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CalciMedica, Inc. - CALC STOCK NEWS

Welcome to our dedicated page for CalciMedica news (Ticker: CALC), a resource for investors and traders seeking the latest updates and insights on CalciMedica stock.

CalciMedica, Inc. (Nasdaq: CALC) is a clinical-stage biopharmaceutical company dedicated to discovering and developing novel small molecule drugs for treating autoimmune disorders, organ transplant rejection, and other immune diseases. The company's primary focus is on developing therapies for life-threatening inflammatory diseases with a high unmet need. Utilizing its proprietary technology, CalciMedica targets the inhibition of calcium release-activated calcium (CRAC) channels. This approach is designed to modulate the immune response and protect against tissue cell injury, offering therapeutic benefits for diseases with no approved therapies.

CalciMedica's lead product candidate, Auxora™, is an intravenous-formulated CRAC channel inhibitor that has shown promising results in multiple clinical trials. The company is currently conducting several significant studies:

  • CARPO Trial: A Phase 2b international, randomized, double-blind, placebo-controlled, dose-ranging trial aimed at establishing Auxora's efficacy in treating acute pancreatitis with accompanying systemic inflammatory response syndrome (SIRS). The trial has successfully enrolled 216 patients, with topline data expected in the second quarter of 2024.
  • CRSPA Study: An investigator-sponsored Phase 1/2 trial focusing on pediatric patients with acute lymphoblastic leukemia (ALL) experiencing asparaginase-induced pancreatic toxicity (AIPT). This study aims to define an optimal pediatric dose for Auxora and is expected to provide additional data by the second half of 2024.
  • KOURAGE Trial: A Phase 2 trial targeting patients with acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF). This randomized, double-blind, placebo-controlled study plans to evaluate 150 patients, with data anticipated in 2025.

CalciMedica has also secured substantial funding through a securities purchase agreement, raising up to $55 million in gross proceeds. This financing will support ongoing and planned clinical trials, bringing the company closer to achieving its goal of providing effective treatments for critically ill patients.

Recent achievements include the presentation of positive Phase 1/2 CRSPA study results at the 65th Annual American Society of Hematology Meeting and the clearance of an Investigational New Drug (IND) application by the FDA for the KOURAGE trial. Additionally, the company has engaged in a private placement financing, ensuring continued financial health and the ability to pursue pivotal clinical trials.

Founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, CalciMedica is headquartered in La Jolla, CA. For more information, visit www.calcimedica.com.

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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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CalciMedica Inc. announced the presentation of data from the CRSPA study of Auxora™ in asparaginase-induced pancreatic toxicity (AIPT) at the ASH Meeting. The results showed a 53% reduction in hospital days, a 40% reduction in ICU days, and eliminated the need for total parenteral nutrition (TPN).
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CalciMedica to participate in H.C. Wainwright conference and host virtual Acute Pancreatitis event.
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CalciMedica to host virtual clinical experts event on September 21, 2023, discussing lead clinical compound Auxora™ and its potential implications in acute pancreatitis.
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FAQ

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

The current stock price of CalciMedica (CALC) is $2.76 as of December 20, 2024.

What is the market cap of CalciMedica (CALC)?

The market cap of CalciMedica (CALC) is approximately 38.6M.

What is CalciMedica, Inc. focused on?

CalciMedica is focused on discovering and developing novel small molecule drugs for the treatment of autoimmune disorders, organ transplant rejection, and other immune diseases.

What is Auxora™?

Auxora™ is CalciMedica's lead product candidate, a potent and selective CRAC channel inhibitor being developed for use in patients with acute inflammatory and immunologic illnesses.

What is the CARPO trial?

The CARPO trial is a Phase 2b study aimed at establishing Auxora's efficacy in treating acute pancreatitis with systemic inflammatory response syndrome (SIRS).

What are CRAC channels?

CRAC channels are calcium release-activated calcium channels targeted by CalciMedica's proprietary technology to modulate the immune response and protect against tissue cell injury.

What are the latest updates from CalciMedica?

Recent updates include positive results from the Phase 1/2 CRSPA study, FDA clearance for the KOURAGE trial, and successful enrollment in the CARPO trial.

How is CalciMedica funded?

CalciMedica recently raised up to $55 million in gross proceeds through a securities purchase agreement, supporting ongoing and planned clinical trials.

Where is CalciMedica headquartered?

CalciMedica is headquartered in La Jolla, CA.

Are there any approved therapies for the diseases CalciMedica targets?

Currently, there are no approved therapies for many of the life-threatening inflammatory and immunologic diseases that CalciMedica targets with its CRAC channel inhibitors.

What is the KOURAGE trial?

The KOURAGE trial is a Phase 2 study evaluating Auxora in patients with acute kidney injury associated with acute hypoxemic respiratory failure. Data is expected in 2025.

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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38.56M
10.55M
17.48%
43.87%
0.68%
Biotechnology
Pharmaceutical Preparations
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United States of America
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