PONTE VEDRA, Fla. - Cadrenal Therapeutics, Inc. (NASDAQ:CVKD), a biopharmaceutical company, announced today the FDA has awarded Orphan Drug Designation (ODD) to its anticoagulant tecarfarin. This designation is specific to its use in preventing blood clots in patients with rare cardiovascular conditions who have mechanical circulatory support devices implanted.
The FDA's ODD program aims to encourage the development of treatments for rare diseases, defined as those affecting fewer than 200,000 individuals in the U.S. The status potentially grants tecarfarin seven years of market exclusivity upon approval and offers benefits such as development assistance, clinical research tax credits, and exemption from the New Drug Application fee.
Tecarfarin is designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with ventricular assist devices (VADs), including left ventricular assist devices (LVADs) and right ventricular assist devices (RVADs). These patients require ongoing anticoagulation therapy to prevent clot formation, which can lead to device failure or serious complications like strokes.
Current direct oral anticoagulants (DOACs) like Eliquis are not indicated for VAD patients, and warfarin, the available Vitamin K Antagonist (VKA), demonstrates a therapeutic range maintenance of only 56%, which is associated with increased risks.
Cadrenal's tecarfarin is in late-stage development and has previously received orphan drug and fast-track designations for other indications. The company reports that tecarfarin has been well-tolerated in clinical trials involving over 1,000 individuals.
The FDA's recognition of tecarfarin for this specific use underscores the need for improved anticoagulation options for patients with mechanical heart support devices. As Quang Pham, CEO of Cadrenal Therapeutics, stated, this second orphan drug designation emphasizes the necessity for tecarfarin where current therapies fall short. The company is committed to expediting the clinical development of tecarfarin.
This announcement is based on a press release statement from Cadrenal Therapeutics. The company's focus remains on addressing unmet medical needs in anticoagulation therapy, particularly for patients with thrombotic antiphospholipid syndrome (APS) and those with VADs.
InvestingPro Insights
Following the recent announcement by Cadrenal Therapeutics (NASDAQ:CVKD) regarding the FDA's Orphan Drug Designation for tecarfarin, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, Cadrenal Therapeutics currently holds a market capitalization of 8.16 million USD and has a negative P/E ratio of -0.96, reflecting investor concerns about profitability in the near term. This is further supported by the company's EBITDA, which stands at -7.63 million USD for the last twelve months as of Q4 2023, indicating significant operational losses.
Despite the promising clinical prospects of tecarfarin, InvestingPro Tips suggest that Cadrenal Therapeutics is quickly burning through cash and suffers from weak gross profit margins. Analysts do not anticipate the company will be profitable this year, which aligns with a 1-month price total return of -23.84%, demonstrating the stock's poor performance over the recent period. It is also important to note that the company does not pay a dividend to shareholders, which may be a factor for income-focused investors to consider.
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