BioCentury
ARTICLE | Company News

FDA extends review of Radius' osteoporosis candidate

March 10, 2017 7:48 PM UTC

Radius Health Inc. (NASDAQ:RDUS) slipped $2.26 to $40.85 on Friday after it said FDA delayed by three months the PDUFA date for abaloparatide-SC (BA058-SC), which it is reviewing to treat postmenopausal osteoporosis. The new PDUFA date is June 30 (see BioCentury Extra, June 1, 2016).

Radius said FDA is reviewing information the company submitted in response to the agency’s information requests. In its new letter to Radius, FDA did not request any further information, the company said...