Menarini Group’s Stemline Therapeutics is paying $12 million upfront for licensing rights to Insilico Medicine’s breast cancer candidate in a deal potentially worth more than $500 million.
Stemline Therapeutics` Orserdu (elacestrant) Receives Approval in Europe
FLORENCE, Italy & NEW YORK--(BUSINESS WIRE)--The Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, announced today that the European Commission has approved ORSERDU® (elacestrant) as a monotherapy for the treatment of postmenopausal women, and men, with estrogen receptor (ER)?positive, HER2-negative, locally advanced or metastatic breast cancer (mBC) with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.
FLORENCE, Italy & NEW YORK--(BUSINESS WIRE)--The Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, today announced that Nippon Shinyaku Co., Ltd. (Nippon Shinyaku), Stemline’s development partner in Japan, received Orphan Drug Designation for tagraxofusp, from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the expected indication of blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Stemline's Biologic Elzonris (Tagraxofusp) Receives Approval in the U.S.
Stemline's Biologic Elzonris (Tagraxofusp) Receives Approval in the U.S.
FLORENCE, Italy & NEW YORK--(BUSINESS WIRE)--The Menarini Group (“Menarini”), a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics (“Stemline”), a wholly-owned subsidiary of the Menarini Group, today announced that EMA has validated the Marketing Authorization Application (MAA) for elacestrant, a selective estrogen receptor degrader (SERD), for patients with ER+/HER2- advanced or metastatic breast cancer. Validation of the application confirms the submission is complete and begins EMA’s centralized review procedure.
Menarini`s filing for oral SERD elacestrant gets FDA priority review
FLORENCE, Italy--(BUSINESS WIRE)--Menarini Group, a privately held Italian pharmaceutical and diagnostics company, today announced that is has successfully completed the acquisition of Stemline Therapeutics Inc., a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics (Nasdaq: STML), for an aggregate cash consideration up to $677 million on a fully diluted basis.