CVKD

Official FDA meeting minutes and Phase 2 data provide guidance on the pivotal Phase 3 registration path for CAD-1005 in heparin-induced thrombocytopenia (HIT) PONTE VEDRA, Fla., May 07, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today reported its financial results for the first quarter ended March 31, 2026, and provided a corporate update highlighting continued progress in its CAD-1005 program for HIT. The Company has now received the official minutes from its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), which provided guidance on key elements of the planned pivotal Phase 3 registration trial for CAD-1005, Cadrenal's investigational first-in-class 12-lipoxygenase (12-LOX) inhibitor being developed to treat suspected heparin-induced thrombocytopenia (HIT). Based on this feedback and Phase 2 data, Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to standard-of-care anticoagulation in patients with HIT. Recent Highlights Received official FDA EOP2 meeting minutes providing guidance on protocol design, study population, dosing, background therapy, exposure, safety database, and the primary endpoint of new or worsening thrombotic events. After considering FDA feedback on a pivotal registration study, Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT. Planned pivotal Phase 3 study, the first randomized, blinded, placebo-controlled registration trial in HIT, will evaluate CAD-1005 in approximately 120 patients across clinical centers worldwide and is intended to support a projected NDA submission in 2029. Primary endpoint, centrally adjudicated, is expected to be the incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT, with at least one planned interim analysis. Phase 2 data showed an absolute reduction of more than 25% in thrombotic events when CAD-1005 was added to standard anticoagulant therapy, supporting the continued advancement of CAD-1005 as Cadrenal's near-term development priority. Continues to position CAD-1005 as a first-in-cla...

By David Bautz, PhD NASDAQ: CVKD READ THE FULL CVKD RESEARCH REPORT Business Update Published Results Show Potential for 12-LOX Inhibition in Obesity and Type 2 Diabetes On March 12, 2026, Cadrenal Therapeutics, Inc. (NASDAQ: CVKD) announced the publication of preclinical research findings that show the potential for its first-in-class 12-lipoxygenase (12-LOX) inhibitor, CAD-1005, as a treatment for the inflammatory effects of obesity and type 2 diabetes (T2D). The progression of obesity and T2D has previously been linked to signaling by the products of 12-LOX enzymes (Kulkarni et al., 2021). The LOX enzymes are responsible for the oxygenation of polyunsaturated fatty acids to form eicosanoids, with 12-LOX producing the pro-inflammatory metabolite 12-hydroxyeicosatetraenoid acid (12-HETE). The main 12-LOX enzyme that produces 12-HETE is encoded by the ALOX12 gene, however human 12-LOX is structurally distinct from its mouse orthologue so inhibitors of human 12-LOX can’t be tested in mice. Thus, the current study utilized a human gene replacement mouse model in which the mouse 12-LOX gene (Alox15) was replaced by the human ALOX12 gene prior to placing male mice on a high-fat diet and then treating with CAD-1005 (VLX-1005) (Kaylan et al., 2026). This work builds upon previously published research showing that VLX-1005 delayed the onset of autoimmune diabetes and reduced islet inflammation in nonobese diabetic mice in which human ALOX12 replaced mouse Alox15 (Nargis et al., 2024). The results of the study showed that treatment with VLX-1005 improved glucose homeostasis, reduced β-cell dedifferentiation, and alleviated macrophage-mediated inflammation in both pancreatic islets and adipose tissue. The decreased β-cell dedifferentiation was shown by a decrease in ALDH1A3 expression, which is a marker of β-cell failure and reduced glucose-stimulated insulin secretion (Kim-Muller et al., 2016). The decrease in ALDH1A3 following VLX-1005 treatment suggests that the drug improves β-cell health and may contribute to increased capacity to meet insulin secretory needs. Treatment with VLX-1005 also reduced macrophage infiltration and cytokine expression in adipose tissue, which are both implicated in obesity-associated inflammatory responses (Russo et al., 2018). While Cadrenal continues to be fully focused on advancing CAD-1005 as a treatment for heparin-induced thromboc...

