Regado Biosciences, Inc.
) 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).
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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
Regado currently carries a Zacks Rank #2 (Buy). Right now,
investors may also consider
Alexion Pharmaceuticals, Inc.
). While Alexion and Alkermes hold a Zacks Rank #1 (Strong Buy),
Actelion carries a Zacks Rank #2.