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Details:
Auxora (zegocractin) is a potent and selective small molecule inhibitor of Orai1-containing CRAC channels, is being evaluated in a Phase 2 trial in acute kidney injury with associated acute hypoxemic respiratory failure.
Lead Product(s): Zegocractin
Therapeutic Area: Nephrology Product Name: Auxora
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 24, 2024
Details:
Auxora (zegocractin) is a potent and selective small molecule inhibitor of Orai1-containing CRAC channels, to be evaluated in a Phase 2 trial in acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF).
Lead Product(s): Zegocractin
Therapeutic Area: Nephrology Product Name: Auxora
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2024
Details:
The net proceeds will be used for the clinical development of the Auxora (zegocractin), which is a small molecule CRAC channel inhibitor and are also planning for Phase 2 for the treatment of acute kidney injury.
Lead Product(s): Zegocractin
Therapeutic Area: Nephrology Product Name: Auxora
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Deerfield Management
Deal Size: $55.0 million Upfront Cash: $20.4 million
Deal Type: Private Placement January 22, 2024
Details:
Auxora (zegocractin) is a potent and selective small molecule inhibitor of Orai1-containing calcium release-activated calcium (CRAC) channels that is being developed for use in patients with inflammatory illnesses.
Lead Product(s): Zegocractin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Auxora
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 09, 2023
Details:
The combined company will focus on developing Auxora (zegocractin), an intravenous-formulated, small molecule CRAC channel inhibitor, to treat inflammatory diseases, such as AP, AAP which is a toxicity caused by asparaginase treatment for pediatric ALL, AKI, ALI andARDS.
Lead Product(s): Zegocractin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Auxora
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: CalciMedica
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger March 20, 2023
Details:
The proceeds will be used for the advancement of Auxora (zegocractin), an intravenous-formulated, small molecule CRAC channel inhibitor, to treat inflammatory diseases, such as AP, AAP which is a toxicity caused by asparaginase treatment for pediatric ALL, AKI, ALI andARDS.
Lead Product(s): Zegocractin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Auxora
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $10.3 million Upfront Cash: Undisclosed
Deal Type: Private Placement March 20, 2023
Details:
The combined company will focus on further developing CalciMedica’s lead product candidate Auxora, a proprietary, intravenous-formulated, small molecule calcium-release activated calcium (CRAC) channel inhibitor, to treat life-threatening inflammatory diseases.
Lead Product(s): Zegocractin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CM4620
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: CalciMedica
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger November 21, 2022
Details:
The results provide a description of underlying biological mechanisms that may explain the rapid tolerance of solid food observed in CalciMedica's Phase 2a trial of Auxora, its lead product, in patients with AP with systemic inflammatory response syndrome and hypoxemia.
Lead Product(s): Zegocractin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CM4620
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2022
Details:
CARDEA-Plus is designed to evaluate the dosing, safety, and efficacy of CM4620 (auxora), CRAC channel inhibitor in combination with both tocilizumab and corticosteroids in patients with critical COVID-19 pneumonia.
Lead Product(s): Zegocractin
Therapeutic Area: Infections and Infectious Diseases Product Name: CM4620
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 20, 2022
Details:
In the 261-patient efficacy dataset, the median time to recovery was seven days for Auxora-treated patients compared to 10 days for placebo-treated patients with a recovery ratio of 1.25.
Lead Product(s): Zegocractin
Therapeutic Area: Infections and Infectious Diseases Product Name: CM4620
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2021
Details:
Funds to support advancement of anti-inflammatory therapy, AuxoraTM, currently being evaluated in severe and critical COVID-19 pneumonia and acute pancreatitis with SIRS.
Lead Product(s): Zegocractin
Therapeutic Area: Infections and Infectious Diseases Product Name: CM4620
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Quark Venture LP
Deal Size: $21.0 million Upfront Cash: Undisclosed
Deal Type: Series D Financing March 11, 2021
Details:
Study published in Critical Care journal shows patients with severe COVID-19 pneumonia treated with Auxora and standard of care had substantially improved outcomes compared to patients on standard of care alone.
Lead Product(s): Zegocractin,Remdesivir,Dexamethasone
Therapeutic Area: Infections and Infectious Diseases Product Name: CM4620-IE
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2020
Details:
Auxora combined with standard of care therapy improved outcomes in patients with severe COVID-19 pneumonia showing faster recovery and reduced use of invasive mechanical ventilation and death as compared to standard of care alone.
Lead Product(s): Zegocractin
Therapeutic Area: Infections and Infectious Diseases Product Name: CM4620-IE
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 16, 2020
Details:
Interim results showed Auxora plus standard of care improved time to recovery and reduced ventilator use in patients compared to standard of care alone.
Lead Product(s): Zegocractin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 28, 2020
Details:
The funds from this Series C financing will go towards advancing ongoing clinical trials evaluating our CRAC channel inhibitor, Auxora (formerly CM4620-IE), in patients with COVID-19 pneumonia requiring oxygen therapy and accelerating commercial manufacturing for the drug.
Lead Product(s): Zegocractin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Valence Life Sciences
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Series C Financing May 22, 2020
Details:
The FDA has strongly recommended that CalciMedica transition from the current randomized open-label study to a blinded placebo-controlled trial as soon as possible. Recommendation follows the recent interim analysis of Auxora in severe COVID-19 pneumonia.
Lead Product(s): Zegocractin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2020
Details:
CalciMedica’s rapid receipt of notification from the FDA that it could proceed with its study is part of the agency’s initiative to expedite access to investigational drugs for the treatment COVID-19.
Lead Product(s): Zegocractin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 09, 2020
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