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Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) is a pioneering biopharmaceutical company devoted to advancing the development of tecarfarin, an innovative anticoagulant (blood thinner). Tecarfarin is designed to reduce the risk of heart attacks, strokes, and fatalities caused by blood clots in patients with specific, rare cardiovascular conditions.
This novel therapy, currently in its late-stage of development, shows promise for patients suffering from conditions where traditional anticoagulants, such as warfarin and direct oral anticoagulants (DOACs) like Eliquis, fall short. Tecarfarin targets different metabolic pathways, which could provide more stable anticoagulation compared to warfarin, and is particularly significant for patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib).
Recent developments have highlighted tecarfarin's potential benefits:
- Cadrenal has secured orphan drug designation (ODD) from the FDA for tecarfarin's use in preventing thromboembolism and thrombosis in patients with mechanical circulatory support devices, such as left ventricular assist devices (LVADs). This designation offers incentives such as clinical research tax credits and seven years of market exclusivity post-approval.
- The company is exploring strategic partnerships and licensing agreements with The Sage Group, aiming to enhance clinical development and regulatory strategies globally.
- Tecarfarin has demonstrated efficacy in eleven human clinical trials involving over 1,000 individuals, showing generally good tolerance in both healthy subjects and those with chronic kidney disease.
- Cadrenal has also managed cash resources effectively, maintaining substantial financial flexibility, with significant cash reserves to continue advancing towards pivotal trials expected to commence in 2024.
As Cadrenal moves forward, its efforts are bolstered by the growing body of evidence supporting the need for a reliable Vitamin K antagonist (VKA) like tecarfarin. This is especially crucial for patients with LVADs and other conditions where DOACs are contraindicated or ineffective. For more information, please visit: www.cadrenal.com.
Cadrenal Therapeutics (Nasdaq: CVKD) has joined the Corporate Council of the Anticoagulation Forum (AC Forum), the largest professional organization of anticoagulation specialists. The company, which is developing tecarfarin, a new vitamin K antagonist for patients with implanted cardiac devices or rare cardiovascular conditions, will collaborate with AC Forum's 15,000 healthcare professional members to advance anticoagulation care quality and safety. This partnership aims to address unmet clinical needs, share research, and promote educational initiatives for improving patient outcomes on anticoagulants.
Cadrenal Therapeutics (Nasdaq: CVKD), a late-stage biopharmaceutical company developing tecarfarin, announced its participation in the Lytham Partners Fall 2024 Investor Conference. The virtual event will take place on Tuesday, October 1, 2024.
Key points:
- Cadrenal will deliver a webcast presentation at 2:00 pm ET
- The presentation will be accessible via the conference home page or a direct link
- Company management will participate in virtual one-on-one meetings with investors
- Investors can arrange meetings through Lytham Partners or by registering for the event
Tecarfarin is described as a new vitamin K antagonist designed to be a superior and safer chronic anticoagulant for warfarin-dependent patients with implanted cardiac devices or rare cardiovascular conditions.
Cadrenal Therapeutics (Nasdaq: CVKD) has announced an upcoming Type-B FDA meeting in September to discuss the clinical trial for tecarfarin in LVAD patients. Tecarfarin is a late-stage, next-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and rare cardiovascular conditions.
The company aims to address unmet needs in anticoagulation therapy, particularly for LVAD patients who face an increased risk of thromboembolic events. Tecarfarin has received orphan drug designation for thrombosis prevention in patients with ventricular assist devices, as well as orphan drug and fast-track designations for preventing systemic thromboembolism in patients with end-stage kidney disease and atrial fibrillation.
Cadrenal Therapeutics (Nasdaq: CVKD) highlighted a recently published manuscript in the Journal of Cardiac Failure, evaluating the relationship between time in therapeutic range (TTR) management quality and clinical outcomes for left ventricular assist device (LVAD) patients. The findings emphasize the need for improved anticoagulation therapy beyond warfarin to reduce gastrointestinal bleeding, a common complication in LVAD patients.
