CVKD

PONTE VEDRA, Fla., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, announced that CEO Quang X.

FDA Alignment on Primary Endpoint and Path Forward for Phase 3 Registration Study CAD-1005 Targets a Significant Unmet Need, with Approximately 50,000 Confirmed Acute HIT Diagnoses Annually in the U.S. and an Estimated $2 Billion in Peak Annual Revenue Opportunity PONTE VEDRA, Fla., Aug. 31, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, today announced positive feedback from a Type D Meeting with the U.S. Food and Drug Administration (FDA) held on July 28, 2026.

Late-breaking Phase 2 CAD-1005 data presented at ISTH support a late-stage portfolio organized around preoperative safety, orphan regulatory acceleration, and postoperative shielding Late-breaking Phase 2 CAD-1005 data presented at ISTH support a late-stage portfolio organized around preoperative safety, orphan regulatory acceleration, and postoperative shielding

Urgent  Need for Novel Targets - Recent clinical failure of a competing mechanism highlights urgent need for novel upstream targets, such as 12-LOX, that are being studied to address the root causes of cardio-renal injury Dual-Indication Development and Commercialization Strategy Expands the Clinical Advancement of CAD-1005 to target both Heparin-Induced Thrombocytopenia (HIT) and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) Addresses  High-Value Gap in the Acute Care Market –First-in-class positioning in the $1 billion+ U.S. CSA-AKI market following the recent discontinuation of a competitor's late-stage Phase 3 clinical trial for lack of efficacy Global Partnering Potential – Leverages shared in-hospital ICU infrastructure and intravenous (IV) presentation to deliver a critical care asset package PONTE VEDRA, Fla., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, announced a consolidation of its multi-indication strategy for its Cardiac Acute Critical Care (CACC) Franchise, with a focus on CAD-1005 for both HIT and CSA-AKI.

Capital-efficient strategy focuses on differentiated therapies for cardiac pre- and post-operative critical care and orphan cardiovascular conditions Company is exploring development, licensing, and commercialization partnerships for CAD-1005, frunexian, and tecarfarin Recently presented Phase 2 CAD-1005 data demonstrated a >25% absolute reduction in thrombotic events in patients with heparin-induced thrombocytopenia PONTE VEDRA, Fla., July 21, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, today announced a comprehensive alignment of its clinical portfolio into a Cardiac Acute Critical Care Franchise.

Selected as one of three late-breakthrough abstracts: clinical trials and innovation in thrombosis, CAD-1005 took center stage before the global thrombosis community at the largest ISTH meeting in more than a decade. Oral presentation by Principal Investigator Dr. Steven E.

$3 million upfront with up to approximately $5.8 million of potential additional gross proceeds upon the exercise in full of warrants

Selection highlights the clinical value potential of Cadrenal's first-in-class 12-lipoxygenase inhibitor for Heparin-Induced Thrombocytopenia (HIT) First-ever randomized, blinded, placebo-controlled trial in HIT, a life-threatening blood-clotting disorder triggered by an immune reaction to heparin, the most widely used blood thinner in hospitals Phase-3 ready and addresses a peak $2 billion annual revenue potential in the HIT market PONTE VEDRA, Fla., June 24, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing late-stage novel therapies for life-threatening immune and thrombotic conditions, today announced that late-breaking clinical data on its first-in-class 12-lipoxygenase (12-LOX) inhibitor, CAD-1005 (formerly VLX-1005), have been accepted for a prestigious oral presentation at the 34th Congress of the International Society on Thrombosis and Haemostasis (ISTH).

Company to present Phase 3-ready pipeline, 12-LOX platform, and pediatric rare-disease expansion to global pharmaceutical partners at the 2026 BIO International Convention in San Diego Kawasaki disease is the leading cause of acquired heart disease in children in developed nations. Patients are at risk of forming blood clots in coronary arteries and may require lifelong treatment If the designation is granted and tecarfarin is approved for this indication, Cadrenal would be eligible to receive a Priority Review Voucher—recent open-market valuations for these vouchers have reached into the ~$200 million range PONTE VEDRA, Fla.

New high-value indication for Phase 3-ready asset with data intended to support clinical development and strategic partnering discussions Additional billion-dollar target- Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI), a serious complication affecting 35,000 U.S. patients annually, with no approved FDA-approved targeted therapies Dual-Purpose Synergy - Planned Phase 2a proof-of-concept trial expected to generate safety, renal injury signals, and 12-LOX pathway biology in high-risk cardiac surgery patients, while generating high-value data potentially relevant to the Company's lead HIT indication Capital-Efficient Development: Leverages shared in-hospital ICU infrastructure and an intravenous (IV) formulation to offer a turnkey critical care franchise for a global pharmaceutical partner Maximizes 12-LOX Platform Valuation – Strongly positioned for upcoming strategic collaboration and licensing meetings at BIO 2026 PONTE VEDRA, Fla., June 15, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced that it plans to initiate a Phase 2a proof-of-concept clinical trial of its lead drug candidate, CAD-1005, being studied to prevent Acute Kidney Injury (AKI) in high-risk patients undergoing cardiac surgery.