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Data updated: Jun 28, 2026

STEMLINE THERAP

Pharma
OncologyGastroenterology Execution: Fair

STEMLINE THERAP is a pharmaceutical company focused on Oncology, Gastroenterology. Key products include ORSERDU.

2023
Since
1
Drugs
-
Trials
0
New Drugs (2yr)
Modality:
1 Small Molecules

FDA Novel Drug Designations

(2023)
1 Novel 1 Priority Review 1 Fast Track
See 1 novel approval →
2023 ORSERDU (ELACESTRANT HYDROCHLORIDE) Priority Review · Fast Track

STEMLINE THERAP's Key Drugs

STEMLINE THERAP's core commercial portfolio centers on ORSERDU, spanning Oncology and Gastroenterology — its most strategically important drugs approved in the last 15 years.

STEMLINE THERAP's Recent FDA Approvals

New NDA/BLA approvals for STEMLINE THERAP over the last two years — novel drugs only, excluding generics and label supplements.

No recent approvals

STEMLINE THERAP's Therapeutic Areas

STEMLINE THERAP's approved drugs and pipeline span 2 therapeutic areas, led by Oncology and Gastroenterology, across 0 biologic and 1 small-molecule drug. Weighted by commercial stage — approved drugs count most, then late-stage trials.

Oncology 97%
1 drugs Phase 3: 2 Phase 2: 2 Phase 1: 13
Gastroenterology 3%
0 drugs Phase 1: 1

STEMLINE THERAP's Top Competitors

STEMLINE THERAP's closest competitors by therapeutic-area and drug-target overlap include Johnson & Johnson, Bristol-Myers Squibb, and Takeda. Ranked by overlap in therapeutic areas and drug targets across approved drugs and pipeline.

STEMLINE THERAP Pipeline Snapshot

STEMLINE THERAP has 18 active clinical programs from ClinicalTrials.gov — 2 Phase 3, 2 Phase 2 and 14 Phase 1.

2
Phase 3
2
Phase 2
14
Phase 1

Pro Intelligence Preview

Deep insights for investors and analysts

Revenue Insights

  • ORSERDU leads revenue
  • Drug-level revenue analysis

Trial Catalysts

  • Oncology pipeline focus
  • Phase 3 readout tracking

Patent Risk

  • Patent expiration timeline
  • Revenue at risk analysis

Compare Companies

  • Side-by-side pipeline analysis
  • Revenue & market share comparison

Execution Intelligence

  • Phase 3: 1/2 completed
  • Speed: 53 months avg
Unlock Full Intelligence

Revenue forecasts • Trial milestones • Patent risk modeling

How We Calculate These Metrics

Execution Quality Score

Measures trial completion rates weighted by phase importance. Phase 3 trials count 4x more than Phase 1 because late-stage completion is harder and more valuable.

What counts as "completed": A trial that reached its planned endpoint and reported results. Trials that were terminated early, withdrawn, or suspended are not counted as completed—these often indicate safety issues, lack of efficacy, or strategic pivots.

  • Excellent (80%+): Top-tier execution, most trials reach planned endpoints
  • Good (60-79%): Strong execution with occasional early terminations
  • Fair (40-59%): Average execution, notable rate of terminated/withdrawn trials
  • Needs Improvement (under 40%): High termination rates, execution challenges