LA JOLLA, Calif., Nov. 03, 2026 (GLOBE NEWSWIRE) -- CalciMedica, Inc. ("CalciMedica" or the "Company") (NASDAQ:CALC), a clinical-stage biopharmaceutical company developing novel calcium
LA JOLLA, Calif., Sept. 08, 2026 (GLOBE NEWSWIRE) -- CalciMedica, Inc. ("CalciMedica" or the "Company") (NASDAQ:CALC), a clinical-stage biopharmaceutical company developing novel calcium
LA JOLLA, Calif., Aug. 27, 2026 (GLOBE NEWSWIRE) -- CalciMedica Inc. ("CalciMedica" or the "Company") (NASDAQ:CALC), a clinical-stage biopharmaceutical company developing novel calcium
Completed private placement financing of up to approximately $49 million to advance pulmonary hypertension program Auxora Phase 1b proof-of-concept data in pulmonary arterial hypertension (PAH) and CM5480 IND
FDA aligned on new-onset severe respiratory failure as the Phase 2b primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpointsFDA aligned on a strategy to evaluate
Proceeds expected to support a focused pulmonary hypertension strategy, including a Phase 1b proof-of-concept study evaluating Auxora™ in PAH, with data anticipated mid-2027, and advancement of oral CRAC channel
FDA reviewed a protocol amendment and interim safety data from the KOURAGE trial evaluating Auxora in AKI patientsNo comments or questions were receivedConfirms CalciMedica's ability to continue clinical development
FDA feedback on the Auxora™ pivotal program in acute pancreatitis and potential future development in acute kidney injury expected in 2Q 2026 Preclinical and IND-enabling studies advancing for CM5480, an oral CRAC
Internal and external reviews of all available safety data from the Phase 2 KOURAGE trial in acute kidney injury (AKI) did not identify evidence of a drug-related toxicity with Auxora™Design of pivotal program in
Safety concern warrants reevaluation of study design, including enrollment criteria
Potential future trial with Auxora™ in AKI to be evaluated after data analysis
LA JOLLA, Calif., Jan. 28, 2026 /PRNewswire/ --
Enrollment ongoing in Phase 2 KOURAGE trial of Auxora™ in acute kidney injury (AKI) with respiratory failure; data expected in 1H 2026
Positive discussions with FDA on pivotal trial in acute pancreatitis (AP);
Preclinical data support CRAC channel inhibitor, CM5480, as a potential first-in-class, differentiated therapy for pulmonary arterial hypertension (PAH), both as monotherapy and in combination with existing
Treatment with Auxora significantly reduced IL-17–related inflammation in both kidney and lung, significantly increased glomerular filtration rate (GFR), and decreased renal injury in a rat model of AKI
Findings
AI tools will allow CalciMedica to analyze Phase 2 datasets to refine the target patient populations and efficacy endpoints for upcoming pivotal trials
LA JOLLA, Calif., Oct. 14, 2025 /PRNewswire/ -- CalciMedica Inc.
LA JOLLA, Calif., Sept. 2, 2025 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (NASDAQ:CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium
