RDUS - Radius stock rises as elacestrant gets FDA priority review to treat breast cancer subtype
- The U.S. Food and Drug Administration (FDA) granted priority review to Menarini's application seeking approval of elacestrant to treat patients with ER+/HER2- advanced or metastatic breast cancer.
- The FDA accepted the Italian pharmaceutical and diagnostic company's new drug application (NDA) and is expected to make a decision by Feb. 17, 2023. Under priority review, the FDA's goal is to take action within six months, compared to 10 months under standard review.
- The NDA was backed by data from a phase 3 trial called EMERALD, which was conducted by Radius Health ( NASDAQ: RDUS ). Menarini had obtained global licensing rights for elacestrant from Radius in July 2020.
- Menarini noted that it had filed for approval of the drug in the EU in July 2022.
- Elacestrant had received the FDA's fast track designation in 2018.
- RDUS +5.56% to $10.64 premarket Aug. 11
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Radius stock rises as elacestrant gets FDA priority review to treat breast cancer subtype