Zegocractin

Internal and external reviews of all available safety data from the Phase 2 KOURAGE trial in acute kidney injury (AKI) did not identify evidence of a drug-related toxicity with Auxora™ Design of pivotal program in acute pancreatitis (AP) expected in 1H 2026 JCI Insight publication of preclinical data demonstrates CM5480 as a potential differentiated therapy in pulmonary arterial hypertension (PAH); IND submission anticipated in 2027 LA JOLLA, Calif., March 3, 2026 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today reported financial results for the year ended December 31, 2025 and provided clinical and corporate updates. "First and foremost, in acute kidney injury, we and our external advisors have reviewed the unblinded KOURAGE data and have found no evidence of a drug-related toxicity. We look forward to discussions with the FDA about potential future clinical studies in AKI. We are also advancing Auxora towards the pivotal program in acute pancreatitis following constructive FDA engagement and the peer-reviewed publication of our Phase 2b CARPO results. The Company plans to finalize the design for this program in the first half of this year," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "Concurrently, we continue to advance our second CRAC channel inhibitor, CM5480, in pulmonary arterial hypertension, following the recent publication of preclinical data which demonstrate its potential in cardiopulmonary disease." Recent Program Highlights: Acute Kidney Injury (AKI) with Acute Hypoxemic Respiratory Failure (AHRF) Program Update Phase 2 KOURAGE trial safety review: In January 2026, CalciMedica announced the discontinuation of the Phase 2 KOURAGE trial evaluating Auxora in patients with Stage 2 or Stage 3 AKI with associated AHRF. The decision followed a recommendation from the trial's Independent Data Monitoring Committee (IDMC) regarding a safety concern relating to a mortality imbalance that warranted reevaluation of the study design. The IDMC did not identify evidence of drug-related toxicity, and the Company's comprehensive review, performed in conjunction with external experts, reached the same conclusion. Imbalances in the patients' severity of disease at baseline may have contributed to the observed safety concern. Next steps in AKI: The Company plans to discuss the KOURAGE data and potential future development in AKI with the FDA in the second quarter of 2026. The trial remains ongoing for patient follow-up. Acute Pancreatitis (AP) Program Update Positive FDA engagement on pivotal program in AP: CalciMedica continues constructive discussions with the U.S. Food and Drug Administration (FDA) regarding the pivotal program for Auxora in AP and expects to finalize the program design in the first half of 2026. This would represent the first U.S. pivotal program evaluating a therapeutic candidate for AP, an illness with approximately 300K hospitalizations annually in the U.S. Phase 2b CARPO trial results published in eClinicalMedicine: In February 2026, a manuscript authored by CalciMedica and collaborators titled "Zegocractin for acute pancreatitis with systemic inflammatory response syndrome: a randomized, controlled, dose-ranging, phase 2b trial" was published in eClinicalMedicine, a journal in The Lancet Discovery Science suite. The publication details previously announced topline results from 214 patients enrolled in the Phase 2b CARPO trial of Auxora in AP with systemic inflammatory response syndrome (SIRS). In hyper-inflamed patients, Auxora demonstrated clinically meaningful, dose-dependent reductions in median time to solid food tolerance. Across the overall study population, Auxora demonstrated dose-dependent improvements in multiple clinically relevant endpoints, including reductions in organ failure, necrotizing pancreatitis, and time to medically indicated discharge. Notably, medium- and high-dose Auxora arms achieved a statistically significant 100% reduction in new-onset severe respiratory failure compared to placebo (p < 0.05), and the high-dose Auxora arm achieved a statistically significant stratified win ratio of 1.640 (p < 0.05), which represents a hierarchical composite of mortality, new-onset severe respiratory failure, new-onset necrotizing pancreatitis, and time to medically indicated discharge. Auxora was generally well tolerated, with a trend of decreasing