Stemline Therapeutics, Inc.

Biotech

Pipeline Programs↗

Distinct drugs in development (Preclinical–Phase 3)

Indications↗

Distinct diseases across all programs

Clinical Trials↗

All sponsored trials (all statuses)

Orange Book Patents

Across 1 drug with upcoming expirations

Pipeline

Pipeline Snapshot

By Phase

2 drugs in development

Phase 12

By Therapeutic Area

top 1

Oncology

2100%

R&D Momentum

35/100

Pipeline Velocity

6/100

Trial Completion Rate

75/100

Pipeline Concentration

100/100

Pipeline Freshness

77/100

Activity

Recent Activity

Last 14 days

Jul 9, 2026

Recruiting

Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

Jul 7, 2026

Recruiting

A Phase 1, First-in-Human Study of MEN2501, a KIF18A Inhibitor, as Monotherapy in Participants With Platinum-Resistant Ovarian Cancer

Earlier

Jan 14, 2025TrialA Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

Oct 25, 2024TrialA First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer

May 19, 2023TrialELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study

Mar 13, 2023TrialA PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function

Jan 27, 2023FDAOrserdu — ORSERDU

Jan 24, 2023TrialOpen-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

4 more events

Aug 31, 2022TrialStudy of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer

Mar 19, 2021TrialStudy of the PI3K Inhibitor SL-901 in Patients With Advanced Solid Tumors

May 10, 2019TrialPhase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

Dec 21, 2018FDAELZONRIS — ELZONRIS

Details

Company Info

Company Overview

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Mkt Cap

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Revenue

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Cash

Patent Expirations

5 patent groups across drugs · Source: FDA Orange Book

DrugExpires

OrserduAug 18, 2026 Orserdu2 patentsOct 10, 2034 OrserduOct 3, 2036 OrserduFeb 28, 2037 Orserdu2 patentsJan 5, 2038

Pipeline

Drug Pipeline

Indication

Preclinical

Phase 1

Phase 2

Phase 3

Approved

Oncology

Platinum-Resistant Ovarian Cancer

MEN2501

Oncology

Breast Cancer

MEN2312Phase 1

Ovarian Cancer

MEN2501Phase 1

Platinum-Resistant Ovarian Cancer

MEN2501Phase 1

Regulatory

Regulatory Timeline

20181 event

FDADec 21

ELZONRIS — ELZONRIS

Application BLA761116 (BLA)

20231 event

FDAJan 27

Orserdu — ORSERDU

Application NDA217639 (NDA)

Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)