Bivalirudin

Greater than 25% absolute reduction in thrombotic events with CAD-1005 versus placebo on a background of standard anticoagulant therapy, despite no difference in platelet count recovery End-of-Phase 2 Meeting Scheduled for March 2026 PONTE VEDRA, Fla., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced encouraging results from a Phase 2 trial evaluating CAD-1005 (formerly VLX-1005) in patients with heparin-induced thrombocytopenia (HIT), a severe pro-thrombotic reaction to heparin, the most commonly used parenteral anticoagulant. This randomized, blinded, placebo-controlled trial evaluated the safety and efficacy of CAD-1005, a selective inhibitor of 12-lipoxygenase (12-LOX), a critical immune signaling pathway implicated in HIT, in patients receiving standard anticoagulant therapy. To potentially validate a new surrogate endpoint, the previous investigational new drug sponsor, Veralox Therapeutics, selected platelet count recovery rate as the primary endpoint. Their trial did not meet this primary endpoint. The secondary endpoint was the incidence of new or worsening thrombotic events, including radiologic progression, which showed encouraging results. The study concluded in December 2025 following the transfer of program ownership from Veralox to Cadrenal. Although CAD-1005 did not significantly affect platelet recovery rate, CAD-1005-treated patients had fewer thrombotic events. Highlights: Primary Endpoint: Thrombotic events continued to occur even after platelet count recovery in both groups. Platelet recovery rates were similar between the CAD-1005 and placebo arms. Platelet count recovery did not appear to be a surrogate marker for clinical efficacy. Key Secondary Endpoint: A high rate of thrombotic events (>75%) was observed in the placebo group, with fewer thrombotic events in the CAD-1005 group (50%), although the study was not powered to detect statistical significance. Adding an inhibitor of 12-LOX to standard anticoagulants to block the immunological mechanisms driving HIT may be more effective than anticoagulants alone in preventing thrombotic events. Building on these secondary endpoint results, Cadrenal has been granted an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to align on a Phase 3 registration path. The Company considers this meeting a significant milestone in the development of CAD-1005, the only 12-LOX inhibitor in clinical development worldwide. “The encouraging trend toward reduced thrombotic events in the CAD-1005 treatment arm is strong support for the company’s decision to acquire this asset and rapidly progress its development,” said Quang X. Pham, CEO of Cadrenal Therapeutics. “Inhibition of 12-LOX is an exciting therapeutic frontier, potentially targeting numerous inflammatory, thrombotic, and metabolic conditions.” “We learned two very important things from this study, the only