Regado Biosciences, Inc. , a clinical stage biopharmaceutical company, recently received positive news when the U.S. Food and Drug Administration (FDA) accepted the company's investigational new drug (IND) application for REG2.
Regado is developing REG2, an extended release formulation of pegnivacogin, which is the prime component in company’s lead candidate REG1.
Regado is evaluating REG2 for potential uses 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 being evaluated as treatment for transcatheter aortic valve implantation (TAVI) patients and for bridging patients who are unable to take oral anticoagulants.
We note that Regado had previously completed a single escalating-dose phase I clinical trial on REG2. The company intends to conduct additional clinical testing in sub-acute venous thrombosis indications in future.
Meanwhile, Regado is evaluating lead candidate REG1 (consists of pegnivacogin, and anivamersen) as an anticoagulant for patients suffering from a variety of cardiovascular conditions and undergoing percutaneous coronary intervention (PCI).
PCI is a mechanical process to open or widen obstructed coronary arteries.
Regado’s prime focus is development of REG1 (in a phase III trial, REGULATE-PCI). The acceptance of IND for REG2 is a boost for the company’s pipeline. We expect investor focus to remain on REG1.
Regado currently carries a Zacks Rank #2 (Buy). Right now, investors may also consider Endocyte Inc. (ECYT - Snapshot Report), Actelion Ltd. (ALIOF - Snapshot Report) and Biogen Idec Inc. (BIIB - Analyst Report). All three carry a Zacks Rank #1 (Strong Buy).