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CALCIMEDICA INC - CALC STOCK NEWS

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About CalciMedica Inc.

CalciMedica Inc. (Nasdaq: CALC) is a clinical-stage biopharmaceutical company dedicated to advancing the treatment of acute and chronic inflammatory and immunologic diseases through its innovative calcium release-activated calcium (CRAC) channel inhibition technology. Headquartered in La Jolla, California, the company is pioneering therapies that target CRAC channels to modulate immune responses and protect against tissue injury, addressing critical unmet medical needs in life-threatening conditions.

Core Technology and Therapeutic Focus

CalciMedica's proprietary technology revolves around the inhibition of CRAC channels, which are integral to immune cell activation and inflammatory responses. By targeting these channels, the company aims to reduce inflammation, prevent organ damage, and improve clinical outcomes in patients with acute and chronic inflammatory syndromes. The company's lead product candidate, Auxora™, is a potent and selective small molecule inhibitor of Orai1-containing CRAC channels. This intravenous formulation has demonstrated promising results in preclinical and clinical trials, showcasing its potential to treat severe inflammatory diseases.

Lead Product Candidate: Auxora™

Auxora™ is being developed to address multiple acute inflammatory conditions, including:

  • Acute Pancreatitis (AP): A life-threatening condition characterized by systemic inflammation and organ failure. Auxora™ has shown efficacy in reducing severe organ failure and hospital length of stay in patients with AP and accompanying systemic inflammatory response syndrome (SIRS).
  • Acute Kidney Injury (AKI): A critical illness involving sudden kidney function loss, often associated with high mortality rates. Auxora™ is currently being evaluated in the Phase 2 KOURAGE trial for AKI with acute hypoxemic respiratory failure (AHRF).
  • Pediatric Pancreatic Toxicity (AIPT): A severe side effect of leukemia treatment in children, for which Auxora™ is being investigated in the ongoing CRSPA trial.

With no approved therapies available for these conditions, Auxora™ represents a significant advancement in addressing these unmet medical needs.

Clinical Development Pipeline

CalciMedica's robust pipeline includes multiple clinical trials:

  • CARPO Trial: A Phase 2b trial evaluating Auxora™ for acute pancreatitis with SIRS, which demonstrated positive topline results, including reduced organ failure and improved recovery times.
  • KOURAGE Trial: A Phase 2 study targeting severe AKI with AHRF, focusing on ventilator-free and dialysis-free survival as key endpoints.
  • CRSPA Trial: An investigator-sponsored Phase 1/2 trial exploring Auxora™ for pediatric patients with asparaginase-induced pancreatic toxicity.

These trials highlight CalciMedica's commitment to advancing therapies for critical illnesses with no current treatment options.

Market Position and Industry Significance

CalciMedica operates at the forefront of immunology and inflammation research, leveraging its expertise in CRAC channel biology to address high-burden diseases. The company’s focus on severe, life-threatening conditions positions it as a key innovator in the biopharmaceutical space. By targeting diseases with no approved therapies, CalciMedica addresses significant gaps in patient care and healthcare systems.

Strategic Vision

Founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, CalciMedica combines cutting-edge science with clinical expertise to develop transformative therapies. The company’s strategic vision includes advancing Auxora™ through pivotal trials, expanding its therapeutic indications, and collaborating with regulatory authorities to bring life-saving treatments to market.

Conclusion

CalciMedica Inc. exemplifies innovation and dedication in the biopharmaceutical industry. With its proprietary CRAC channel inhibition technology, the company is poised to address critical unmet needs in inflammatory and immunologic diseases, offering hope to patients and advancing the field of acute care medicine.

Rhea-AI Summary

CalciMedica Inc. announces an upcoming presentation at Digestive Disease Week 2024 where collaborators from Cedars-Sinai will present human proteomics data supporting the potential benefits of Auxora™ in severe acute pancreatitis. The presentation will highlight the similarities between the benefits of Auxora and those seen in COVID-19 pneumonia.