blinded placebo-controlled trial ever conducted in HIT,” said James Ferguson, MD, Chief Medical Officer of Cadrenal Therapeutics. “First, platelet count recovery was not an appropriate surrogate endpoint for clinical efficacy in a trial in which standard therapy event rates were strikingly high. Secondly, despite the relatively small number of patients, the reduction in thrombotic events with CAD-1005 is extremely encouraging. CAD-1005 could represent a major step forward as the only first-line therapy targeting the immune mechanisms responsible for HIT.” “Our field (HIT) is full of anticoagulant use in the absence of randomized prospective trials,” said Steven E. McKenzie, MD, PhD, Professor of Medicine at Thomas Jefferson University and a member of the study steering committee. “We are enthusiastic about CAD-1005 in addressing both the underlying immune mechanism and the unmet medical need for this serious thrombotic disorder.” Detailed trial results will be presented at a future scientific meeting. About Heparin-Induced Thrombocytopenia (HIT) Heparin is the most widely used in-hospital anticoagulant, with over 12 million patients receiving it in the United States each year. Heparin-induced thrombocytopenia (HIT) is a potentially life-threatening immune-mediated complication of heparin administration that occurs when antibodies to heparin activate platelets, leading to clots throughout the circulatory system, dramatically lowering platelet counts, and increasing the risk of bleeding. Complications of HIT include deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, amputation, and death, with mortality rates for HIT exceeding 20% in some studies. CAD-1005 is the only treatment in clinical development that targets the underlying immune drivers of HIT. About CAD-1005 CAD-1005 is an investigational therapy being evaluated for the treatment of suspected HIT. CAD-1005 is designed to selectively inhibit 12-LOX, a pathway integral to the primary immune mechanisms driving HIT. Unlike existing therapies for HIT, which are only directed at preventing thrombotic complications, this approach addresses the primary underlying cause of HIT. In preclinical models of HIT, CAD-1005 has been shown to prevent or treat HIT and halt the development of both thrombocytopenia and blood clots. The drug has not been associated with increased bleeding in animals or healthy human volunteers. CAD-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. About the Study The study was originally planned to enroll 60 patients, but was stopped in December 2025 after program ownership transferred to Cadrenal. Analysis of all existing trial data was recently completed. The final dataset includes 24 patients with a presumptive diagnosis of HIT, randomized to receive either CAD-1005 or a matching placebo; all patients received concomitant standard anticoagulant therapy, either