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CalciMedica, Inc. develops calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory and immunologic diseases. The clinical-stage biopharmaceutical company’s lead product candidate, Auxora, is an intravenous small-molecule CRAC channel inhibitor based on zegocractin and is being studied across severe inflammatory conditions involving tissue cell injury.
Company news commonly covers financial results, clinical and preclinical updates, regulatory discussions, publications, and corporate developments. Recurring program topics include Auxora data in acute pancreatitis with systemic inflammatory response syndrome, severe COVID-19 pneumonia, and acute kidney injury, as well as preclinical work on CM5480 in pulmonary arterial hypertension.
CalciMedica (Nasdaq: CALC) reported alignment with the U.S. FDA on the design of its planned Phase 2b trial of Auxora™ in acute pancreatitis (AP), including new-onset severe respiratory failure as the primary endpoint and multi-organ failure and time to medically indicated discharge as key secondary endpoints.
FDA and CalciMedica also aligned on using the Phase 2b study to refine patient selection and inform the Phase 3 registrational endpoint strategy. The trial will prospectively evaluate elevated lactate dehydrogenase (LDH) as a potential enrichment marker, supported by CARPO data linking LDH >240 U/L to higher IL-6 and more respiratory failure events. In CARPO, medium and high Auxora doses showed a 100% reduction in new-onset severe respiratory failure versus placebo. Auxora has been tested in >350 patients across AP, COVID-19 pneumonia (CARDEA, 56% 30‑day mortality reduction) and AKI with respiratory failure (KOURAGE), and is also being advanced toward studies in pulmonary arterial hypertension.
CalciMedica (Nasdaq: CALC) entered a securities purchase agreement for a private placement of up to approximately $49 million in gross proceeds. The company expects upfront proceeds of about $15 million, extending its cash runway into 2H 2027.
Funding will support a focused pulmonary hypertension strategy, including a Phase 1b proof-of-concept study of Auxora in PAH with data anticipated mid-2027, and advancement of oral CRAC inhibitor CM5480 toward IND clearance, also expected mid-2027.
CalciMedica (Nasdaq: CALC) reported that the FDA has reviewed a protocol amendment and interim safety data from the Phase 2 KOURAGE trial of Auxora in Stage 2/3 AKI with AHRF and provided no comments, allowing dosing to continue.
An Independent Data Monitoring Committee had previously prompted a pause in enrollment due to a mortality imbalance, though no drug-related toxicity was identified. A safety review of 107 dosed patients found serious adverse events consistent with prior Auxora experience. CalciMedica also anticipates FDA feedback in Q3 2026 on a potential pivotal Auxora program in acute pancreatitis.
CalciMedica (Nasdaq: CALC) reported Q1 2026 results and pipeline updates. Cash was $8.2 million, expected to fund operations into 4Q 2026. Q1 net income was $5.0 million versus a $5.0 million loss a year ago, driven by higher other income.
CalciMedica expects FDA feedback in 2Q 2026 on the pivotal Auxora program in acute pancreatitis and potential future development in acute kidney injury. Phase 2b CARPO results in AP showed dose-dependent improvements in several clinical endpoints. Preclinical and IND-enabling work for oral CRAC inhibitor CM5480 in pulmonary hypertension continues, with an IND submission anticipated in 2027.
CalciMedica (Nasdaq: CALC) reported 2025 results and clinical updates on March 3, 2026. Cash and equivalents were $13.0M, expected to fund operations into Q4 2026. Net loss was $29.6M ($1.97/share) versus $13.7M ($1.22/share) in 2024.
Clinically, the Phase 2 KOURAGE AKI trial was discontinued following an IDMC recommendation related to a mortality imbalance; reviews found no drug-related toxicity. The company expects FDA discussions on KOURAGE in Q2 2026 and plans to finalize a pivotal acute pancreatitis program in 1H 2026. Preclinical CM5480 PAH data were published, with an IND anticipated in 2027.
CalciMedica (Nasdaq: CALC) has discontinued the Phase 2 KOURAGE trial of Auxora in Stage 2–3 acute kidney injury (AKI) with associated acute hypoxemic respiratory failure after an Independent Data Monitoring Committee (IDMC) recommended reevaluation for a safety concern related to study design and enrollment criteria.
The company said no deaths were judged related to study drug and no serious adverse events required expedited FDA reporting. CalciMedica will review unblinded data, assess baseline and treatment factors, notify the FDA, complete 90-day follow-up for enrolled patients, and consider modified future AKI trials while progressing other programs including a pivotal acute pancreatitis trial planning in H1 2026 and CM5480 development.
CalciMedica (NASDAQ: CALC) reported third-quarter 2025 results and clinical updates. Key points: cash, cash equivalents and short-term investments $14.1M, expected to fund operations into the second half of 2026. Enrollment is ongoing in the randomized Phase 2 KOURAGE trial (target n=150) of Auxora in Stage 2–3 AKI with respiratory failure, with data expected in 1H 2026. CalciMedica reported constructive FDA discussions on a pivotal acute pancreatitis trial, with final design expected in 1H 2026, and announced an October 2025 collaboration with Telperian to apply AI to completed Auxora trial data. Preclinical work published in JCI Insight supports CRAC inhibition in PAH and right ventricular dysfunction. Q3 results: R&D $3.9M, G&A $1.8M, other expenses $2.2M, and net loss $7.8M ($0.52 per share).
CalciMedica (Nasdaq: CALC) announced publication in JCI Insight of preclinical data for its CRAC channel inhibitor CM5480, showing benefit in a monocrotaline (MCT) rat model of pulmonary arterial hypertension (PAH).
Key findings: daily CM5480 at 20 mg/kg reduced pulmonary neomuscularization, right ventricular systolic pressure (RVSP), pulmonary vascular resistance (PVR) and RV hypertrophy; CM5480 restored heart contraction, cardiac output and several disease‑linked gene and metabolic pathways. Combination therapy with ambrisentan or sildenafil produced greater improvements than either SOC agent alone. Authors include CalciMedica leaders and PAH researchers from Inserm and Université Paris‑Saclay.
The release links these results to CalciMedica's lead program Auxora and the ongoing Phase 2 KOURAGE trial in AKI, with data expected in 1H 2026.
CalciMedica (NASDAQ: CALC) presented preclinical data at ASN Kidney Week 2025 showing that three-day IV dosing of Auxora (16 mg/kg) in a rat ischemia/reperfusion AKI model reduced kidney Th‑17 cells by 64% versus placebo and lung Th‑17 cells by 59% (each p<0.05).
Auxora also decreased IL‑6–producing CD4 cells in lung by 69% (p<0.05), produced greater GFR recovery (p<0.01), lower serum creatinine (p<0.05) at 72 hours, and reduced tubular injury by >50% versus placebo. Findings support the mechanistic rationale for Auxora in severe AKI with acute hypoxemic respiratory failure and align with the ongoing Phase 2 KOURAGE trial targeting patients with elevated IL‑17.
CalciMedica (NASDAQ: CALC) announced a collaboration with Telperian to integrate Telperian's AI engine into analysis of completed Phase 2 clinical trial datasets for Auxora, including the CARPO (acute pancreatitis with SIRS) and CARDEA (severe COVID-19 pneumonia) trials.
Telperian will apply AI, biostatistics, subtyping, and historical-study emulations to refine target patient subgroups, efficacy endpoints, and to generate data-supported insights to support CalciMedica's regulatory discussions with the FDA for a final pivotal trial design in acute pancreatitis. Auxora is also being evaluated in the Phase 2 KOURAGE trial, with data expected in early 2026.