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CalciMedica Inc. announces the successful enrollment of the last patient in its Phase 2b CARPO trial of Auxora™ for acute pancreatitis. The trial reached its target enrollment of 216 patients, with topline data expected in 2Q 2024. Auxora is a small molecule inhibitor of CRAC channels developed for inflammatory and immunologic illnesses. The CEO expressed gratitude towards patients and families for their trust in the trial.
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CalciMedica Inc. reported financial results for 2023, highlighting progress in clinical trials for Auxora™ in acute pancreatitis and severe acute kidney injury. Recent achievements include IND clearance for AKI trial, expansion of AIPT study, and successful private placement financing. The company's cash position is strong, with plans to fund operations into 2025.
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CalciMedica Inc. presented data from preclinical studies of Auxora in acute kidney injury (AKI) at the 29th International Acute Kidney Injury and Continuous Renal Replacement Therapy Conference. The results showed that Auxora improved kidney function and survival in rat models of AKI, supporting the upcoming KOURAGE trial in severe AKI patients.
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CalciMedica Inc. announces positive preclinical data for Auxora in treating acute kidney injury (AKI) in rats, showing improved kidney function. The study indicates that Auxora can enhance glomerular filtration rate, suggesting potential therapeutic benefits for AKI.
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CalciMedica, Inc. announces the clearance of its IND application by the FDA for its lead product candidate, Auxora, to be evaluated in a Phase 2 trial for acute kidney injury with associated acute hypoxemic respiratory failure. The trial, named KOURAGE, aims to address the high mortality rate of patients suffering from severe AKI, a condition with no approved therapies. The study will evaluate 150 patients with stage 2 and 3 AKI and AHRF, with primary endpoints focusing on days alive, ventilator-free, and dialysis-free through day 30. The development of Auxora is supported by clinical and pre-clinical evidence, showing promising results in animal models of AKI and COVID-19 pneumonia patients.
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CalciMedica Inc. announced the participation of CEO Rachel Leheny in the Oppenheimer 34th Annual Healthcare Life Sciences Conference. The company is focused on developing CRAC channel inhibition therapies for inflammatory and immunologic illnesses. The presentation will be available via live webcast and archived for 90 days on the company's website.
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CalciMedica, Inc. announced a securities purchase agreement to raise up to $55 million in gross proceeds, with an upfront funding of $20.4 million and potential additional funding of $34.2 million. The financing will support the expansion of Auxora™ clinical development, including planned Phase 2 acute kidney injury (AKI) trial, and fund subsequent clinical trials in acute pancreatitis (AP) and AKI programs. New and existing investors, including healthcare-dedicated investors, are participating in the financing.
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CalciMedica Inc. (CALC) announced positive results from the Phase 1/2 CRSPA study of Auxora™ in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT) at the 65th Annual American Society of Hematology (ASH) Meeting & Exposition. Auxora treatment potentially reduces the severity of AIPT, eliminating the need for total parenteral nutrition, and resulting in reduced hospital and intensive care unit days. The study showed a 53% reduction in days in hospital and a 40% reduction in intensive care unit days compared to a historical matched control group. None of the Auxora-treated patients had significant necrosis compared to 27% of historical control patients at 30 days.
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CalciMedica Inc. (CALC) reported financial results and clinical updates for the third quarter, highlighting the expansion of Phase 1/2 CRSPA study of Auxora™ in asparaginase-induced pancreatic toxicity (AIPT) and the international expansion of Phase 2b CARPO trial in acute pancreatitis (AP) patients with accompanying systemic inflammatory response syndrome (SIRS). The company anticipates topline data from the CARPO trial in the first half of 2024 and is preparing to file an IND application for Auxora™ in acute kidney injury (AKI).
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FAQ

What is the current stock price of CALCIMEDICA (CALC)?

The current stock price of CALCIMEDICA (CALC) is $2.2 as of March 3, 2025.

What is the market cap of CALCIMEDICA (CALC)?

The market cap of CALCIMEDICA (CALC) is approximately 29.9M.

What does CalciMedica Inc. specialize in?

CalciMedica specializes in developing CRAC channel inhibition therapies for acute and chronic inflammatory and immunologic diseases.

What is Auxora™?

Auxora™ is CalciMedica's lead product candidate, a selective CRAC channel inhibitor being developed for conditions like acute pancreatitis, acute kidney injury, and pediatric pancreatic toxicity.

What is the significance of CRAC channel inhibition?

CRAC channel inhibition modulates immune responses and protects against tissue injury, offering therapeutic benefits in severe inflammatory diseases.

What clinical trials is CalciMedica conducting?

CalciMedica is conducting trials such as the CARPO trial for acute pancreatitis, the KOURAGE trial for acute kidney injury, and the CRSPA trial for pediatric pancreatic toxicity.

What makes CalciMedica unique in the biopharmaceutical industry?

CalciMedica's focus on CRAC channel biology and its dedication to addressing diseases with no approved therapies set it apart as an innovator in acute care medicine.

Where is CalciMedica headquartered?

CalciMedica is headquartered in La Jolla, California.

What are the key therapeutic areas for CalciMedica?

CalciMedica targets acute pancreatitis, acute kidney injury, and pediatric pancreatic toxicity, among other inflammatory and immunologic diseases.

What is the KOURAGE trial?

The KOURAGE trial is a Phase 2 study evaluating Auxora™ for severe acute kidney injury with associated acute hypoxemic respiratory failure.

How does CalciMedica contribute to addressing unmet medical needs?

CalciMedica develops therapies for life-threatening diseases with no approved treatments, such as acute pancreatitis and acute kidney injury.

Who founded CalciMedica?

CalciMedica was founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research.
CALCIMEDICA INC

Nasdaq:CALC

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29.93M
11.10M
17.48%
43.87%
0.68%
Biotechnology
Pharmaceutical Preparations
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United States
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