Boston, MA 03/12/2014 (wallstreetpr) – Regado Biosciences Inc (NASDAQ:RGDO) needs to bring a new drug to the market to unlock more revenue. The company has already secured important support to this effect following the Fast Track Designation that the U.S. Food and Drug Administration has given its lead drug candidate REG1.
This means that the drug is considered to have potential solution for serious conditions whose treatment needs remain unmet. Moreover, the FDA fast track designation offers REG1 review priority.
Shares of Regado Biosciences Inc (NASDAQ:RGDO) scaled up more than 38 percent to touch a 52-week high at $11.54, before falling 3.36 percent to $10.92 Tuesday. The day was characterized with large volume changing hands and investors willing to sell or buy the stock in the price range of $10.51 and $11.54.
Next After FDA fast track designation
REG1 is being developed to treat patients with coronary artery disease. The drug is considered to bear potential solution in an area with unmet medical needs, thus the fast track designation earned from FDA. It is hoped that this new designation will enable Regado Biosciences Inc (NASDAQ:RGDO) to bring the drug to the market faster. Currently the drug is set to undergo Phase III study whereby the first 1,000 patients are expected to be enrolled for the study by second quarter of 2014.
And if all goes well, Regado Biosciences Inc (NASDAQ:RGDO) should be able to file regulatory application for the drug early 2016.
Looking at the need for effective treatment of coronary artery disease, REG1 is likely to be met with overwhelming sales when it eventual hit the stores.
Backup opportunities
If REG1 goes through and makes debut in the market in the shortest time possible, it will not be the only cash cow for Regado Biosciences Inc (NASDAQ:RGDO) to peg its hopes in. The company has an attractive pipeline that should backup REG1 in the future. The company has already secured new drug investigation application approval for REG2 from FDA. This drug is being tried for treatment of a range of acute cardiovascular conditions.
