FLORENCE, Italy and NEW YORK, NY, Aug. 11, 2022 /PRNewswire/ — The Menarini Group (“Menarini”), a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics (“Stemline”), a wholly-owned subsidiary of Menarini Group, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for elacestrant, an investigational selective estrogen receptor degrader (SERD), for patients with ER+/HER2- advanced or metastatic breast cancer. The FDA has granted the application Priority Review and assigned a PDUFA date of February 17, 2023.