CalciMedica Reaches FDA Alignment on Phase 2b Trial Design for Auxora in Acute Pancreatitis

MT Newswires Live07-29

CalciMedica (CALC) said Wednesday it has reached alignment with the US Food and Drug Administration on the endpoints and patient selection criteria for a planned phase 2b trial of Auxora in acute pancreatitis.

The company said the regulator aligned on the new-onset severe respiratory failure as the primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints.

Alignment was also reached on a strategy to assess whether elevated lactate dehydrogenase can identify patients at greater risk of developing severe disease, CalciMedica said.

Results from the phase 2b trial are expected to help confirm patient selection criteria and inform the design and endpoint of a phase 3 program, the company said.

CalciMedica said it is engaging with a contract research organization and holding discussions with potential clinical sites for the study.

Shares of CalciMedica were up 1.4% in Wednesday trading.

Price: 0.74, Change: +0.01, Percent Change: +1.41

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2655189938?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-07-29 22:08","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2655189938","market":"sg","top_or_hot":-1,"title":"CalciMedica Reaches FDA Alignment on Phase 2b Trial Design for Auxora in Acute Pancreatitis","media":"MT Newswires Live","content":"<html><body><p> CalciMedica (CALC) said Wednesday it has reached alignment with the US Food and Drug Administration on the endpoints and patient selection criteria for a planned phase 2b trial of Auxora in acute pancreatitis.</p><p>The company said the regulator aligned on the new-onset severe respiratory failure as the primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints.</p><p>Alignment was also reached on a strategy to assess whether elevated lactate dehydrogenase can identify patients at greater risk of developing severe disease, CalciMedica said.</p><p>Results from the phase 2b trial are expected to help confirm patient selection criteria and inform the design and endpoint of a phase 3 program, the company said.</p><p>CalciMedica said it is engaging with a contract research organization and holding discussions with potential clinical sites for the study.</p><p>Shares of CalciMedica were up 1.4% in Wednesday trading.</p><p>Price: 0.74, Change: +0.01, Percent Change: +1.41</p></body></html>","source":"mtnewswires_news","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>CalciMedica Reaches FDA Alignment on Phase 2b Trial Design for Auxora in Acute Pancreatitis</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nCalciMedica Reaches FDA Alignment on Phase 2b Trial Design for Auxora in Acute Pancreatitis\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">MT Newswires Live </p>\n<p class=\"h-time\">2026-07-29 22:08</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> CalciMedica (CALC) said Wednesday it has reached alignment with the US Food and Drug Administration on the endpoints and patient selection criteria for a planned phase 2b trial of Auxora in acute pancreatitis.</p><p>The company said the regulator aligned on the new-onset severe respiratory failure as the primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints.</p><p>Alignment was also reached on a strategy to assess whether elevated lactate dehydrogenase can identify patients at greater risk of developing severe disease, CalciMedica said.</p><p>Results from the phase 2b trial are expected to help confirm patient selection criteria and inform the design and endpoint of a phase 3 program, the company said.</p><p>CalciMedica said it is engaging with a contract research organization and holding discussions with potential clinical sites for the study.</p><p>Shares of CalciMedica were up 1.4% in Wednesday trading.</p><p>Price: 0.74, Change: +0.01, Percent Change: +1.41</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4588","symbol_name":"碎股","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2655189938","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2655189938","pubTimestamp":1785334119,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. Better news, better service, better price.","home_visible":1,"id":"1092851196","head_image":"https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e"},"summary":"CalciMedica (CALC) said Wednesday it has reached alignment with the US Food and Drug Administration on the endpoints and patient selection criteria for a planned phase 2b trial of Auxora in acute panc","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4588":"碎股","BK4585":"ETF&股票定投概念","LABU":"三倍做多标普生物-Direxion","CALC":"CALCIMEDICA","BK4007":"制药"},"translate_title":"CalciMedica 就 Auxora 治疗急性胰腺炎的 2b 期试验设计获得 FDA 批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"LABU":1.5,"CALC":1},"content_text":"CalciMedica (CALC) said Wednesday it has reached alignment with the US Food and Drug Administration on the endpoints and patient selection criteria for a planned phase 2b trial of Auxora in acute pancreatitis.The company said the regulator aligned on the new-onset severe respiratory failure as the primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints.Alignment was also reached on a strategy to assess whether elevated lactate dehydrogenase can identify patients at greater risk of developing severe disease, CalciMedica said.Results from the phase 2b trial are expected to help confirm patient selection criteria and inform the design and endpoint of a phase 3 program, the company said.CalciMedica said it is engaging with a contract research organization and holding discussions with potential clinical sites for the study.Shares of CalciMedica were up 1.4% in Wednesday trading.Price: 0.74, Change: +0.01, Percent Change: +1.41","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":true,"editions":null,"column":"","sentiment":"1","news_tag":"executive","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"isLaohu8Offline":false,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.47.1","shortVersion":"4.47.1","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2655189938","isCrawlerRequest":true}