RDUS - Menarini Group Radius Health seek FDA approval for breast cancer treatment elacestrant

Italian pharma giant Menarini Group and Radius Health (NASDAQ:RDUS) on Wednesday said they had submitted a new drug application to the U.S. FDA for their drug elacestrant to treat breast cancer. RDUS' elacestrant, which has been out-licensed to Menarini, is intended for the potential treatment of ER+/HER2- advanced or metastatic breast cancer patients. The companies said that they had requested the FDA for a priority review, a process created by the regulator to speed up the approval of treatments for serious conditions that can be potentially much better than standard treatments. If the priority review is granted, the companies believe that the FDA would conduct an eight-month review, incorporating a six-month priority designation review. The new drug application submission is based on positive phase 3 data from the EMERALD study that was previously announced in Oct. 2021. RDUS stock earlier closed -3.1% at $8.91.

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Menarini Group, Radius Health seek FDA approval for breast cancer treatment elacestrant