyond AP and AKI, CalciMedica has cited findings from the CARDEA trial in severe COVID pneumonia, including biomarker analyses showing reductions in D-dimer and other markers of systemic inflammation in patients treated with Auxora. These results are presented by the company as evidence of Auxora’s anti-inflammatory effects and potential endothelial stabilization, which it views as supportive of continued development in acute illnesses with a strong inflammatory component.

CalciMedica is headquartered in La Jolla, California, and its common stock is listed on The Nasdaq Capital Market under the trading symbol CALC, as indicated in its SEC filings. The company describes itself as a clinical-stage organization, meaning its product candidates are in clinical testing and have not received marketing approval. Its business model, as reflected in public statements and filings, centers on advancing CRAC channel inhibitors through clinical development in high-need inflammatory and immunologic indications, supported by preclinical research, clinical trial execution, regulatory engagement, and collaborations that apply advanced analytics to trial data.

According to its SEC reports, CalciMedica maintains an at-the-market equity offering program under an agreement with H.C. Wainwright & Co., allowing it to issue common stock up to a specified aggregate offering amount. The company has also disclosed a credit facility with a venture-focused lender, providing access to debt capital subject to milestones. These financing tools, together with periodic equity offerings, form part of the company’s approach to funding its clinical and corporate activities.

CalciMedica’s disclosures emphasize the risks and uncertainties inherent in clinical-stage biopharmaceutical development, including the possibility that clinical or preclinical results may not predict future outcomes, the need for regulatory approvals, safety considerations, market acceptance if approvals are obtained, intellectual property protection, and the company’s ongoing capital requirements. These factors are discussed in more detail in its periodic reports and risk factor sections filed with the U.S. Securities and Exchange Commission.