argatroban or bivalirudin. The primary endpoint was the rate of platelet count recovery; a key secondary endpoint was the development of new or worsening thrombotic events, the composite of death, stroke, systemic embolism, myocardial infarction, deep venous thrombosis, superficial vein thrombosis, or skin necrosis. Primary analyses focused on 17 patients in whom HIT was confirmed by a central lab functional assay. About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is a first-in-class 12-LOX inhibitor for the treatment of heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also under development. The Company’s broader pipeline includes tecarfarin, a Phase 3-ready oral vitamin K antagonist for the treatment of patients with end-stage kidney disease and those with left ventricular assist devices, and frunexian, a parenteral, clinical-stage Factor XIa inhibitor designed for use in acute hospital settings. For more information, visit and connect with the Company on LinkedIn . Safe Harbor Any statements 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.” 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. These statements include adding an inhibitor of 12-LOX to standard anticoagulants to block the immunological mechanisms driving HIT being more effective than anticoagulants alone in preventing thrombotic events; the encouraging trend toward reduced thrombotic events in the CAD-1005 treatment arm being strong support for the Cadrenal’s decision to acquire this asset and rapidly progress its clinical development; full trial results being presented at a future scientific meeting; the reduction in thrombotic events with CAD-1005 being extremely encouraging, despite the relatively small number of patients; CAD-1005 representing a major step forward as the only first-line therapy targeting the immune mechanisms responsible for HIT; The EOP2 meeting being a significant milestone in the development of CAD-1005; CAD-1005 addressing both the underlying immune mechanism and the unmet medical need for this serious thrombotic disorder; the encouraging trend toward reduced thrombotic events in the CAD-1005 treatment arm being strong support for Cadrenal’s decision to acquire this asset and rapidly progress its development; CAD -1005 addressing the underlying immune drivers of HIT; and presenting detailed trial results at a future scientific meeting. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including Cadrenal’s ability to advance the clinical development of CAD-1005 for the treatment of HIT, including designing a pivotal Phase 3 registration study acceptable to the FDA; CAD-1005 having the ability to address the underlying immune mechanism and the unmet medical need for the serious thrombotic disorder; Cadrenal’s ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; Cadrenal’s ability to successfully complete clinical