Cadrenal Therapeutics Announces Phase 2 Results with Encouraging Reductions in Thrombotic Events for CAD-1005 in HIT, Supporting Clinical Advancement
Rhea-AI Summary
Cadrenal Therapeutics (Nasdaq: CVKD) reported Phase 2 results for CAD-1005 in heparin-induced thrombocytopenia (HIT) showing a >25% absolute reduction in thrombotic events versus placebo on top of standard anticoagulant therapy, despite no improvement in platelet count recovery. An End-of-Phase 2 FDA meeting is scheduled for March 2026 to align on a Phase 3 path. The trial was randomized, blinded, placebo-controlled and concluded in December 2025 after program transfer from Veralox. Detailed data will be presented at a future scientific meeting.
Positive
- Thrombotic events reduced by >25% absolute versus placebo
- End-of-Phase 2 FDA meeting granted for March 2026
- CAD-1005 is the only 12-LOX inhibitor in clinical development worldwide
Negative
- No difference in platelet count recovery between CAD-1005 and placebo
- Study not powered for statistical significance on thrombotic endpoint
- Placebo arm experienced a high thrombotic event rate (>75%)
Market Reaction – CVKD
Following this news, CVKD has gained 8.79%, reflecting a notable positive market reaction. Argus tracked a peak move of +8.7% during the session. Our momentum scanner has triggered 10 alerts so far, indicating notable trading interest and price volatility. The stock is currently trading at $7.30. This price movement has added approximately $1M to the company's valuation.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.
Key Figures
Market Reality Check
Peers on Argus
Biotech peers with high affinity scores (e.g., ALLR, TENX, DARE, NEUP, NRSN) were down between about -0.58% and -3.19%, while only one scanned peer (ITRM) appeared in momentum with a 7.13% gain and no news. This points to stock-specific drivers rather than a broad sector move.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Aug 05 | Trial initiation plans | Positive | +23.7% | Planned tecarfarin trials for ESKD patients transitioning to dialysis. |
| May 15 | Manufacturing progress | Positive | +7.1% | cGMP manufacturing milestones supporting tecarfarin clinical readiness. |
| Feb 06 | CMO transition | Neutral | -3.3% | New CMO appointed to lead late-stage tecarfarin development. |
| Dec 31 | Year-end update | Positive | +1.8% | Orphan status, fundraising, and Phase 3 readiness for tecarfarin. |
Clinical-development headlines for tecarfarin have often coincided with positive price reactions, suggesting the market tends to reward clear advancement steps, though leadership-related news showed one negative reaction.
Over the past year, Cadrenal’s clinical news flow has centered on tecarfarin. A Dec 31, 2024 year-end update highlighted FDA Orphan Drug designation, cash of $11.3M, and Phase 3 readiness. Subsequent 2025 items included a CMO transition to advance pivotal trials, manufacturing progress to support readiness, and plans to initiate trials in ESKD patients. Against this backdrop, today’s HIT Phase 2 data for CAD-1005 adds a second, immune-driven anticoagulation program alongside tecarfarin’s chronic cardiovascular focus.
Historical Comparison
In the past year, four clinical-development updates averaged a 7.33% move, with most positive trial-readiness milestones drawing favorable reactions. This HIT Phase 2 readout fits the pattern of clinically focused catalysts driving interest.
Historical clinical items show tecarfarin advancing from year-end Phase 3 readiness, through CMO transition, to manufacturing and trial initiation plans. Today’s HIT Phase 2 results extend that trajectory by adding later-stage, immune-mediated anticoagulation data alongside the tecarfarin program.
Market Pulse Summary
The stock is up +8.8% following this news. A strong positive reaction aligns with prior clinical milestones that often drew favorable interest, where similar updates averaged moves of about 7.33%. The HIT data show a >25% absolute reduction in thrombotic events and support an End-of-Phase 2 meeting in March 2026. However, prior filings highlighted liquidity constraints and going‑concern language, which could temper enthusiasm if funding needs resurface.
Key Terms
heparin-induced thrombocytopenia medical
thrombotic events medical
12-lipoxygenase medical
placebo-controlled technical
surrogate endpoint medical
End-of-Phase 2 regulatory
investigational new drug regulatory
AI-generated analysis. Not financial advice.
Greater than
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
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 https://www.cadrenal.com/ 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
FAQ
What were the February 24, 2026 Phase 2 results for CAD-1005 (CVKD) in HIT?
Why is the End-of-Phase 2 FDA meeting in March 2026 important for CVKD and CAD-1005?
Did CAD-1005 (CVKD) improve platelet count recovery in the Phase 2 HIT trial?
How clinically meaningful is the thrombotic event reduction reported by Cadrenal (CVKD)?
What does CAD-1005 target and why is that relevant for HIT patients (CVKD)?
When did the CAD-1005 Phase 2 trial conclude and who previously sponsored the program (CVKD)?
