Shares of Regado Biosciences, Inc. (RGDO) soared 38.1% and also touched a 52-week high after the U.S. Food and Drug Administration (FDA) granted a fast track designation to the company’s lead candidate, REG1 (consisting of pegnivacogin and anivamersen). The candidate is being developed as an anticoagulant for patients suffering from coronary artery disease during percutaneous coronary interventions (PCI).
We note that the FDA grants fast track designation to those candidates that are being developed for the treatment of serious conditions with unmet medical need, with the overall goal of getting new drugs to patients faster.
Regado is currently enrolling patients in the phase III REGULATE-PCI study on REG1 in those suffering from coronary artery disease undergoing PCI. Regado intends to complete enrollment of the first 1000 patients for this study in the second quarter of 2014. If the phase III study succeeds, Regado will be filing regulatory applications in early 2016.
We are encouraged by the U.S. regulatory authority granting fast track designation to REG1. We expect investor focus to remain on REG1 going forward. Meanwhile, Regado also has REG2 in its pipeline. Last month, the FDA accepted the company's investigational new drug application for REG2.
Regado is evaluating REG2 in a wide range of acute and sub-acute care cardiovascular indications such as venous thromboembolism prophylaxis in patients undergoing abdominal surgery. Regado is also evaluating REG2 for treating transcatheter aortic valve implantation patients and for bridging patients who are unable to take oral anticoagulants. The company also intends to conduct further clinical testing in sub-acute venous thrombosis indications.
Regado currently carries a Zacks Rank #2 (Buy). Right now, investors may also consider Alexion Pharmaceuticals, Inc. (ALXN), Alkermes (ALKS) and Actelion Ltd. (ALIOF). While Alexion and Alkermes hold a Zacks Rank #1 (Strong Buy), Actelion carries a Zacks Rank #2.
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