Cadrenal Therapeutics Announces Positive Outcome from FDA Type D Meeting for Phase 3 Registration Study of CAD-1005 in Heparin-Induced Thrombocytopenia

Cadrenal Therapeutics (Nasdaq: CVKD) reported a positive outcome from a July 28, 2026 FDA Type D meeting on the Phase 3 registration study of CAD-1005, a first-in-class 12-lipoxygenase inhibitor in development for heparin-induced thrombocytopenia (HIT).

Rhea-AI Summary

Cadrenal Therapeutics (Nasdaq: CVKD) reported a positive outcome from a July 28, 2026 FDA Type D meeting on the Phase 3 registration study of CAD-1005, a first-in-class 12-lipoxygenase inhibitor in development for heparin-induced thrombocytopenia (HIT). The FDA and Cadrenal aligned on key elements of the protocol and Statistical Analysis Plan, including an optimized composite primary endpoint based on adjudicated new or worsening thromboembolic events in Serotonin Release Assay-positive patients through Day 14 or hospital discharge.

According to Cadrenal Therapeutics, the FDA also agreed to a placebo-controlled design with standard anticoagulation in both arms and to assess bleeding as a major safety endpoint using International Society on Thrombosis and Haemostasis criteria, providing greater clarity on the regulatory path for CAD-1005’s Phase 3 program.

Positive

• FDA alignment on Phase 3 primary endpoint, protocol, and Statistical Analysis Plan for CAD-1005
• Agreement on placebo-controlled Phase 3 design with standard anticoagulation in both CAD-1005 and control arms
• Inclusion of ISTH-standard bleeding assessment as a major safety endpoint in the Phase 3 trial

Negative

• None.

Argus Aug 31 session 77 alerts

+13.31% close to close 527.8x rel. volume Open Argus

Details

Market move: CVKD +13.31% in the Aug 31 session. Phase 3 regulatory alignment

+39.9% Peak Tracked

-12.3% Trough Tracked

$8.13M Market Cap

On Aug 31, the day this news came out, CVKD closed 13.31% above the previous close. Argus tracked a peak move of +39.9% during that session. Argus tracked a trough of -12.3% from its starting point during tracking. Our momentum scanner recorded 77 alerts for this stock that day. Relative volume reached 527.8x the daily average during tracking.

Data tracked by StockTitan Argus for the Aug 31 session.

Key Figures

Acute HIT diagnoses: approximately 50,000 patients annually Peak annual revenue opportunity: $2 billion FDA Type D meeting date: July 28, 2026 +2 more

Acute HIT diagnoses

approximately 50,000 patients annually

U.S. acute HIT population

Peak annual revenue opportunity

$2 billion

CAD-1005 projected opportunity

FDA Type D meeting date

July 28, 2026

FDA meeting held before announcement

Primary endpoint window

Day 14

Through Day 14 or hospital discharge

Safety population

at least one dose

Patients receiving study drug

Previous Clinical trial Reports

5 past events · Latest: Aug 03

Same Type 5 events

1. Aug 03

   Multi-indication strategy

   24h Move

   -2.5%

   CAD-1005 strategy expanded across HIT and CSA-AKI indications

2. Jul 13

   Phase 2 clinical data

   24h Move

   -16.3%

   Phase 2 HIT data showed greater than 25% thrombotic-event reduction

3. Jun 24

   Phase 2 presentation

   24h Move

   -2.6%

   CAD-1005 Phase 2 data selected for late-breaking oral presentation

4. Jun 03

   Partnering event

   24h Move

   -3.7%

   Company planned partnering meetings for Phase 3-ready CAD-1005

5. Apr 30

   Phase 3 registration path

   24h Move

   +19.3%

   FDA guidance supported advancing CAD-1005 into pivotal Phase 3

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

12-lipoxygenase (12-lox), heparin-induced thrombocytopenia (hit), statistical analysis plan (sap), serotonin release assay-positive (sra+), +2 more

6 terms

12-lipoxygenase (12-lox) medical

"first-in-class 12-lipoxygenase (12-LOX) inhibitor in development"

An enzyme that acts like a tiny factory machine inside cells, converting certain fatty molecules into signaling compounds that influence inflammation, blood clotting, and cell growth. For investors, 12-lipoxygenase (12-LOX) matters because drugs or diagnostics that block or measure its activity can alter disease processes and create commercial opportunities or risks for clinical-stage biotech programs focused on conditions such as inflammatory disorders, cardiovascular disease, and some cancers.

heparin-induced thrombocytopenia (hit) medical

"treat heparin-induced thrombocytopenia (HIT)"

Heparin-induced thrombocytopenia (HIT) is a serious immune reaction to the blood thinner heparin where the body mistakenly attacks platelets, causing their count to fall while paradoxically increasing the risk of dangerous clots; think of it as a friendly-fire response that both reduces clot-control cells and sparks unwanted clots. For investors, HIT matters because it can change demand for safer alternatives, trigger product warnings or sales restrictions, increase treatment costs, and raise regulatory and legal risks for drugmakers and hospitals.