trials on time and achieve desired results and benefits as expected including support for CAD-1005’s potential to be a treatment option for HIT, Cadrenal’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, 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. For more information, please contact: Cadrenal Therapeutics: Matthew Szot, CFO press@cadrenal.com Investors: Lytham Partners, LLC Robert Blum, Managing Partner 602-889-9700 CVKD@lythampartners.com

1~8 批国采全国统一接续采购开始企业及产品申报啦！ 今日，《国家组织集采药品协议期满品种接续采购公告（第1号）》发布，按照国家医疗保障局统一部署，全国各省（自治区、直辖市）和新疆生产建设兵团组成采购联盟，委托江苏省、河南省和广东省牵头，遵循“稳临床、保质量、反内卷、防围标”原则，对原国家组织集采1-8批（不含胰岛素专项采购）协议期满的品种，开展全国统一接续采购工作。 据《公告》，本次接续采购医药机构需求量填报已完成，现启动企业及产品申报，具体目录如下（规格可点击「阅读原文」下载原始表格）： # 品种名称 1 阿托伐他汀口服常释剂型 2 瑞舒伐他汀口服常释剂型 3 氯吡格雷口服常释剂型 4 厄贝沙坦口服常释剂型 5 氨氯地平口服常释剂型 6 恩替卡韦口服常释剂型 7 艾司西酞普兰口服常释剂型 8 帕罗西汀口服常释剂型 9 奥氮平口服常释剂型 10 头孢呋辛酯（头孢呋辛）口服常释剂型 11 利培酮口服常释剂型 12 吉非替尼口服常释剂型 13 福辛普利口服常释剂型 14 厄贝沙坦氢氯噻嗪口服常释剂型 15 赖诺普利口服常释剂型 16 替诺福韦二吡呋酯口服常释剂型 17 氯沙坦口服常释剂型 18 依那普利口服常释剂型 19 左乙拉西坦口服常释剂型 20 伊马替尼口服常释剂型 21 孟鲁司特口服常释剂型 22 蒙脱石口服散剂 23 培美曲塞注射剂 24 氟比洛芬酯注射剂 25 右美托咪定注射剂 26 阿比特龙口服常释剂型 27 阿德福韦酯口服常释剂型 28 阿卡波糖口服常释剂型 29 阿莫西林口服常释剂型 30 阿奇霉素口服常释剂型 31 安立生坦片 32 奥美沙坦酯口服常释剂型 33 比索洛尔口服常释剂型 34 对乙酰氨基酚口服常释剂型 35 多奈哌齐口服常释剂型 36 氟康唑口服常释剂型 37 福多司坦口服常释剂型 38 格列美脲口服常释剂型 39 甲硝唑口服常释剂型 40 聚乙二醇口服散剂 41 坎地沙坦酯口服常释剂型 42 克林霉素口服常释剂型 43 铝碳酸镁咀嚼片 44 美洛昔康口服常释剂型 45 莫西沙星口服常释剂型 46 曲美他嗪缓释控释剂型 47 索利那新口服常释剂型 48 他达拉非片 49 特拉唑嗪口服常释剂型 50 替吉奥口服常释剂型 51 头孢氨苄口服常释剂型 52 头孢拉定口服常释剂型 53 辛伐他汀口服常释剂型 54 异烟肼口服常释剂型 55 吲达帕胺口服常释剂型 56 注射用紫杉醇（白蛋白结合型） 57 左西替利嗪口服常释剂型 58 阿那曲唑口服常释剂型 59 阿哌沙班口服常释剂型 60 阿扎胞苷注射剂 61 氨基葡萄糖口服常释剂型 62 氨溴索口服常释剂型 63 奥氮平口腔崩解片 64 奥美拉唑口服常释剂型 65 布洛芬缓释控释剂型 66 布洛芬颗粒剂 67 地氯雷他定口服常释剂型 68 多潘立酮口服常释剂型 69 二甲双胍缓释控释剂型 70 二甲双胍口服常释剂型 71 非布司他口服常释剂型 72 非那雄胺口服常释剂型 73 非那雄胺口服常释剂型 74 氟西汀口服常释剂型 75 枸橼酸西地那非片 76 甲钴胺口服常释剂型 77 卡培他滨口服常释剂型 78 卡托普利口服常释剂型 79 喹硫平口服常释剂型 80 来曲唑口服常释剂型 81 氯氮平口服常释剂型 82 美金刚口服常释剂型 83 孟鲁司特咀嚼片 84 孟鲁司特颗粒剂 85 匹伐他汀口服常释剂型 86 普芦卡必利口服常释剂型 87 曲美他嗪口服常释剂型 88 塞来昔布口服常释剂型 89 舍曲林口服常释剂型 90 坦洛新（坦索罗辛）缓释控释剂型 91 碳酸氢钠口服常释剂型 92 替格瑞洛口服常释剂型 93 托法替布口服常释剂型 94 维格列汀口服常释剂型 95 维生素B6口服常释剂型 96 西酞普兰口服常释剂型 97 西替利嗪口服常释剂型 98 缬沙坦口服常释剂型 99 盐酸达泊西汀片 100 依托考昔口服常释剂型 101 乙胺丁醇口服常释剂型 102 右佐匹克隆口服常释剂型 103 左乙拉西坦口服液体剂 104 左乙拉西坦注射用浓溶液 105 阿莫西林颗粒剂 106 利奈唑胺口服常释剂型 107 莫西沙星氯化钠注射剂 108 左氧氟沙星滴眼剂 109 环丙沙星口服常释剂型 110 头孢地尼口服常释剂型 111 头孢克洛口服常释剂型 112 克拉霉素口服常释剂型 113 埃索美拉唑（艾司奥美拉唑）口服常释剂型 114 氨磺必利口服常释剂型 115 氨溴索注射剂 116 奥洛他定滴眼剂 117 吡嗪酰胺口服常释剂型 118 丙泊酚中/长链脂肪乳注射剂 119 布洛芬口服常释剂型 120 布洛芬注射液 121 度洛西汀口服常释剂型 122 多索茶碱注射剂 123 恩格列净口服常释剂型 124 恩曲他滨替诺福韦口服常释剂型 125 格列齐特缓释控释剂型 126 加巴喷丁口服常释剂型 127 卡格列净口服常释剂型 128 喹硫平缓释控释剂型 129 洛索洛芬口服常释剂型 130 氯雷他定口服常释剂型 131 莫沙必利口服常释剂型 132 那格列奈口服常释剂型 133 帕瑞昔布注射剂 134 泮托拉唑口服常释剂型 135 泮托拉唑注射剂 136 培哚普利口服常释剂型 137 硼替佐米注射剂 138 普拉克索缓释控释剂型 139 普拉克索口服常释剂型 140 普瑞巴林口服常释剂型 141 羟苯磺酸口服常释剂型 142 瑞格列奈口服常释剂型 143 索拉非尼口服常释剂型 144 替格瑞洛口服常释剂型 145 替米沙坦口服常释剂型 146 替莫唑胺口服常释剂型 147 吸入用硫酸沙丁胺醇溶液 148 缬沙坦氨氯地平Ⅰ口服常释剂型 149 缬沙坦氢氯噻嗪口服常释剂型 150 伏立康唑口服常释剂型 151 诺氟沙星口服常释剂型 152 特比萘芬口服常释剂型 153 头孢丙烯口服常释剂型 154 左氧氟沙星口服常释剂型 