Encouraging Phase 2 HIT data and recent FDA feedback support continued advancement of CAD-1005 as Cadrenal’s near-term development priority; broader 12-LOX platform remains a longer-term opportunity PONTE VEDRA, Fla., March 31, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today reported its financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update highlighting recent progress across its CAD-1005 program for HIT and broader 12-LOX inhibitor platform. The update reflects continued progress for CAD-1005, Cadrenal’s first-in-class 12-LOX inhibitor for suspected heparin-induced thrombocytopenia (HIT), including completion of its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) on March 26, 2026, to align on the proposed Phase 3 pivotal trial of CAD-1005 in patients with HIT. Recent Highlights Reported encouraging results from a randomized, blinded, placebo-controlled Phase 2 study of CAD-1005 in HIT, with fewer new or worsening thrombotic events observed in patients treated with CAD-1005 on a background of standard anticoagulant therapy. Observed a greater than 25% absolute reduction in thrombotic events in the CAD-1005 treatment arm versus placebo, while also gaining important insight that platelet count recovery may not be an appropriate surrogate endpoint for clinical efficacy in HIT. On March 26, 2026, the Company completed its End-of-Phase 2 meeting with the FDA and clarified a potential registrational path for its planned Phase 3 pivotal trial. Incorporation of FDA feedback into Phase 3 protocol is currently underway. Continued to position CAD-1005 as the only selective 12-LOX inhibitor currently in clinical development, supported by Orphan Drug and Fast Track designations from the FDA and orphan drug status from the European Medicines Agency. While HIT remains the Company’s near-term development priority, it continues to see additional scientific support for 12-LOX inhibition beyond HIT, including research in obesity and type 2 diabetes showing potential improvements in glycemic control, pancreatic beta-cell preservation, and inflammatory signaling. “CAD-1005 continues to reinforce our conviction that selective 12-LOX inhibition may...

By David Bautz, PhD NASDAQ:CVKD READ THE FULL CVKD RESEARCH REPORT Business Update Encouraging Results from Phase 2 HIT Trial On February 24, 2026, Cadrenal Therapeutics, Inc. (NASDAQ:CVKD) announced encouraging results from the Phase 2 trial of CAD-1005 (formerly CAD-1005) in heparin-induced thrombocytopenia (HIT). The results showed a meaningful reduction in thrombotic events despite not meeting the study’s primary endpoint of platelet count recovery. While platelet recovery did not differ between treatment groups, thrombotic events occurred in 50% of CAD-1005-treated patients compared with >75% in placebo-treated patients, which represents a >25% absolute reduction. Although the study was not powered for statistical significance, the signal is clinically compelling in a condition with a high morbidity and mortality, and no approved therapies specifically targeting the immune mechanism underlying HIT. The randomized, placebo controlled Phase 2 study evaluated CAD-1005, a selective inhibitor of 12-lipoxygenase (12-LOX) in patients with suspected HIT receiving standard anticoagulant therapy (argatroban or bivalirudin). The trial was initiated by Veralox Therapeutics, which selected platelet count recovery rate as the primary endpoint. The strategic intent of that design was to determine whether platelet count recovery could serve as a surrogate endpoint for clinical outcomes in a future registrational study. In other words, the Phase 2 trial was structured not only to evaluate efficacy, but to test whether platelet count recovery could reliably predict reductions in thrombotic events. Following the acquisition by Cadrenal, the study concluded with 24 randomized patients, 17 of whom had centrally confirmed HIT. The study did not demonstrate a difference in platelet count recovery between treatment arms. In addition, thrombotic events continued to occur even after platelet count recovery in both arms. This indicates that platelet count recovery may not function as a reliable surrogate marker for clinical efficacy in HIT, particularly in a setting where background event rates remain high despite standard anticoagulation. Rather than representing a setback for CAD-1005, the results help to clarify endpoint strategy. The study successfully answered the scientific question it was designed to address: platelet count recovery does not appear to predict thrombotic ou...

