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.
Overview
CalciMedica Inc (CALC) is a clinical‐stage biopharmaceutical company dedicated to the discovery and development of novel small molecule therapies that target calcium release-activated calcium (CRAC) channels. By focusing on CRAC channel inhibition, the company aims to modulate the immune response and protect against tissue injury in life-threatening inflammatory and immunologic diseases. Core therapeutic areas include autoimmune disorders, organ transplant rejection, acute pancreatitis with systemic inflammatory response syndrome (SIRS), acute kidney injury (AKI) with associated respiratory failure, and pediatric conditions linked to asparaginase-induced pancreatic toxicity.
Innovative Technology and Therapeutic Focus
At the heart of CalciMedica’s approach is its proprietary technology targeting CRAC channels. These channels play a critical role in cellular calcium influx and immune cell activation, which are central to the pathogenesis of numerous inflammatory and immunologic diseases. By selectively inhibiting CRAC channels, CalciMedica’s lead product candidate, Auxora™, is designed to attenuate overactive immune responses while simultaneously offering organ tissue protection. This dual mechanism of action underlines the potential of their therapies to treat conditions with high unmet medical need for which no approved therapies exist.
Clinical Programs and Pipeline
CalciMedica’s pipeline is robust, encompassing multiple clinical trials addressing severe acute illnesses:
- Acute Pancreatitis (AP) with SIRS: The Phase 2b CARPO trial evaluates the efficacy of Auxora in improving clinical outcomes in AP patients. The trial is international, randomized, and placebo-controlled, ensuring rigorous assessment of dose-response and safety.
- Acute Kidney Injury (AKI) with Respiratory Failure: The Phase 2 KOURAGE trial examines Auxora in patients with Stage 2 and Stage 3 AKI accompanied by acute hypoxemic respiratory failure. Enrollment criteria are designed to select patients experiencing severe inflammation, addressing a critical area with no current approved therapy.
- Pediatric Asparaginase-Induced Pancreatic Toxicity (AIPT): An investigator-sponsored Phase 1/2 trial investigates Auxora’s potential in pediatric patients undergoing treatment for acute lymphoblastic leukemia, where asparaginase therapy can lead to debilitating pancreatic toxicity.
Market Position and Competitive Landscape
Within the dynamic biopharmaceutical landscape, CalciMedica differentiates itself through its focused approach on CRAC channel inhibition—a mechanism that directly addresses underlying inflammatory pathways rather than merely treating symptoms. The company has garnered attention from leading life science investors and secured strategic financing arrangements, highlighting confidence in its science and clinical promise. Its rigorous clinical trials and adherence to robust regulatory standards position it as a notable player in treating diseases with significant unmet needs.
Expertise, Safety, and Future Readiness
CalciMedica’s commitment to advancing therapies through well-designed clinical trials reinforces its expertise and credibility. Clinical data have consistently demonstrated a well-tolerated safety profile for Auxora™, with meaningful improvements in critical endpoints such as time to solid food tolerance in AP and reduction in severe organ failure in trial participants. Detailed and transparent reporting reinforces the company’s authoritativeness in its field while ensuring that the scientific community and investors receive balanced, factual information regarding its progress. The company’s strategy underlines its focus on solving complex inflammatory conditions through targeted and innovative approaches, reflecting deep industry insights and technical precision.
Summary
In summary, CalciMedica Inc is firmly positioned at the intersection of cutting-edge science and clinical need. Through its unique CRAC channel inhibition strategy, the company is addressing severe inflammatory and immunologic diseases with no current approved therapeutic options. With a clearly articulated clinical pipeline, robust scientific rationale, and considerable industry expertise, CalciMedica provides a comprehensive model of innovation and excellence in biopharmaceutical research and development.
CalciMedica (Nasdaq: CALC), a clinical-stage biopharmaceutical company, announced the appointment of Stephen Bardin as Chief Financial Officer, succeeding Daniel Geffken, Interim CFO, upon the filing of the third quarter financial statements. Bardin, who previously served as CFO of atai Life Sciences, brings extensive expertise in capital raising, corporate development, and strategic finance. He has already contributed to CalciMedica's successful public financing and will play a key role in advancing their clinical-stage pipeline, including the CARPO Phase 2b trial in acute pancreatitis and the upcoming KOURAGE Phase 2 trial in acute kidney injury. Bardin's background includes significant roles at BridgeBio Pharma and Myovant Sciences, and he holds an M.B.A. from Stanford and a B.S.E. from Duke University.
CalciMedica (Nasdaq: CALC) has announced the pricing of an underwritten public offering of 2,720,000 shares of common stock at $3.75 per share. The company expects to raise gross proceeds of $10,200,000 before deducting underwriting costs and expenses. CalciMedica has granted underwriters a 30-day option to purchase up to an additional 408,000 shares at the public offering price. The offering is expected to close around November 1, 2024. Jones is serving as the sole book-running manager for this offering, which is being conducted under a shelf registration statement previously declared effective by the SEC.