statistical analysis plan (sap) technical

"protocol and Statistical Analysis Plan (SAP) for the Phase 3"

A statistical analysis plan (SAP) is a detailed blueprint that spells out, before results are seen, exactly how data from a study or trial will be checked, measured and compared. Investors care because a clear SAP reduces the chance of surprise or biased interpretation, making study results more reliable for judging a product’s safety, effectiveness or market potential—like reading a recipe before judging the cake it produces.

serotonin release assay-positive (sra+) medical

"proportion of Serotonin Release Assay-positive (SRA+) participants"

A serotonin release assay-positive (SRA+) result means a laboratory functional test found that a patient’s antibodies cause platelets to release serotonin when exposed to heparin, which is the hallmark laboratory evidence of heparin‑induced thrombocytopenia (HIT). It matters to investors because an SRA+ finding signals a verified, potentially serious drug‑safety issue or adverse event that can affect clinical trial outcomes, regulatory review, product labeling, liability, and market confidence—similar to a stress test showing a critical fault under normal operating conditions.

composite thromboembolic events (ctes) medical

"new or worsening composite thromboembolic events (CTEs)"

A composite thromboembolic events (CTEs) endpoint groups several types of blood-clot related problems — for example deep vein thrombosis, pulmonary embolism, stroke, heart attack, or other arterial or venous clots — into a single combined measure used in clinical studies. It matters to investors because trial results reported as a CTE rate summarize overall clot risk from a drug or device, like reporting a single score that captures several related outcomes and can drive regulatory, safety, and commercial decisions.

international society on thrombosis and haemostasis (isth) criteria medical

"using standard International Society on Thrombosis and Haemostasis (ISTH) criteria"

A set of standardized medical rules and scoring systems developed by the International Society on Thrombosis and Haemostasis (ISTH) to define and classify blood-clotting problems and bleeding events in clinical practice and research. Investors see these criteria in trial results and regulatory filings because they make safety and efficacy outcomes comparable across studies, like using the same ruler to measure and report how often and how severe clotting or bleeding occurs.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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. During the meeting, Cadrenal and the FDA aligned on key aspects of the protocol and Statistical Analysis Plan (SAP) for the Phase 3 registrational study of CAD-1005, the Company’s first-in-class 12-lipoxygenase (12-LOX) inhibitor in development to treat heparin-induced thrombocytopenia (HIT). HIT is a potentially life-threatening immune reaction to heparin, a widely used blood thinner, and can lead to dangerous blood clots.

In the U.S., heparin-induced thrombocytopenia (HIT) is a high-stakes emergency that affects approximately 50,000 patients with acute HIT each year. Current therapeutic options rely on standard anticoagulants to reduce thrombotic risk; however, they do not target the underlying immune mechanisms that drive this destructive cardiovascular cascade. CAD-1005 is a novel 12-LOX inhibitor designed to halt the core immune signaling pathway that drives platelet activation and vascular thrombosis. Developed as an essential add-on to standard anticoagulation, CAD-1005 targets a critical population and is projected to generate $2 billion in peak annual revenue.

During the Type D meeting, the FDA agreed on an optimized definition of worsening HIT for the primary endpoint, based on progression of thrombotic events through Day 14 of treatment or hospital discharge. To ensure high-quality, reliable endpoint evaluation across clinical sites, the worsening component of the primary endpoint will also include extension of an existing thrombus into a new vascular segment or bed, avoiding potential site-to-site variability from manual size measurements. The updated composite primary endpoint will measure the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events (CTEs) through Day 14 or hospital discharge. Additionally, the FDA agreed to use placebo control in the Phase 3 trial, with standard anticoagulation therapeutics for both the CAD-1005 and placebo control arms.

"We are very pleased with the collaborative, constructive feedback from the FDA during this Type D meeting," said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. "Securing agreement on the primary endpoint definition and the blinding protocols for our saline control provides greater clarity on the regulatory path forward for CAD-1005. We have incorporated the Agency's recommendations into our Phase 3 protocol and Statistical Analysis Plan, strengthening the design of a registration study intended to evaluate whether CAD-1005 can reduce dangerous thrombotic events that persist in patients with HIT despite current anticoagulant therapies."

The Phase 3 trial design will also assess bleeding as a major safety endpoint using standard International Society on Thrombosis and Haemostasis (ISTH) criteria. All safety analyses will be conducted in the safety population of patients who receive at least one dose of the study drug.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions. The Company’s pipeline includes CAD-1005, tecarfarin, and frunexian. CAD-1005 is a novel investigational therapeutic in development for the treatment of heparin-induced thrombocytopenia (HIT) and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). CAD-1005 is designed to selectively inhibit 12-lipoxygenase (12-LOX), an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that drive disease progression. CAD-1005 has an Orphan Drug Designation (“ODD”) from the U.S. Food and Drug Administration (“FDA”) for prophylaxis of thrombosis in patients with HIT, FDA Fast Track designation for the treatment and prevention of HIT, and an orphan designation from the European Medicines Agency for the treatment of platelet-activating factor 4 disorders. Second-generation 12-LOX oral therapeutics (CAD-2000) are also in development for chronic indications.

