Radius Health (RDUS) Delay in U.S. 'Bad News', Maxim Group Says

Maxim Group analyst Jason McCarthy weighed in on Radius Health (NASDAQ: RDUS) after delays in the U.S. with the NDA filing pushed back while MAA submitted in Europe. The analyst sees this as a negative.

• While Radius announced that the company has submitted the MAA for abaloparatide-SC in Europe the company stated that the NDA submission in the U.S. has been pushed back to the end of 1Q16.
• Radius cited that the FDA requires 12 month stability data on abaloparatide-SC at the time of NDA submission. The data is not expected until December of 2015 and may not be analyzed until early 1Q16. European regulators only require 6-months of data, thus the acceptance of the MAA for review.
• Today's news is surprising as Radius had previously announced that the company had what it believed was the necessary data to support NDA filing, following completion of the abaloparatide extension study this past summer.
• Bottom line. We believe this is bad news for Radius, as the U.S. market for osteopotsis fractures holds the largest potential value for abaloparatide-SC. The European market is smaller and Radius is still seeking a partner. Delaying submission into 1Q16, or even longer, means that approval and launch of abaloparatide-SC are pushed back to at least mid-2017E. Timing is sensitive as Biosimilar Forteo is looming for 2018 which we believe limits the commercial opportunity for abaloparatide-SC.

For an analyst ratings summary and ratings history on Radius Health click here. For more ratings news on Radius Health click here.

Shares of Radius Health closed at $69.18 yesterday.

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