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 Ad...

PONTE VEDRA, Fla., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome current gaps in anticoagulation therapy, today reported its financial results for the third quarter ended September 30, 2025, and provided an update on the clinical development of tecarfarin and the acquisition and development of frunexian. Highlights Progressed clinical development of tecarfarin. Completed the manufacturing of tecarfarin drug product in accordance with current good manufacturing practices (cGMP). Ongoing activities in support of a single-site U.S. Phase 2 study of tecarfarin in LVAD patients as part of the collaboration agreement with Abbott. Investigator discussions for a potential multi-site Phase 2 study of tecarfarin in dialysis patients already treated with warfarin. Expanded Cadrenal’s portfolio through the acquisition of the assets of eXIthera Pharmaceuticals, including its proprietary portfolio of investigational intravenous (IV) and oral Factor XIa inhibitors, in September 2025. The lead asset, frunexian, is a first-in-class, Phase 2-ready IV Factor XIa inhibitor designed for acute care settings where contact activation of coagulation by medical devices plays a significant role, such as cardiopulmonary bypass, catheter thrombosis, and other blood-contacting implanted cardiac devices. “We have uniquely positioned ourselves to address gaps in anticoagulation treatment of multiple indications through the development of two differentiated anticoagulants (tecarfarin and frunexian) while benefitting from pathways that provide clear regulatory designations,” commented Quang X. Pham, Chairman & CEO. “Having multiple pathways has allowed us to be prudent and flexible in our strategic approach to achieving critical development milestones as we look to advance our therapies for patients where conventional anticoagulation does not provide sufficient safety or efficacy.” “Our focus as we finish 2025 is the progression of tecarfarin into clinical applications where significant anticoagulation challenges exist,” Pham continued. “We are in discussions with key partners to move forward a development strategy which we believe is critical to the broader anticoagulation industry to address gaps in care and unlock key value for shareholders.” Third Quarter 2025 Financial Highligh...

Announces strategic clinical trial plans for tecarfarin in patients with End-Stage Kidney Disease (ESKD) transitioning to dialysis Tecarfarin can potentially address critical treatment gaps in patients with ESKD Pivotal step forward in pursuit of ESKD + Atrial Fibrillation (AFib) registration trial PONTE VEDRA, Fla., August 11, 2025--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company focused on developing transformative therapeutics that specifically address limitations of current anticoagulation therapy, today reported its financial results for the second quarter ended June 30, 2025, and provided an update on the strategic focus of the company and clinical development of tecarfarin. "We continue to advance our goal of developing transformative therapeutics to address the gaps in current anticoagulation therapy for patients with complex needs," said Quang X. Pham, Chairman & CEO. "This commitment is reflected in our strategic plan to initiate a clinical trial for tecarfarin in end-stage kidney disease (ESKD) for patients transitioning to dialysis. There is a critical need for safe, effective anticoagulants for use in ESKD patients, and tecarfarin’s orphan drug and fast-track designations in ESKD patients with atrial fibrillation (AFib) underscore this need. We are very excited to advance this program." "Strong operational execution is fundamental to advancing tecarfarin into late-stage trials," continued Pham. "By successfully completing the technical transfer of tecarfarin to a U.S. site of a leading global CDMO and manufacturing tecarfarin drug product, we have achieved critical steps in CMC readiness to supply our planned clinical trial and execute our development strategy." Highlights from the Quarter Ended June 30, 2025, and Other Recent Events: Clinical Trial Developments In August 2025, Cadrenal announced plans to initiate a clinical trial for its late-stage drug candidate, tecarfarin, in patients with ESKD who are transitioning to dialysis, including those with and without atrial fibrillation (AFib). Site activation and screening for patient enrollment are planned to begin later this year. The need is urgent for this population, as patients with severe kidney disease are at high risk for thrombotic cardiovascular events such as myocardial infarction and stroke, along with a much greater risk of AFib and venous th...