treatment-emergent serious adverse event (TESAE) rates with increasing doses of drug. Additionally, there were no drug-related TESAEs or deaths in patients receiving the high dose of Auxora. Pulmonary Arterial Hypertension (PAH) Program Update Publication in JCI Insight highlighting CM5480 in a pulmonary arterial hypertension (PAH) model: In November 2025, a manuscript authored by CalciMedica and collaborators titled "Combination of Orai1 Inhibitor CM5480 with Specific Therapy Mitigates Pulmonary Hypertension and Its Cardiac Dysfunction" was published in JCI Insight. The publication describes preclinical data supporting CalciMedica's proprietary CRAC channel inhibitor candidate, CM5480, as a potential first-in-class, differentiated therapy for the treatment of PAH. In an animal model of PAH, CM5480 restored or improved multiple disease-affected pathways and functions—including heart contraction and cardiac output, gene expression profiles, DNA repair, and metabolism. Treatment with CM5480 also significantly reduced right ventricular dysfunction (RVD) both as a monotherapy and in combination with existing PAH therapies. Preclinical activities to advance CM5480 in PAH underway: Ongoing studies are being conducted to further characterize CM5480's pharmacology, pharmacokinetics, and safety profile to support IND (investigational new drug)-enabling development in PAH. An IND submission is currently anticipated in 2027. Financial Results for the Year Ended December 31, 2025: Cash Position: Cash, cash equivalents, and short-term investments were $13.0 million as of December 31, 2025. The Company expects its cash position to be sufficient to fund its current operating plan into the fourth quarter of 2026. R&D Expenses: Research and development expenses were $15.2 million for the year ended December 31, 2025, compared to $14.5 million for the year ended December 31, 2024. The increase of $0.7 million was primarily due to an increase in preclinical and clinical trial related activities offset by a decrease in chemistry, manufacturing, and control activities and personnel costs. G&A Expenses: General and administrative expenses were $7.9 million for the year ended December 31, 2025, compared to $9.7 million for the year ended December 31, 2024. The decrease of $1.8 million was primarily due to a decrease in consultants and other costs and professional services offset by an increase in personnel costs driven by stock-based compensation. Other Income (Expense): Other expenses were $6.4 million for the year ended December 31, 2025, compared to other income of $10.5 million for the year ended December 31, 2024. The increase of $16.9 million of expense was primarily due to the non-cash fair value adjustments to the Company's financial instruments, an increase in interest expense associated with the Company's promissory note, and a decrease in interest income offset by miscellaneous income. Net Loss: Net loss was $29.6 million, or $1.97 per basic and diluted share, for the year ended December 31, 2025, compared to $13.7 million, or $1.22 per basic and diluted share, for the year ended December 31, 2024. About CalciMedica CalciMedica is a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory and immunologic diseases. CalciMedica's proprietary technology targets the inhibition of CRAC channels to modulate the immune response and protect against tissue cell injury, with the potential to provide therapeutic benefits in serious and life-threatening conditions with high unmet need. CalciMedica's lead product candidate Auxora™ has demonstrated positive clinical results in multiple completed efficacy clinical trials. The Company has reported data from a Phase 2b trial (CARPO; NCT04681066) evaluating Auxora in patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS), as well as from a Phase 2 trial (CARDEA; NCT04345614) in patients with severe COVID-19 pneumonia. The Company initiated a Phase 2 trial (KOURAGE; NCT06374797) evaluating Auxora in patients with acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF); in January 2026, the trial was discontinued following a recommendation from the Independent Data Monitoring Committee, and the Company plans to discuss potential future development in AKI with the FDA. In addition, CalciMedica is advancing CM5480 as a potential therapy for pulmonary arterial hypertension (PAH), supported by preclinical