CalciMedica (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing CRAC channel inhibition therapies, has announced a proposed underwritten public offering of common stock. The company plans to grant underwriters a 30-day option to purchase up to an additional 15% of the offered shares. Jones will serve as the sole book-running manager. The offering is being made through a shelf registration statement on Form S-3 previously filed with the SEC. The completion, size, and terms of the offering are subject to market conditions.
CalciMedica (CALC) announced positive Phase 2b CARPO trial results for Auxora™ in acute pancreatitis (AP) patients with SIRS. The trial showed a 100% reduction in new-onset severe respiratory failure (p=0.0027) and 64.2% reduction in persistent respiratory failure (p=0.0476) for combined high/medium doses versus low dose/placebo. The high dose (2.0 mg/kg) demonstrated a significant stratified win ratio of 1.640 (p=0.0372) compared to placebo. Additional benefits included reduced necrotizing pancreatitis and shorter hospital stays. The drug was well-tolerated with no drug-related serious adverse events in the high-dose group.
CalciMedica (Nasdaq: CALC) announced a conference call and webcast scheduled for Wednesday, October 30, 2024, at 12 p.m. ET to present the complete data set and win ratio analysis from their Phase 2b CARPO trial of Auxora™ in acute pancreatitis (AP) with systemic inflammatory response syndrome (SIRS). Prof. Robert Sutton from the University of Liverpool, chair of the CARPO trial Steering Committee, will deliver a plenary presentation titled 'A Randomized, Double-Blind, Placebo Controlled Dose Ranging Study of Auxora in Patients with AP and Accompanying SIRS - CARPO' from the American College of Gastroenterology 2024 Annual Scientific Meeting.
CalciMedica Inc. (Nasdaq: CALC) announced the acceptance of a late-breaking abstract for a plenary presentation at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. The presentation will be given by Prof. Robert Sutton from the University of Liverpool and Liverpool University Hospitals NHS Foundation Trust on October 30, 2024 at 10:00-10:15 a.m. ET in the Grand Ballroom.
Prof. Sutton is the chair of the Steering Committee for the CARPO acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS) clinical trial. The presentation is part of the Simultaneous Plenary Session 4A and is listed as Abstract #64. The abstract authors include researchers from various institutions, including CalciMedica, Inc.
CalciMedica Inc. (Nasdaq: CALC), a clinical-stage biopharmaceutical company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company's CEO, Rachel Leheny, Ph.D., will deliver a presentation on September 9, 2024, at 7:00 a.m. ET/ 4:00 a.m. PT.
CalciMedica specializes in developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses. Investors and interested parties can access a live webcast of the presentation through the company's IR website. The webcast replay will be available for 90 days following the event.
CalciMedica Inc. (Nasdaq: CALC) reported its Q2 2024 financial results and provided clinical updates. Key highlights include:
1. Positive topline data from the Phase 2b CARPO trial of Auxora™ in acute pancreatitis (AP).
2. First patient enrolled in the Phase 2 KOURAGE trial of Auxora™ in severe acute kidney injury (AKI).
3. Inclusion in the Russell Microcap® Index.
4. Expansion of the CRSPA study in asparaginase-induced pancreatic toxicity (AIPT).
Financial results: $19.1 million in cash and equivalents as of June 30, 2024. Q2 2024 net loss of $4.0 million ($0.36 per share). H1 2024 net loss of $3.8 million ($0.37 per share).
CalciMedica has announced the first patient enrollment in its Phase 2 KOURAGE trial, testing Auxora™ for severe acute kidney injury (AKI) with acute hypoxemic respiratory failure (AHRF). This trial, supported by clinical and pre-clinical evidence, aims to enroll 150 patients. Participants will receive daily doses of Auxora or placebo and will be evaluated up to 30 days post-dosing. The study includes secondary endpoints like all-cause mortality and kidney function decline over 90 days. Previous trials and preclinical models have shown promising results for Auxora. Topline data are expected in 2025.
With AKI causing 3.7 million hospitalizations annually in the U.S., this trial could pave the way for a novel treatment in a field currently to supportive care.
CalciMedica, a clinical-stage biopharmaceutical company specializing in CRAC channel inhibition therapies, announced that CEO Rachel Leheny, Ph.D., will present at two upcoming healthcare investment conferences on July 15, 2024. The events include the H.C. Wainwright 3rd Annual Kidney Virtual Conference at 11:00 AM ET/8:00 AM PT and the JonesTrading Healthcare Seaside Summit at 1:15 PM ET/10:15 AM PT. Live webcasts of these presentations will be available on CalciMedica's Investor Relations website and will be archived for 90 days.
FAQ
What is the current stock price of CALCIMEDICA (CALC)?
What is the market cap of CALCIMEDICA (CALC)?
What is the primary focus of CalciMedica Inc?
Which therapeutic areas are targeted by CalciMedica's pipeline?
How does CalciMedica's technology work?
What distinguishes Auxora™ from other drug candidates?
Why is CRAC channel inhibition important in treating inflammatory diseases?
What type of clinical trials is CalciMedica conducting?
How is CalciMedica positioned within its competitive landscape?