Leadership appointment strengthens strategic and development capabilities FDA Type D Meeting provides additional guidance for advancing the clinical development of tecarfarin Collaboration Agreement with Abbott (NYSE: ABT) validates the need for new anticoagulation options PONTE VEDRA, Fla., May 08, 2025--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today reported its financial results for the first quarter ended March 31, 2025, and provided an update on the strategic focus of the company and clinical development of tecarfarin. "In the first quarter of 2025, Cadrenal continued to build on the momentum we achieved during 2024," said Quang X. Pham, Chairman & CEO. "The appointment of James Ferguson, M.D., FACC, FAHA, as our Chief Medical Officer positions us for success in reviewing potential assets to add to our portfolio and designing and executing our clinical program for tecarfarin. The finalized Collaboration Agreement with Abbott validates the critical need in the market for a new anticoagulant for patients with left ventricular assist devices (LVADs). And our meeting with the FDA provided additional guidance in the design of a pivotal trial." Highlights from the Quarter Ended March 31, 2025, and Other Recent Events: Leadership Advances In February 2025, Cadrenal appointed James J. Ferguson, M.D., FACC, FAHA, as Chief Medical Officer to lead the review of business development opportunities to expand the Company’s pipeline and drive the late-stage clinical development of tecarfarin for conditions requiring chronic anticoagulation therapy. Regulatory Update In February 2025, Cadrenal met with the U.S. Food and Drug Administration (FDA) for a Type D meeting. The FDA provided additional guidance on the appropriate design for a Phase 3 tecarfarin trial and welcomed submission of a final study design for review. Collaboration Agreement with Abbott In March 2025, we announced a Collaboration Agreement with Abbott (NYSE: ABT) to support our pivotal TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial. Under the agreement, Abbott will share insights from recent HeartMate 3™ clinical trials and will support Cadrenal with trial design, site identification, trial awareness, and HeartMate 3™ expertise. Operat...

Recent Collaboration Agreement with Abbott Global Enterprises Limited ("Abbott") in support of Phase 3 randomized, multicenter study, entitled TECH-LVAD Recent FDA Type D Meeting provides additional guidance for advancing clinical development of tecarfarin Leadership appointments to strengthen development capabilities PONTE VEDRA, Fla., March 13, 2025--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company focused on the development of tecarfarin, a new Phase 3 ready oral vitamin K antagonist, today reported full year results for the period ended December 31, 2024, and provided a business update and highlights of the path forward for the clinical advancement of tecarfarin. "2024 for Cadrenal was a year of focus and laying the foundations for advancing tecarfarin into Phase 3 clinical development. With our eyes squarely centered on unmet needs in anticoagulation therapy, we have made strong progress on the partnering, regulatory, and financing fronts," said Quang X. Pham, Chairman & CEO. "Throughout 2025, our primary focus is on execution, as we move forward to assessing the efficacy and safety of tecarfarin in patients with left ventricular assist devices (LVAD) and consider other important areas of unmet need that a more reliable vitamin K antagonist could address." Full Year 2024 Key Accomplishments and Recent Highlights Collaboration Agreement with Abbott On March 4, 2025, we announced a Collaboration Agreement with Abbott (NYSE: ABT) to support Cadrenal’s pivotal TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial. Under the agreement, Abbott will share insights from recent HeartMate 3™ clinical trials and will support Cadrenal with trial design, site identification, trial awareness, and HeartMate 3™ expertise. TECH-LVAD Trial Update On February 3, 2025, the Company had a Type D meeting with the U.S. Food and Drug Administration (FDA). The FDA provided additional guidance on the design of a future Phase 3 trial of tecarfarin and has requested the Company provide a full study design synopsis and detailed clinical trial design for review. Leadership Advances Cadrenal appointed James J. Ferguson, MD, FACC, FAHA, as Chief Medical Officer to lead the late-stage clinical development of tecarfarin and other indications in rare cardiovascular conditions requiring life-long anti...