Ponte Vedra-based Cadrenal Therapeutics receives second FDA orphan drug designation (Courtesy of the Jacksonville Business Journal) — Ponte Vedra Beach-based biopharmaceutical company Cadrenal Therapeutics announced Tuesday it has received a key designation from the U.S. Food and Drug Administration for tecarfarin.
Cadrenal [NASDAQ: CVKD] received an Orphan Drug Designation for its late-stage novel oral and reversible anticoagulant tecarfarin. The blood thinner designed to prevent heart attacks, strokes and deaths due to blood clots in patients with rare cardiovascular conditions was granted the status by the FDA for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device.
“This second orphan drug designation highlights the expanded need for tecarfarin where existing anticoagulation therapies are inadequate,” Cadrenal CEO and Founder Quang Pham said. “We are dedicated to advancing tecarfarin through clinical development options as swiftly as possible.”
All patients with mechanical circulatory support devices require chronic anticoagulation to prevent the formation of thrombus (clots) that can cause the device to fail or can result in a clot breaking off (embolizing), resulting in a stroke or other vascular catastrophe.
The drug was authorized under the FDA’s ODD program, which provides incentives to sponsor organizations for the development of innovative treatments for rare diseases that affect fewer than 200,000 people in the U.S.
Since its adoption in 1983, the Orphan Drug Act has helped those living with these conditions gain access to life-enhancing and life-saving therapies. ODD also provides certain benefits to drug developers, including assistance in the drug development process, tax credits for certain clinical research and a waiver of the New Drug Application user fee.
Most recently, Cadrenal raised $7.5 million in July through the issuance of 4.3 million shares at $1.75 a share as well as issuing unregistered warrants for 4.3 million additional shares at the same price. Cadrenal went public in February 2023.
Cadrenal was trading at $0.50 a share Tuesday morning as of press time.