CalciMedica Reports Third Quarter 2025 Financial Results and Provides Clinical & Corporate Updates
KOURAGE Trial Update: CalciMedica is currently enrolling patients in the Phase 2 KOURAGE trial for Auxora™ targeting acute kidney injury (AKI) with respiratory failure, with data expected in the first half of 2026.
FDA Discussions on Acute Pancreatitis: The company has had positive discussions with the FDA regarding the design of a pivotal trial for acute pancreatitis, which is anticipated to be finalized in the first half of 2026.
Financial Position: As of September 30, 2025, CalciMedica reported a cash position of $14.1 million, expected to fund operations into the second half of 2026, despite a net loss of $7.8 million for the third quarter.
Collaboration with Telperian: CalciMedica announced a collaboration with Telperian to utilize AI-driven analytics for optimizing the design of its pivotal trial in acute pancreatitis, leveraging insights from previous Auxora trials.
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- Trial Discontinuation: CalciMedica announced the discontinuation of its Auxora trial for acute kidney injury patients due to safety concerns raised by an independent data monitoring committee, resulting in a 76% drop in stock price at Wednesday's close, followed by an additional 4% decline in after-hours trading.
- Safety Reevaluation: Although no deaths or serious adverse events related to the study drug occurred, the committee's recommendation to reevaluate the study design, particularly patient enrollment criteria, could significantly impact the future clinical testing strategy for Auxora.
- Analyst Perspective: Oppenheimer views CalciMedica's stock as significantly undervalued following the announcement, asserting that even without revenue potential from AKI, the $200 million opportunity in acute pancreatitis supports a favorable outlook, maintaining an 'Outperform' rating.
- Market Sentiment Shift: On Stocktwits, retail sentiment around CALC stock surged from 'bearish' to 'extremely bullish' within 24 hours, with message volume increasing from 'low' to 'extremely high', indicating strong investor hopes for a price rebound.
- Trial Discontinuation: CalciMedica announced the halt of its Phase 2 KOURAGE clinical trial evaluating Auxora for acute kidney injury due to recommendations from the Independent Data Monitoring Committee, leading to a significant drop in stock price.
- Safety Concerns: While no deaths or serious adverse events occurred during the trial, safety issues identified by the IDMC necessitated a reevaluation of the study design, particularly regarding patient enrollment criteria, impacting future clinical evaluations.
- Weak Stock Performance: CalciMedica shares are currently trading at $0.99, 83.5% below the 20-day simple moving average, with a 65.68% decline over the past year, reflecting ongoing challenges for the company.
- Future Outlook: Despite the trial's discontinuation, CalciMedica remains optimistic about Auxora's potential in treating acute inflammatory illnesses and plans to finalize the pivotal trial design for acute pancreatitis in the first half of 2026, indicating strategic foresight.
- Mixed Market Performance: U.S. stocks showed mixed results on Wednesday, with the S&P 500 falling approximately 0.1%, while the Dow Jones rose 0.02% to 49,012.75 points, indicating market uncertainty.
- Energy Sector Gains: Energy shares increased by 0.7% during Wednesday's trading, reflecting optimistic expectations for energy demand despite the overall market's poor performance.
- Crude Inventory Decline: U.S. crude stocks fell by 2.296 million barrels for the week ending January 23, significantly lower than the market's expected increase of 1.75 million barrels, suggesting supply constraints that could drive oil prices higher.
- Mortgage Applications Drop: The volume of mortgage applications decreased by 8.5% in the week ending January 23, indicating a weakening demand for home purchases that may impact the recovery of the real estate market.
- Market Performance: U.S. stocks traded mostly higher on Wednesday, with the Nasdaq Composite gaining around 150 points and the S&P 500 rising 0.31% to 6,999.99, indicating positive market sentiment and increased investor confidence.
- Starbucks Earnings: Starbucks Corporation (NASDAQ:SBUX) shares rose about 5% on Wednesday, despite adjusted earnings of 56 cents per share missing market expectations of 59 cents, as sales of $9.915 billion exceeded expectations of $9.630 billion, showcasing strong sales growth.
- Sector Dynamics: Consumer discretionary stocks gained 0.9%, while healthcare stocks fell by 0.7%, reflecting a divergence in investor sentiment across different sectors, which may influence future investment strategies.
- Commodity Markets: Oil prices rose 1.3% to $63.19, gold increased by 3.7% to $5,272.90, and silver surged 8.4% to $114.830, indicating active commodity markets and heightened demand for safe-haven assets.
- Trial Suspension: CalciMedica has announced the suspension of its Phase 2 KOURAGE clinical trial for Auxora™ in acute kidney injury patients due to safety concerns raised by the Independent Data Monitoring Committee, which may impact future clinical evaluations.
- Data Analysis Plan: The company plans to conduct a comprehensive review of unblinded clinical data to assess the impact of baseline characteristics, disease severity, and other factors on patient outcomes, guiding future clinical testing of Auxora in AKI.
- Safety Assessment Results: No deaths related to Auxora or placebo were reported in the trial, and no serious adverse events met the criteria for expedited reporting to the FDA, indicating good safety for Auxora in over 350 critically ill patients.
- Future Trial Outlook: CalciMedica aims to finalize the pivotal trial design for Auxora in acute pancreatitis in the first half of 2026, pending FDA feedback, while also advancing CM5480 as a potential treatment for pulmonary arterial hypertension.











