Cadrenal Therapeutics Provides 2024 Year-End Company Update, Reinforcing Clinical Development Plan for Tecarfarin in LVAD and Other Rare Cardiovascular Indications

Business Wire2024-12-31

PONTE VEDRA, Fla., December 31, 2024--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) today recapped its 2024 milestones and highlighted a clear path forward to develop the investigational...

Source Link

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/2495186216?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2024-12-31 21:00","share_image_url":"https://static.laohu8.com/5f26f4a48f9cb3e29be4d71d3ba8c038","id":"2495186216","market":"us","top_or_hot":-1,"title":"Cadrenal Therapeutics Provides 2024 Year-End Company Update, Reinforcing Clinical Development Plan for Tecarfarin in LVAD and Other Rare Cardiovascular Indications","media":"Business Wire","content":"<div>\n<p>PONTE VEDRA, Fla., December 31, 2024--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) today recapped its 2024 milestones and highlighted a clear path forward to develop the investigational...</p>\n\n<a href=\"https://finance.yahoo.com/news/cadrenal-therapeutics-provides-2024-end-130000663.html\">Source Link</a>\n\n</div>\n","source":"yahoofinance","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>Cadrenal Therapeutics Provides 2024 Year-End Company Update, Reinforcing Clinical Development Plan for Tecarfarin in LVAD and Other Rare Cardiovascular Indications</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\">\nCadrenal Therapeutics Provides 2024 Year-End Company Update, Reinforcing Clinical Development Plan for Tecarfarin in LVAD and Other Rare Cardiovascular Indications\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-12-31 21:00 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/cadrenal-therapeutics-provides-2024-end-130000663.html><strong>Business Wire</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>PONTE VEDRA, Fla., December 31, 2024--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) today recapped its 2024 milestones and highlighted a clear path forward to develop the investigational...</p>\n\n<a href=\"https://finance.yahoo.com/news/cadrenal-therapeutics-provides-2024-end-130000663.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"CSII","symbol_name":"Cardiovascular Systems","start_time":0,"source_url":"https://finance.yahoo.com/news/cadrenal-therapeutics-provides-2024-end-130000663.html","article_id":"2495186216","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2495186216","pubTimestamp":1735650000,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"PONTE VEDRA, Fla., December 31, 2024----Cadrenal Therapeutics, Inc.  today recapped its 2024 milestones and highlighted a clear path forward to develop the investigational drug tecarfarin as a superior and safer chronic anticoagulant therapy for warfarin-dependent patients with implanted cardiac devices including left ventricular assist devices  or for those with rare cardiovascular conditions.\"This year has marked significant opportunities and advancements for Cadrenal Therapeutics, with a strong focus on clinical indications,\" said Quang X. Pham, Chairman and Chief Executive Officer of Cadrenal Therapeutics. \"The Company has established a targeted plan to advance the clinical development of tecarfarin and, if approved, to commercialize it as a significant improvement for LVAD patients facing challenges with chronic anticoagulation treatments. We look ahead to 2025 and the initiation of the pivotal Phase 3 clinical trial for tecarfarin in LVAD and developing this much-needed therapeut","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"CSII":"Cardiovascular Systems","BK4082":"医疗保健设备","ODD":"ODDITY Tech Ltd.","CDMO":"Avid Bioservices, Inc.","BK4139":"生物科技","CVKD":"Cadrenal Therapeutics, Inc.","LENZ":"Therapeutics","BK4007":"制药","BK4183":"个人用品"},"translate_title":"Cadrenal Therapeutics提供2024年年终公司更新，强化替卡法林治疗LVAD和其他罕见心血管适应症的临床开发计划","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CDMO":1,"CSII":1,"LENZ":1,"ODD":1,"CVKD":0.9},"content_text":"PONTE VEDRA, Fla., December 31, 2024--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) today recapped its 2024 milestones and highlighted a clear path forward to develop the investigational drug tecarfarin as a superior and safer chronic anticoagulant therapy for warfarin-dependent patients with implanted cardiac devices including left ventricular assist devices (LVAD) or for those with rare cardiovascular conditions.\n\"This year has marked significant opportunities and advancements for Cadrenal Therapeutics, with a strong focus on clinical indications,\" said Quang X. Pham, Chairman and Chief Executive Officer of Cadrenal Therapeutics. \"The Company has established a targeted plan to advance the clinical development of tecarfarin and, if approved, to commercialize it as a significant improvement for LVAD patients facing challenges with chronic anticoagulation treatments. We look ahead to 2025 and the initiation of the pivotal Phase 3 clinical trial for tecarfarin in LVAD and developing this much-needed therapeutic solution for advanced heart failure patients with implanted LVADs.\"\n2024 Year-End Highlights:\n\nFDA Engagement and Tecarfarin Development: Cadrenal Therapeutics held a Type B meeting with the U.S. Food and Drug Administration (FDA) regarding the pivotal Phase 3 clinical trial protocol for tecarfarin in LVAD patients. The Company remains in discussion with the FDA to further refine the trial and expects to provide updates on the anticipated trial in Q1 2025.\nStrategic Development Collaborations: Cadrenal Therapeutics continues to explore collaboration with potential development partners to advance tecarfarin’s pivotal clinical trial for patients with LVAD and other rare cardiovascular conditions.