Radius Health, Inc. (RDUS) Falls on Delay in US Drug Application
Shares of Cambridge, Massachusetts, based Radius Health, Inc. (RDUS) fell on Tuesday, against the backrop of a mixed day in stocks overall. Radius Health's stock was down 11.09%, falling $7.67 per share, to close at $61.51, on volume of 2,540,166 shares. The company's anti-osteoporosus drug has been filed for approval in Europe, but will be delayed in applying for approval in the US, causing the stock to fall.
Radius Health submitted a Marketing Authorization Application (MAA) for it's drug therapy, abaloparatide, for approval in the European Union. The company also believes that it will have the data necessary to support an application for approval in the US, but not until the end of the first quarter of 2016. As a result, US approval of the drug will be delayed beyond earlier projections. Investors reacted by selling off the stock.
Abaloparatide is an investigational, once-daily subcutaneous injection intended for the treatment of postmenopausal osteoporosis in women. Trials so far include an 18 month study involving 2,463 women in which significant improvement was achieved in patients experiencing fractures, compared to those given a placebo. If approved by the EU, it will be the first new bone anabolic in Europe since 2003. The company also plans to begin clinical evaluation for an optimized abaloparatide transdermal patch by the end of this year.
The US Federal Drug Administration (FDA) requires that a 12-month stability data be submitted at the time of a new drug application (NDA). The company expects that the 12-month time frame for the abaloparatide stability will be achieved sometime in December 2015. The company expects to initiate data analysis in January 2016, and changed the US drug application to the end of the first quarter of 2016. As additional stability data become available they will be submitted in support of the targeted 3-year shelf life for the commercial product following receipt of regulatory approval.
"Today marks a major milestone for Radius Health with the submission of our MAA in Europe for the investigational drug abaloparatide-SC for the potential treatment of postmenopausal osteoporosis." said Robert E. Ward, President and CEO of Radius Health. "This is the first step towards achieving our goal to make abaloparatide available to patients around the world who are suffering from the burden of osteoporosis."
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