data demonstrating effects on pulmonary vascular remodeling and right ventricular function. For more information, please visit . Forward-Looking Statements This communication contains forward-looking statements which include, but are not limited to, CalciMedica's expected cash runway; CalciMedica's planned and ongoing clinical trials and the timing, design, and the expected timing for updates; statements regarding the anticipated timing of filing an IND; statements regarding the safety and efficacy of its product candidates; statements regarding FDA's positive engagement on a pivotal program for Auxora in AP and a final pivotal program design in the first half of 2026; statements regarding the analysis of the unblinded KOURAGE dataset, including timing of discussions with the FDA and whether such analysis will inform future trial parameters; and the potential of CalciMedica's proprietary technology to provide therapeutic benefits in PAH and other acute and chronic inflammatory and immunologic diseases such as AKI, AP, and AIPT. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. CalciMedica's expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks, and changes in circumstances, including but not limited to risks and uncertainties related to: the impact of fluctuations in global financial markets on CalciMedica's business and the actions it may take in response thereto; CalciMedica's ability to execute its plans and strategies; the ability to obtain and maintain regulatory approval for Auxora; results from clinical trials or preclinical studies may not be indicative of results that may be observed in the future; potential safety and other complications from Auxora; the scope, progress and expansion of developing and commercializing Auxora; the size and growth of the market therefor and the rate and degree of market acceptance thereof; economic, business, competitive, and/or regulatory factors affecting the business of CalciMedica generally; CalciMedica's ability to protect its intellectual property position; the impact of government laws and regulations; and CalciMedica's financial position and need for additional capital. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" in CalciMedica's Annual Report on Form 10-K for the year ended December 31, 2025, being filed with the Securities and Exchange Commission (SEC) later today, and elsewhere in CalciMedica's subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the SEC from time to time and available at . These documents can be accessed on CalciMedica's web page at ir.calcimedica.com/financials-filings/sec-filings. The forward-looking statements contained herein are made as of the date hereof, and CalciMedica undertakes no obligation to update them after this date, except as required by law. Contact Information Kevin Murphy [email protected] (212) 600-1902 SOURCE CalciMedica, Inc. 21% more press release views with Request a Demo

【制药网 行业动态】近年来，在医药行业创新发展的热潮下，众多药企已逐渐不再追求管线数量，而是开始集中资源投向潜力大、数据扎实或能成为“同类最优” 的少数项目。值得注意的是，以此同时，不少原本备受关注的药物开发也迎来了终止或暂停。 　　近日，赛诺菲在2025 年财报发布之际，确认停止了其代号为 SP0237 的六价 mRNA 流感疫苗项目。据了解，在去年赛诺菲的管线更新还显示，SP0237正在针对50岁及以上老年人进行I/II期临床试验，旨在评估其安全性和免疫原性。 　　业内认为，此次赛诺菲暂停mRNA流感疫苗项目，是在复杂环境下的战略调整，当然也不意味着要放弃mRNA这条技术路线。据悉，公司发言人曾表示，赛诺菲仍然致力于将mRNA技术作为多平台疫苗研发战略的关键组成部分。 　　1月30日，安进宣布终止与日本药企Kyowa Kirin(协和麒麟)关于自身免疫疾病候选药Rocatinlimab的合作协议，将全球权益全部归还协和麒麟。这意味着，其也将终止这款临床3期抗体药物开发。 　　据了解，Rocatinlimab(AMG451/KHK4083)是协和发酵麒麟开发的一款具有ADCC作用的阻断型OX40抗体，用于特应性皮炎、哮喘、结节性痒疹等疾病。根据公告，此次终止协议，是安进基于产品组合的战略优先级调整。但业内认为，rocatinlimab在与赛诺菲和再生元的重磅药物Dupixent的跨试验对比中没有显示出优势，商业化前景“中等”，或许也是安进放弃该药的关键原因之一。 　　1月28日，CalciMedica宣布终止其评估Auxora治疗急性肾损伤(AKI)患者的KOURAGE二期临床试验。 此决定是基于试验独立数据监测委员会(IDMC)的建议，该委员会在预定的中期数据审查中发现了安全问题。IDMC表示，该问题需要重新评估研究设计，特别是关于患者入组标准。 　　CalciMedicashi1一家临床阶段的生物制药公司，专注于开发新型钙释放激活钙(CRAC)通道抑制疗法治疗急性和慢性炎症和免疫性疾病。KOURAGE是一项随机，双盲，安慰剂对照的研究，预计将招募大约150名患有AHRF的2期和3期AKI患者，并将患者随机接受5天剂量的Auxora或安慰剂。 　　1月24日消息，辉瑞在ClinicalTrials平台更新了其靶向间皮素的ADC药物PF-08052666(又称HBM9033或SGN-MesoC2)的状态：从“招募中”变为“不招募”。该药物的全球I期临床试验于2024年8月启动，计划招募365例晚期实体瘤患者。然而，截至2026年1月12日最后一次更新，实际入组患者仅19例，远未达到原定目标。 　　业内人士透露，该药物临床试验已停止招募患者，这一决定基于纯粹的“业务战略原因”，与安全性问题、监管要求或试验障碍无关。据了解，该药物是和铂医药和宜联生物共同研发而成的，与辉瑞在2023年年底达成的一项潜在总价值高达11.3亿美元的重磅授权合作的核心资产。 　　…… 　　分析人士认为，2026 年大批药物开发被终止 / 暂停，主要是由于药企战略聚焦、临床数据不达标、资金链脆弱、监管趋严与赛道内卷等因素导致。未来，在行业从 “数量扩张” 转向 “质量优先”的发展背景下，药企研发管线将不断优化，资源也将进一步集中。其唯有提升管线质量、强化风险控制、优化合作与融资策略，才能在行业竞争中脱颖而出。 　　免责声明：在任何情况下，本文中的信息或表述的意见，均不构成对任何人的投资建议。