\nFinancial Growth and Fundraising Success: Cadrenal Therapeutics raised approximately $9.8 million in recent financing transactions, including $5.1 million through an at-the-market (ATM) facility and $4.7 million from warrant exercises, boosting its cash balance to $11.3 million as of November 2024.\nIndustry Recognition and Engagement: In October 2024, Cadrenal Therapeutics joined the Corporate Council of the Anticoagulation Forum (AC Forum). This association will enable the Company to collaborate with anticoagulation therapy thought leaders and 15,000 healthcare professionals to improve anticoagulation outcomes for patients globally. In November 2024, Cadrenal Therapeutics was named Anticoagulation Therapy Company of the Year by Pharma Tech Outlook, an industry publication focused on breakthrough pharmaceutical technologies.\nOperational Milestones: The Company and its pharmaceutical Contract Development and Manufacturing Organization (CDMO) completed necessary operational readiness activities to supply clinical trial materials for the upcoming tecarfarin pivotal Phase 3 trial in compliance with current Good Manufacturing Practices (cGMP). Cadrenal Therapeutics has also conducted market research in multiple indications, including LVAD, research that reinforces Cadrenal Therapeutics’ commitment to continuing pre-commercial work for tecarfarin.\nOrphan Drug Designation for Tecarfarin: In April 2024, Cadrenal Therapeutics received FDA Orphan Drug Designation (ODD) for tecarfarin to prevent thromboembolism in patients with LVADs and other mechanical circulatory support devices, underscoring the investigational drug’s potential impact on rare cardiovascular conditions. Tecarfarin also has ODD and Fast Track designation from the FDA for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib).\nLeadership: Cadrenal appointed Jeff Cole as Chief Operating Officer to oversee manufacturing, supply chain operations, intellectual property, and commercialization strategies.\nScientific Advocacy and Clinical Evidence: The clinical need for tecarfarin was highlighted at the November 2024 European Association for Cardio-Thoracic Surgery (EACTS) Mechanical Circulatory Support Summit in an address by Mandeep R. Mehra, MD, The William Harvey Distinguished Chair in Advanced Cardiovascular Medicine and Professor, Harvard Medical School. Dr. Mehra presented compelling data on the limitations of warfarin for LVAD patients and the potential of tecarfarin, if approved, to provide a safer alternative to these patients.\n\nAbout Cadrenal Therapeutics\nCadrenal Therapeutics, Inc. is a biopharmaceutical company in advanced clinical development focused on developing tecarfarin, a novel oral and reversible anticoagulant for the prevention of heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions.\nTecarfarin is a vitamin K antagonist (VKA) potentially representing the first new therapeutic innovation in 70 years in VKA anticoagulation. Tecarfarin is designed to be a superior and safer chronic oral anticoagulant therapy compared to warfarin for patients with implanted cardiac devices or rare cardiovascular conditions.\nCadrenal Therapeutics’ drug candidate, tecarfarin, is expected to enter its pivotal Phase 3 trial during 2025. The Company’s clinical program for tecarfarin is supported by extensive data demonstrating the molecule’s potential as an alternative to warfarin, with safety data indicating fewer adverse events such as strokes, heart attacks, bleeds, and deaths in comparison with warfarin. The FDA granted tecarfarin orphan drug designation (ODD) for heart failure patients with implanted left ventricular assist devices (LVADs) as well as both ODD and Fast Track designation for end-stage kidney disease (ESKD) patients with atrial fibrillation (AFib).\nFor more information, please visit www.cadrenal.com and connect with the company on LinkedIn.\nSafe Harbor\nAny statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute \"forward-looking statements.\" These statements include statements regarding initiation of the pivotal Phase 3 clinical trial for tecarfarin in LVAD in 2025; providing updates on the anticipated trial in Q1 2025; continuing exploration of collaborations with potential development partners to advance tecarfarin’s pivotal clinical trial for patients with LVAD and other rare cardiovascular conditions; joining the Corporate Council of the Anticoagulation Forum enabling the Company to collaborate with anticoagulation therapy thought leaders and 15,000 healthcare professionals to improve anticoagulation outcomes for patients globally; and the potential of tecarfarin, if approved, to provide a safer alternative to LVAD patients. The words \"anticipate,\" \"believe,\" \"continue,\" \"could,\" \"estimate,\" \"expect,\" \"intend,\" \"may,\" \"plan,\" \"potentially,\" \"predict,\" \"project,\" \"should,\" \"target,\" \"will,\" \"would\" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to initiate the pivotal Phase 3 clinical trial for tecarfarin in LVAD patients in 2025 and provide trial updates as planned; the ability to enter into collaborations with development partners; the ability of tecarfarin to provide a safer alternative to LVAD patients and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20241231455225/en/\nContacts\nCorporate and Investor Relations Lisa DeScenzaLaVoieHealthScience(978) 395-5970ldescenza@lavoiehealthscience.com Media Andrew KordaLaVoieHealthScience(617) 865-0043akorda@lavoiehealthscience.com","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"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,"deviceId":"web-server-community-laohu8-v3","version":"4.30.2","shortVersion":"4.30.2","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/2495186216"}