Key points:
- Tecarfarin, a novel vitamin K antagonist (VKA), may offer more stable and effective anticoagulation for LVAD patients
- A secondary analysis of the ARIES-HM3 trial showed a 47% reduction in bleeding risk for patients with a TTR above the median
- Lower TTRs were associated with threefold more sub-therapeutic INRs than supra-therapeutic INRs
- Cadrenal Therapeutics is developing tecarfarin as a late-stage, next-generation VKA oral and reversible anticoagulant
Cadrenal Therapeutics (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage anticoagulant, will participate in three upcoming investor conferences. The company's presentations will be available via webcast and include:
- Sidoti Micro-cap Virtual Conference on August 15, 2024, at 2:30 p.m. ET
- Summer 2024 Investor Summit Virtual Conference on August 20, 2024, at 3 p.m. ET
- Emerging Growth Conference on August 21, 2024, at 3:55 p.m. ET
Management will also participate in one-on-one institutional investor meetings at the Sidoti and Investor Summit conferences. Webcasts can be accessed through Cadrenal's investor relations website, with replays available after the events.
Cadrenal Therapeutics (Nasdaq: CVKD) provided its Q2 2024 corporate update. The biopharmaceutical company is developing tecarfarin, a next-gen oral anticoagulant targeting heart attacks, strokes, and blood clots in patients with implanted cardiac devices and rare cardiovascular conditions. Key highlights include:
- Collaboration with Abbott to develop tecarfarin for patients with LVADs.
- FDA Orphan Drug Designation for tecarfarin in April 2024.
- Presentation at the ISHLT meeting highlighting tecarfarin's potential over warfarin.
- Development of Phase 3 trial protocols for LVAD patients.
Q2 2024 financials showed $2.3M in operating expenses and $1.5M in cash used for operations. The company held $5M in cash as of June 30, 2024. Upcoming investor conferences include the Sidoti Micro Cap Conference on August 14-15, 2024, and H.C. Wainwright Global Investment Conference on September 9-11, 2024.
Cadrenal Therapeutics (Nasdaq: CVKD) has initiated discussions with Abbott (NYSE: ABT) regarding a planned pivotal study of tecarfarin in patients with recently implanted Left Ventricular Assist Devices (LVADs). Tecarfarin, a late-stage anticoagulant, received FDA Orphan Drug Designation in April 2024 for preventing blood clots and strokes in patients with implanted mechanical circulatory support devices. The collaboration focuses on improving anticoagulation treatment for HeartMate 3™ LVAD patients, currently the only LVAD available in the United States.
A recent analysis of the ARIES-HM3 study by Abbott highlighted that high-quality anticoagulation can further enhance outcomes with the HeartMate 3 LVAD. Prior clinical studies suggest that tecarfarin may provide improved anticoagulation quality, particularly in patients on multiple medications or with impaired renal function, both common in LVAD patients.
Cadrenal Therapeutics (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, will present at the Emerging Growth Conference on July 18, 2024, at 4:15 pm ET. Tecarfarin is a late-stage, new-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions.
The virtual conference provides a forum for institutional and retail investment community engagement. Investors can access the live webcast through the company's website or the provided link. An archived version will be available on EmergingGrowth.com and their YouTube channel. One-on-one investor meetings with management can be arranged through Emerging Growth Conference representatives or by contacting Cadrenal's investor relations team at CVKD@LythamPartners.com.
Cadrenal Therapeutics, trading under the ticker CVKD, will present at the Emerging Growth Conference on June 12, 2024. The company's management will deliver a webcasted presentation at 10:50 am ET, focusing on their lead product, tecarfarin, a new-generation Vitamin K Antagonist designed to prevent cardiovascular incidents. Attendees can join the live session or access an archived version later. Additionally, the company will hold one-on-one investor meetings post-conference. For meeting requests, attendees can contact the Emerging Growth Conference representative or email Cadrenal's investor relations team.
Cadrenal Therapeutics (Nasdaq: CVKD) has presented new data from the ARIES-HM3 trial at the ISHLT conference, showing the significant impact of anticoagulation quality in LVAD patients. The trial highlighted the deficiencies of warfarin and introduced tecarfarin, a novel VKA, as a potential replacement. Tecarfarin has received Orphan Drug Designation from the FDA for preventing thromboembolism in patients with mechanical circulatory support devices like LVADs.
The ARIES-HM3 data indicates a direct correlation between lower therapeutic range times (TTR) and higher bleeding events. The average patient experienced a 30% rate of serious bleeding even without aspirin in the regimen. Incremental improvements in TTR corresponded to significant reductions in bleeding rates, emphasizing the potential of tecarfarin to provide more stable anticoagulation compared to warfarin.
The data is under FDA review, and Cadrenal plans to pursue further pivotal trials to validate tecarfarin's effectiveness for LVAD patients.
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