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New Alert: Cadrenal Therapeutics, Inc. (Nasdaq: CVKD)
CVKD is our brand new NASDAQ alert.
CVKD could be positioning for a big rally higher.
It had a very similar chart setup in August after which it rallied +44% in just 2 weeks!
Plus, the RSI is again at the same level it was last time it went on that massive rally.
CVKD is a NASDAQ listed “biopharmaceutical company”.
CVKD is “developing transformative therapeutics to overcome the gaps in anticoagulation therapy”.
Earlier this year, CVKD “was added to multiple Russell indexes, including the Russell 3000E and Russell Microcap families”.
These indexes are widely tracked by institutional investors and index funds.
This is why any short-term market volatility could present a big opportunity with so many investors watching it.
The company’s “lead investigational product is tecarfarin, a novel oral Vitamin K antagonist anticoagulant that is designed to address unmet needs in anticoagulation therapy”.
Tecarfarin is a “reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation”.
The problem:
“There is a lack of approved anticoagulation therapies for patients with implanted cardiac devices such as Left Ventricular Assist Devices (LVADs), mechanical heart valves (MHVs) or rare cardiovascular conditions requiring chronic anticoagulation, such as end-stage kidney disease (ESKD) with atrial fibrillation (AFib).”
“The vitamin K antagonist (VKA) warfarin, commonly prescribed for patients with these conditions, is well known for its serious side effects and cumbersome treatment management.”
“Patients with implanted cardiac devices or rare cardiovascular conditions have been excluded from the late-stage trials for all direct oral anticoagulants, or DOACs (Eliquis-class drugs); subsequent trials have shown negative or inconclusive data for these patients.”
Here is the company’s solution to this problem:
With tecarfarin, CVKD aims to “reduce the clinical complexities of managing Vitamin K antagonists, particularly where direct-acting oral anticoagulants (DOACs) remain inadequate or unproven”.
Tecarfarin is “metabolized via a different pathway than warfarin and data shows that its efficacy is unaffected by common drug-drug interactions or kidney impairment, which are common in these patients”.
Furthermore:
“Phase 2/3 clinical trials show that tecarfarin may offer more stability and time in therapeutic range that inversely correlates with major events.”
“Extensive data shows the potential of tecarfarin to be superior to warfarin, resulting in fewer adverse events such as strokes, heart attacks, bleeds and deaths for patients with implanted cardiac devices such as LVADs, MHVs or rare cardiovascular conditions such as ESKD with Afib.”
Importantly, “Tecarfarin received Orphan Drug Designation (ODD) and fast-track designation for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation (ESKD+AFib)”.
CVKD also “received ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs)”.
CVKD has announced multiple accomplishments recently.
In August, the company announced:
“Cadrenal Therapeutics Announces Clinical Trial Initiation Plans for Tecarfarin in Patients with End-Stage Kidney Disease (ESKD) Transitioning to Dialysis”
“Currently, there is limited evidence supporting the use of anticoagulant therapy in dialysis patients. Dialysis patients are often excluded from clinical trials due to their high underlying risk profile, and studies of direct oral anticoagulants (DOACs) in this patient population have not provided clear answers. Furthermore, a recent Phase 2 trial of chronic hemodialysis patients sponsored by a global company showed no benefit from the new class of Factor XI inhibitors in maintaining vascular access graft patency. To date, no prospective studies have examined the benefit of oral anticoagulation in preventing thrombotic events at the time of dialysis initiation.”
Here are some comments from this press release:
"Initiating dialysis carries substantial excess risk of cardiovascular events and mortality, and to date, this risk has not been sufficiently addressed. Tecarfarin, a next-generation Vitamin K antagonist with a unique metabolism pathway that is not significantly affected by kidney impairment, has potential promise in this area of unmet need," said Wolfgang Winkelmayer, Professor of Medicine and Chief of Nephrology at Baylor College of Medicine in Houston, Texas.
In addition, the company also announced:
“Cadrenal Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update”
Here are the highlights from this press release:
“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”
Here are some of the company’s comments from this press release:
"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."
In addition:
"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."
Most recently, the company announced:
“Cadrenal Therapeutics Enhances Anticoagulation Pipeline Through Acquisition of eXIthera’s Portfolio of Factor XIa Inhibitors”
Here are the highlights from this press release:
“Acquisition significantly enhances the Company’s pipeline by adding novel assets in acute and chronic anticoagulation settings”
“Company is strategically poised to deliver differentiated therapeutics across the spectrum of cardiovascular thrombotic risk”
As the company further notes:
“eXIthera’s lead asset, frunexian, is a first-in-class, Phase 2-ready intravenous (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. The acquisition also includes EP-7327, an oral Factor XIa inhibitor, for the prevention and treatment of major thrombotic conditions.”
Importantly:
“With this acquisition, Cadrenal is the only company in the world developing a novel vitamin K antagonist (tecarfarin) and Factor XIa inhibitors, a promising new class of anticoagulants,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics.
“These newly acquired assets will expand Cadrenal’s capabilities in an effort to address even more critical gaps in current antithrombotic treatment, especially for patients for whom current therapies are unreliable or carry excessive bleeding risk.”
And…
“Unlike current anticoagulants on the market, which increase the risk of bleeding by broadly impairing coagulation, eXIthera’s compounds are mechanism-based inhibitors of Factor XIa, offering high potency, selectivity, and tunable pharmacokinetics. Factor XIa inhibition is one of the most active and exciting areas of current thrombosis research.”
Here are some of the company’s comments from this press release:
“This acquisition reinforces Cadrenal’s long-term vision of becoming a category leader in anticoagulation,” added Pham. “With tecarfarin planning a trial in patients with end-stage kidney disease transitioning to dialysis, our plans for LVAD patients, and the current addition of frunexian and EP-7327, we believe that Cadrenal is strategically positioned to deliver differentiated therapeutics across the entire spectrum of patients with cardiovascular thrombotic risk.”
CVKD could be positioned to rally higher.
Make sure to do your own due diligence.
Happy Trading!
SmallCapStocks Team
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