The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and atrial fibrillation, those with left ventricular assist devices, and potentially those with Kawasaki disease (KD), an acute, self-limited, febrile illness that primarily affects children under 5 years old and is the leading cause of acquired heart disease in developed countries. The Company recently submitted a request to the FDA for Rare Pediatric Disease Designation (RPDD) for tecarfarin for “Prevention of the Formation of Life-Threatening Blood Clots Inside Coronary Artery Aneurysms in Children with Kawasaki Disease”. Tecarfarin has also received Orphan Drug and Fast Track designations from the FDA.

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, without limitation, statements regarding the planned Phase 3 registration study of CAD-1005, the development of CAD-1005 to treat HIT; CAD-1005 potentially halting the core immune signaling pathway that drives platelet activation and vascular thrombosis; CAD-1005 being an essential add-on to standard anticoagulation; CAD-1005 unlocking a projected $2 billion in peak annual revenue; the worsening component of the primary endpoint of optimized definition of worsening HIT assessing extension of an existing thrombus into a new vascular segment or bed, avoiding potential site-to-site variability from manual size measurements; the updated composite primary endpoint measuring the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events (CTEs) through Day 14 or hospital discharge; the regulatory path forward for CAD-1005; the registration study evaluating whether CAD-1005 can reduce dangerous thrombotic events that continue to occur in patients with HIT despite current anticoagulant therapies; the Phase 3 trial design evaluating bleeding as a major safety endpoint using standard International Society on Thrombosis and Haemostasis (ISTH) criteria; all safety analyses in the Phase 3 trial being conducted in the true safety population of patients who receive at least one dose of the study drug; the Company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions; CAD-1005 being successfully developed to treat HIT and CSA-AKI; CAD-1005 selectively inhibiting 12-LOX, an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT; CAD-1005 being intended to be used alongside existing standards of care and being developed to address the underlying biological mechanisms that drive disease progression; second-generation 12-LOX oral therapeutics (CAD-2000) being developed for chronic indications; tecarfarin, a late-stage oral vitamin K antagonist, potentially preventing heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and atrial fibrillation, those with left ventricular assist devices, and potentially those with Kawasaki disease; and the FDA’s ultimate decision regarding the Company’s request for RPDD for tecarfarin for the prevention of life-threatening blood clots inside coronary artery aneurysms in children with Kawasaki Disease; Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to advance its programs to clinical trial readiness; the Company’s ability to enter into development, licensing, and commercialization transactions for CAD-1005, frunexian, and tecarfarin; the Company’s ability to secure nondilutive grants to advance its programs; and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, 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:

Lytham Partners, LLC

Robert Blum, Managing Partner

602-889-9700

CVKD@lythampartners.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did the FDA Type D meeting conclude for Cadrenal Therapeutics (CVKD) and CAD-1005 in August 2026?

The FDA Type D meeting provided alignment on key aspects of the Phase 3 registration study for CAD-1005. According to Cadrenal Therapeutics, the Agency agreed on the optimized primary endpoint, protocol, and Statistical Analysis Plan, clarifying the regulatory path for development in heparin-induced thrombocytopenia.

What is CAD-1005 being developed for in Cadrenal Therapeutics' (CVKD) Phase 3 trial?

CAD-1005 is being developed to treat heparin-induced thrombocytopenia (HIT), a serious immune reaction to heparin. According to Cadrenal Therapeutics, it is a first-in-class 12-LOX inhibitor designed as an add-on to standard anticoagulation to target immune-driven platelet activation and thrombosis.

What is the primary endpoint for Cadrenal Therapeutics' (CVKD) Phase 3 CAD-1005 HIT study?

The primary endpoint measures the proportion of Serotonin Release Assay-positive participants with adjudicated new or worsening composite thromboembolic events. According to Cadrenal Therapeutics, these events are assessed through Day 14 of treatment or hospital discharge, including extension of existing thrombi into new vascular segments.

How is the Phase 3 CAD-1005 trial for HIT designed regarding control and background therapy?

The Phase 3 CAD-1005 trial will use a placebo control, with both arms receiving standard anticoagulation therapies. According to Cadrenal Therapeutics, this design evaluates CAD-1005 as an add-on treatment while maintaining current anticoagulant care in all participants with heparin-induced thrombocytopenia.

What safety endpoints will be assessed in Cadrenal Therapeutics' (CVKD) Phase 3 trial of CAD-1005?

Bleeding will be a major safety endpoint in the Phase 3 CAD-1005 trial, using standard ISTH criteria. According to Cadrenal Therapeutics, all safety analyses will be conducted in patients who receive at least one dose of the study drug, providing structured safety evaluation.

How large is the potential market for CAD-1005 in heparin-induced thrombocytopenia for Cadrenal Therapeutics (CVKD)?

According to Cadrenal Therapeutics, approximately 50,000 patients in the U.S. experience acute HIT annually, representing a significant unmet need. The company projects CAD-1005, if successfully developed and approved, could reach an estimated $2 billion in peak annual revenue opportunity.