FLORENCE, ITALY AND NEW YORK

The Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, along with clinical stage generative artificial intelligence (AI)-driven biotechnology company Insilico Medicine (“Insilico”), today announced…

The Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, presented results from phase 1b/2 ELEVATE and ELECTRA clinical studies evaluating ORSERDU® (elacestrant) in combination with other treatments. Both the…

The Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, today presented results from a new post hoc analysis of the pivotal EMERALD clinical study that demonstrated a clinically meaningful improvement in…

– Data spans eleven presentations across both solid tumors and hematologic malignancies, providing added understanding of the potential benefit these therapies bring to patients – ORSERDU data reinforce its key role in the treatment of ER+, HER2- advanced or metastatic breast cancer (mBC) tumors that harbor ESR1 mutations, while showing initial data from combination trials – ELZONRIS presentation […]

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…

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…

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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the approval of ORSERDU® (elacestrant) monotherapy, indicated for […]

The Menarini Group (“Menarini”), a leading Italian pharmaceutical and diagnostics company, and Stemline Therapeutics (“Stemline”), a wholly-owned subsidiary of the Menarini Group, today announced results from a new analysis of the pivotal EMERALD clinical study that suggest that oral single-agent elacestrant may be effective in ER+, HER2- advanced or metastatic breast cancer patients with Non-Detected ESR1-mut […]

The Menarini Group (“Menarini”), a leading Italian pharmaceutical and diagnostics company, and Stemline Therapeutics (“Stemline”), a wholly-owned subsidiary of the Menarini Group, announced today that they will present new data related to elacestrant in upcoming congresses. Elacestrant has been approved by the FDA for treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, […]

The Menarini Group (“Menarini”), a leading Italian pharmaceutical and diagnostics company, announced today that the U.S. Food and Drug Administration (FDA) has approved ORSERDU for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline Therapeutics (“Stemline”), a […]