CalciMedica Announces Publication in the American Journal of Nephrology Discussing Design and Rationale of Phase 2 KOURAGE Trial of Auxora™ in AKI with Respiratory Failure
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 25 2025
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Should l Buy CALC?
Source: Newsfilter
CalciMedica's Research Publication: CalciMedica Inc. announced a publication in the American Journal of Nephrology detailing the Phase 2 KOURAGE trial design for their lead candidate Auxora™ in treating acute kidney injury (AKI) with respiratory failure, highlighting promising preclinical and clinical data supporting its efficacy.
KOURAGE Trial Overview: The KOURAGE trial will evaluate the safety and effectiveness of Auxora in approximately 150 patients with severe AKI and respiratory failure, focusing on days alive without the need for ventilation or dialysis, with results expected by the end of 2025.
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Analyst Views on CALC
Wall Street analysts forecast CALC stock price to rise
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Current: 0.700
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About CALC
CalciMedica, Inc. is a clinical-stage biopharmaceutical company. The Company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory and immunologic diseases. The Company's technology targets the inhibition of CRAC channels to modulate the immune response and protect against tissue cell injury. Its lead product candidate is Auxora, a potent and selective intravenous formulated small molecule CRAC channel inhibitor containing the active compound zegocractin (formerly referred to as CM4620) that, in animal models, reduced acute epithelial and/or endothelial cell injury and inflammation in organs, such as the pancreas, lungs and kidneys. The Company is conducting a Phase IIb trial (called CARPO) for acute pancreatitis (AP) with systemic inflammatory response syndrome (SIRS), as well as supporting the ongoing Phase I/II asparaginase-induced pancreatic toxicity (AIPT) study (called CRSPA).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Upgrades and Downgrades: The rating changes include upgrades and downgrades for certain stocks, prompting investors to pay attention to these shifts to assess potential investment opportunities and risks.
- Market Reaction Expectations: Analyst rating adjustments may lead to short-term volatility in the affected stocks, necessitating that investors closely monitor market dynamics to seize optimal trading opportunities.
- Source of Investment Advice: While the article does not provide specific stock names or rating details, investors can visit the analyst ratings page for a more comprehensive view of the information and recommendations available.
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CalciMedica Discontinues Trial, Stock Faces Volatility
- 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.
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CalciMedica Halts KOURAGE Clinical Trial Amid Safety Concerns
- 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.
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CalciMedica Halts Auxora Clinical Trial Due to Safety Concerns
- 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.
See More
Wall Street Analysts Adjust Ratings
- Analyst Rating Changes: Top Wall Street analysts have adjusted their ratings on several companies, reflecting varying market perspectives that could influence investor decisions and market trends.
- Upgrades and Downgrades: The rating changes include upgrades and downgrades for certain stocks, prompting investors to pay attention to these shifts to assess potential investment opportunities and risks.
- Market Reaction Expectations: Analyst rating adjustments may lead to short-term volatility in the affected stocks, necessitating that investors closely monitor market dynamics to seize optimal trading opportunities.
- Source of Investment Advice: While the article does not provide specific stock names or rating details, investors can visit the analyst ratings page for a more comprehensive view of the information and recommendations available.
See More
CalciMedica Discontinues Trial, Stock Faces Volatility
- 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.
See More
CalciMedica Halts KOURAGE Clinical Trial Amid Safety Concerns
- 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.
See More
U.S. Stocks Mixed as Energy Shares Rise Amid Crude Inventory Decline
- 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.
See More
U.S. Stocks Mostly Higher; Starbucks Beats Q1 Sales Expectations
- 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.
See More
CalciMedica Halts Auxora Clinical Trial Due to Safety Concerns
- 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.
See More
