Stemline Therapeutics, Inc.
Stemline Therapeutics, part of the Menarini Group, is dedicated to developing and commercializing innovative oncology therapeutics. Their mission is to improve the lives of cancer patients through first-in-class treatments. They focus on therapies such as ELZONRIS® for BPDCN and ORSERDU™ for ER-positive breast cancer, with a broad pipeline of oncology drugs in various development stages. The company is headquartered in New York City and is committed to addressing unmet medical needs in cancer treatment.
Industries
Nr. of Employees
small (1-50)
Stemline Therapeutics, Inc.
Products
tagraxofusp (ELZONRIS)
A targeted biologic composed of a receptor-directed ligand fused to a truncated diphtheria toxin payload that binds CD123 (IL‑3 receptor α) to deliver a cytotoxic payload and induce apoptosis in target cells; approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN) and under clinical evaluation in other hematologic malignancies.
elacestrant (ORSERDU)
An oral selective estrogen receptor degrader (SERD) developed for ER-positive, HER2-negative advanced or metastatic breast cancer, including patients with ESR1 mutations; evaluated as monotherapy and in combinations across multiple Phase 2 and Phase 3 trials.
selinexor (NEXPOVIO)
An oral inhibitor of exportin-1 (XPO1) that modulates nuclear export of tumor suppressors and growth-regulatory proteins to induce cancer cell cycle arrest and apoptosis; approved for certain relapsed/refractory multiple myeloma indications and evaluated in combination regimens.
tagraxofusp (ELZONRIS)
A targeted biologic composed of a receptor-directed ligand fused to a truncated diphtheria toxin payload that binds CD123 (IL‑3 receptor α) to deliver a cytotoxic payload and induce apoptosis in target cells; approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN) and under clinical evaluation in other hematologic malignancies.
elacestrant (ORSERDU)
An oral selective estrogen receptor degrader (SERD) developed for ER-positive, HER2-negative advanced or metastatic breast cancer, including patients with ESR1 mutations; evaluated as monotherapy and in combinations across multiple Phase 2 and Phase 3 trials.
selinexor (NEXPOVIO)
An oral inhibitor of exportin-1 (XPO1) that modulates nuclear export of tumor suppressors and growth-regulatory proteins to induce cancer cell cycle arrest and apoptosis; approved for certain relapsed/refractory multiple myeloma indications and evaluated in combination regimens.
Services
Expanded Access Program evaluation and management
Case-by-case assessment and administration of pre-approval access to investigational oncology medicines, including physician-request intake, regulatory/ethics compliance, and supply assessment.
Expanded Access Program evaluation and management
Case-by-case assessment and administration of pre-approval access to investigational oncology medicines, including physician-request intake, regulatory/ethics compliance, and supply assessment.
Expertise Areas
- Oncology drug discovery and development
- Clinical trial management and operations
- Regulatory affairs and approvals (FDA/EMA designations)
- Immunotherapy and vaccine development
Key Technologies
- Ligand-toxin fusion biologics targeting cell-surface receptors (e.g., CD123)
- Antibody-drug conjugates (ADC)
- Selective estrogen receptor degraders (oral SERDs)
- Exportin-1 (XPO1) inhibitors