CALCIMEDICA INC Stock Price, News & Analysis

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.

CalciMedica (NASDAQ:CALC), a clinical-stage biopharmaceutical company developing CRAC channel inhibition therapies, announced its participation in the upcoming H.C. Wainwright Global Investment Conference. CEO Rachel Leheny, Ph.D. will present on September 8, 2025, at 3:30 p.m. ET.

The presentation will be available via live webcast in the "IR Events and Presentations" section of CalciMedica's website, with a replay accessible for 90 days following the event.

CalciMedica (NASDAQ:CALC) reported Q2 2025 financial results and provided updates on its clinical programs. The company reported a net loss of $6.0 million ($0.40 per share), compared to $4.0 million in Q2 2024. Cash position stands at $18.0 million, expected to fund operations into mid-2026.

Key clinical developments include ongoing enrollment in the Phase 2 KOURAGE trial of Auxora™ for acute kidney injury (AKI) with respiratory failure, with data expected in early 2026. The company also held a productive initial FDA meeting regarding Auxora in acute pancreatitis (AP), with pivotal trial alignment anticipated by end of 2025.

R&D expenses decreased slightly to $4.1 million from $4.2 million year-over-year, while G&A expenses increased to $2.6 million from $2.4 million.

CalciMedica (Nasdaq: CALC), a clinical-stage biopharmaceutical company specializing in CRAC channel inhibition therapies, announced its participation in the upcoming H.C. Wainwright 4th Annual Kidney Virtual Conference. CEO Rachel Leheny, Ph.D. will engage in a fireside chat on July 14, 2025, at 2:00 p.m. ET.

The presentation will be accessible through a live webcast in the "IR Events and Presentations" section of CalciMedica's investor relations website, with a replay available for 90 days following the event.

CalciMedica (NASDAQ:CALC) announced the publication of a manuscript in the American Journal of Nephrology detailing the design and rationale of their Phase 2 KOURAGE trial for Auxora™ in acute kidney injury (AKI) with respiratory failure. The publication includes promising preclinical data and a post-hoc analysis from the CARDEA trial.

Key findings include: 62.7% relative reduction and 29.3% absolute reduction in mortality for Auxora versus placebo in AKI patients from the CARDEA trial. The drug showed significant benefits in preclinical models, increasing glomerular filtration rate and preventing mortality. The research addresses a critical medical need, as approximately 3.7 million patients are hospitalized with AKI annually in the U.S., with a 50% mortality rate for severe cases with respiratory failure.

CalciMedica announced an upcoming symposium titled 'Auxora for the Treatment of AKI' at the 43rd Vicenza Course AKI-CRRT-EBPT and Critical Care Nephrology meeting in Vicenza, Italy from June 24-26. The symposium will feature three presentations: Dr. Sudarshan Hebbar will discuss CRAC Channels, Dr. Javier Neyra will present on IL-17's role in AKI pathophysiology, and Dr. Lakhmir Chawla will cover the KOURAGE study. The presentations will be available as webcasts on CalciMedica's IR website after the sessions. The company focuses on developing CRAC channel inhibition therapies for inflammatory and immunologic illnesses.

CalciMedica (NASDAQ: CALC) reported Q1 2025 financial results and provided clinical updates. The company continues enrollment in its Phase 2 KOURAGE trial of Auxora™ for acute kidney injury (AKI) with respiratory failure, with data expected by end of 2025. A post-hoc analysis of AKI patients from the Phase 2 CARDEA trial showed a significant 62.7% relative reduction in mortality for Auxora versus placebo. The company's cash position of $24.6 million, along with a new credit facility of up to $32.5 million from Avenue Capital Group, is expected to fund operations into mid-2026. Q1 2025 financial results showed R&D expenses of $4.2 million (up from $2.9M in Q1 2024) and a net loss of $5.0 million. CalciMedica plans an end-of-Phase 2 FDA meeting mid-2025 and aims to initiate a Phase 3 program in acute pancreatitis with SIRS by year-end, pending funding.