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CalciMedica (CALC)

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Earnings summaries and quarterly performance for CalciMedica.

Research analysts covering CalciMedica.

Recent press releases and 8-K filings for CALC.

CalciMedica Discontinues Phase 2 KOURAGE Trial
CALC
New Projects/Investments
  • CalciMedica Inc. announced the discontinuation of its Phase 2 KOURAGE clinical trial evaluating Auxora in patients with acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF).
  • The decision was based on a recommendation from the Independent Data Monitoring Committee (IDMC), which identified a safety concern warranting reevaluation of the study design and patient enrollment criteria.
  • Despite the discontinuation, no deaths were assessed by investigators or CalciMedica as being related to the study drug, and no serious adverse events met criteria for expedited reporting to the U.S. Food and Drug Administration (FDA).
  • The company plans to perform a comprehensive review of the unblinded clinical data to inform how future clinical evaluation of Auxora in AKI may proceed.
  • CalciMedica remains optimistic about Auxora's potential in other acute inflammatory illnesses and expects to finalize the design of a pivotal trial in acute pancreatitis (AP) in the first half of 2026.
Jan 28, 2026, 12:06 PM
CalciMedica discontinues Phase 2 KOURAGE trial
CALC
New Projects/Investments
  • CalciMedica (Nasdaq: CALC) has discontinued its Phase 2 KOURAGE clinical trial evaluating Auxora™ in patients with Stage 2 or Stage 3 acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF).
  • The decision was based on a recommendation from the Independent Data Monitoring Committee (IDMC), which identified a safety concern during a prescheduled interim data review, warranting reevaluation of the study design and patient enrollment criteria.
  • Despite the IDMC's recommendation, no deaths in the trial were assessed as related to the study drug, and no serious adverse events met criteria for expedited reporting to the U.S. Food and Drug Administration (FDA).
  • CalciMedica plans to conduct a comprehensive review of the unblinded clinical data to inform future clinical evaluation of Auxora in AKI.
  • The company remains optimistic about Auxora's potential in acute inflammatory illnesses, expecting to finalize the design of a pivotal trial in acute pancreatitis (AP) in the first half of 2026, and is advancing CM5480 for pulmonary arterial hypertension (PAH).
Jan 28, 2026, 12:00 PM
CalciMedica Reports Q3 2025 Financial Results and Provides Clinical Updates
CALC
Earnings
Guidance Update
  • CalciMedica reported a net loss of $7.8 million, or $0.52 per basic and diluted share, for the third quarter ended September 30, 2025, compared to a net loss of $5.6 million, or $0.50 per basic and diluted share, for the same period in 2024.
  • As of September 30, 2025, the company's cash, cash equivalents, and short-term investments totaled $14.1 million, which is expected to fund operations into the second half of 2026.
  • Enrollment is ongoing in the Phase 2 KOURAGE trial of Auxora in patients with acute kidney injury (AKI) with respiratory failure, with data anticipated in the first half of 2026.
  • CalciMedica has had positive discussions with the FDA regarding the design of a pivotal trial for its acute pancreatitis (AP) program, with the final trial design expected to be finalized in the first half of 2026.
Nov 12, 2025, 12:15 PM
CalciMedica Reports Q3 2025 Financial Results and Clinical Updates
CALC
Earnings
Guidance Update
New Projects/Investments
  • CalciMedica reported a net loss of $7.8 million, or $0.52 per basic and diluted share, for the third quarter ended September 30, 2025.
  • As of September 30, 2025, cash, cash equivalents, and short-term investments were $14.1 million, which is expected to fund operations into the second half of 2026.
  • Enrollment is ongoing in the Phase 2 KOURAGE trial of Auxora in acute kidney injury (AKI) with respiratory failure, with data expected in the first half of 2026.
  • The company anticipates finalizing the design of its pivotal trial in acute pancreatitis (AP) in the first half of 2026, following positive discussions with the FDA and a collaboration with Telperian.
Nov 12, 2025, 12:01 PM
CalciMedica Announces Collaboration with Telperian for AI-Powered Clinical Trial Analysis
CALC
New Projects/Investments
  • CalciMedica Inc. announced a collaboration with Telperian to integrate Telperian's artificial intelligence (AI) engine for the analysis of clinical trial datasets from CalciMedica's lead compound, Auxora™.
  • The AI tools will be used to refine target patient populations and efficacy endpoints for CalciMedica's upcoming pivotal trials, utilizing data from completed Phase 2 trials such as CARPO (acute pancreatitis) and CARDEA (severe COVID-19 pneumonia).
  • This integration aims to provide deep, data-supported insights into Auxora's treatment benefits across patient subgroups and will support CalciMedica in its regulatory discussions with the U.S. Food and Drug Administration (FDA) for a pivotal program.
Oct 14, 2025, 11:00 AM