155 玻璃酸钠滴眼剂 156 注射用比伐芦定 157 ω-3鱼油中/长链脂肪乳注射液 158 阿法骨化醇口服常释剂型 159 阿立哌唑口服常释剂型 160 阿昔洛韦口服常释剂型 161 埃索美拉唑（艾司奥美拉唑）注射剂 162 奥洛他定口服常释剂型 163 奥沙利铂注射剂 164 贝那普利口服常释剂型 165 贝他斯汀口服常释剂型 166 苯磺顺阿曲库铵注射剂 167 比卡鲁胺口服常释剂型 168 达比加群酯口服常释剂型 169 达比加群酯口服常释剂型 170 单硝酸异山梨酯缓释控释剂型 171 地西他滨注射剂 172 碘海醇注射剂 173 碘海醇注射剂 174 碘克沙醇注射剂 175 度他雄胺软胶囊 176 多西他赛注射剂 177 法舒地尔注射剂 178 复方异丙托溴铵吸入剂 179 格列吡嗪缓释控释剂型 180 格列吡嗪口服常释剂型 181 格隆溴铵注射液 182 更昔洛韦注射剂 183 枸橼酸氢钾钠颗粒 184 吉西他滨注射剂 185 兰索拉唑注射剂 186 乐卡地平口服常释剂型 187 利伐沙班口服常释剂型 188 利伐沙班口服常释剂型 189 利伐沙班口服常释剂型 190 硫辛酸注射剂 191 罗哌卡因注射剂 192 氯化钾缓释控释剂型 193 美托洛尔口服常释剂型 194 米格列醇口服常释剂型 195 米索前列醇口服常释剂型 196 帕洛诺司琼注射剂 197 沙格列汀口服常释剂型 198 文拉法辛缓释控释剂型 199 西那卡塞口服常释剂型 200 胸腺法新注射剂 201 异丙嗪口服常释剂型 202 异丙托溴铵吸入剂 203 脂肪乳氨基酸葡萄糖注射剂 204 中/长链脂肪乳注射剂 205 注射用盐酸苯达莫司汀 206 紫杉醇注射剂 207 阿奇霉素注射剂 208 布地奈德吸入剂 209 氟康唑注射剂型 210 利奈唑胺葡萄糖注射剂 211 莫西沙星滴眼剂 212 替硝唑口服常释剂型 213 头孢呋辛注射剂 214 头孢曲松注射剂 215 头孢他啶注射剂 216 头孢唑林注射剂型 217 左氧氟沙星注射剂型 218 阿法替尼口服常释剂型 219 阿立哌唑口腔崩解片 220 昂丹司琼注射剂 221 奥美拉唑注射剂 222 奥曲肽注射剂 223 奥司他韦口服常释剂型 224 吡格列酮口服常释剂型 225 丙酚替诺福韦口服常释剂型 226 醋酸钙口服常释剂型 227 单硝酸异山梨酯口服常释剂型 228 碘帕醇注射剂 229 厄洛替尼口服常释剂型 230 二甲双胍维格列汀口服常释剂型 231 氟桂利嗪口服常释剂型 232 氟哌噻吨美利曲辛口服常释剂型 233 磺达肝癸钠注射剂 234 甲磺酸仑伐替尼胶囊 235 咖啡因注射剂 236 拉考沙胺口服常释剂型 237 来氟米特口服常释剂型 238 利多卡因注射剂 239 罗库溴铵注射剂 240 吗替麦考酚酯口服常释剂型 241 美托洛尔缓释剂型 242 米力农注射剂 243 帕立骨化醇注射剂 244 帕洛诺司琼注射剂 245 普萘洛尔口服常释剂型 246 舒尼替尼口服常释剂型 247 特布他林吸入剂 248 替罗非班注射剂型 249 硝苯地平缓释剂型 250 硝苯地平控释剂型 251 盐酸鲁拉西酮片 252 盐酸美金刚缓释胶囊 253 伊班膦酸注射剂 254 伊立替康注射剂 255 依巴斯汀口服常释剂型 256 依达拉奉注射剂型 257 依替巴肽注射剂 258 依折麦布口服常释剂型 259 注射用替莫唑胺 260 唑来膦酸注射剂 261 唑来膦酸注射剂 262 甲泼尼龙口服常释剂型 263 甲泼尼龙注射剂 264 甲泼尼龙注射剂 265 奥硝唑口服常释剂型 266 克林霉素磷酸酯注射剂 267 罗红霉素口服常释剂型 268 头孢克洛口服液体剂 269 头孢克肟颗粒剂 270 头孢克肟口服常释剂型 271 头孢美唑注射剂型 272 头孢米诺注射剂 273 美罗培南注射剂 274 米卡芬净注射剂 275 替加环素注射剂 276 头孢吡肟注射剂型 277 阿加曲班注射剂 278 阿托西班注射剂 279 氨甲环酸注射剂型 280 氨氯地平阿托伐他汀口服常释剂型 281 丙氨酰谷氨酰胺注射剂 282 丙戊酸钠注射剂 283 非洛地平非洛地平Ⅱ缓释控释剂型 284 呋塞米注射剂 285 骨化三醇口服常释剂型 286 甲钴胺注射剂 287 奥司他韦干混悬剂 288 氯沙坦氢氯噻嗪口服常释剂型 289 米氮平口服常释剂型 290 那屈肝素(那曲肝素)注射剂 291 生长抑素注射剂 292 酮咯酸氨丁三醇注射剂 293 托拉塞米注射剂 294 熊去氧胆酸口服常释剂型 295 奥普力农注射剂 296 依诺肝素注射剂 297 左氨氯地平(左旋氨氯地平)口服常释剂型 298 左布比卡因注射剂 299 左卡尼汀注射剂 300 阿莫西林克拉维酸口服常释剂型 301 阿莫西林克拉维酸注射剂 302 氨曲南注射剂 303 奥硝唑注射剂型 304 复方磺胺甲噁唑口服常释剂型 305 甲硝唑注射剂型 306 利福平利福平Ⅱ口服常释剂型 307 头孢地尼颗粒剂 308 头孢西丁注射剂型 309 头孢地嗪注射剂 310 比阿培南注射剂 311 达托霉素注射剂 312 伏立康唑注射剂 313 哌拉西林他唑巴坦注射剂 314 头孢哌酮舒巴坦注射剂 315 头孢噻肟注射剂 申报时间及方式 企业及产品申报提交时间：2026年1月23日-2026年2月2日17时。 修改或补充材料时间：2026年1月23日-2026年2月3日17时前。 《公告》说明，未在相应规定的时间内完成申报提交和修改、补充材料的，视为放弃参与本次接续采购。截止时间如有调整，以后续公告为准。 近日热点阅读： 2026，医药代表的三大危机 只会“讲药”的医药代表，没有市场了 A司再度上榜！不服不行 勃林格荣膺“中国杰出雇主” 上药天普荣膺中国杰出雇主认证 医药行业三大央企披露高管年薪 安斯泰来蝉联“中国杰出雇主” 欧加隆蝉联“中国杰出雇主” 费卡中国连续荣膺中国杰出雇主 赵萍：跨国药企的“赢”，如何书写？ 一药企被诉拖欠研发费用 这些药企上榜创新药“华山奖” 通化东宝任命两名副总裁 日本药企2026涨薪幅度定了 医保支持创新，国产好药加速惠及患者 跨国药企裁员，近190名医药代表面临失业 明年3月，6000+医药精英赴约 西贝这事儿，医药老炮儿怎么处理？ 这家药企年会放大招！把医药人看酸了 中国医药又查一人 多家药企，高管变动 医药代表的五种类型，你属于哪一类？ 打通肥胖管理“最后一公里”，诺和诺德行动了 4个药品，暂停采购 年薪曾达870万元，一药企CEO辞职 医药巨头，再次补税三千多万 徐向平辞任九芝堂副总经理 拜耳中国12月热招岗位 费森尤斯卡比全国职位大放送 辉瑞中国成立新事业部，全国岗位 网红A司，风口加速扩招中 最新药企内部招聘（1月22日更新） #跨国药企在进博会 医药代表 伴您成长！