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Data updated: Jun 28, 2026
STEALTH BIOTHERAPS
Pharma Pharmaceuticals
STEALTH BIOTHERAPS is a pharmaceutical company with 1 FDA-approved products.
2025
Since
1
Drugs
-
Trials
1
New Drugs (2yr)
Modality:
1 Small Molecules
FDA Novel Drug Designations
(2025) 1 Novel 1 First-in-Class 1 Orphan 1 Accelerated 1 Priority Review 1 Fast Track
See 1 novel approval →
2025 FORZINITY (ELAMIPRETIDE HYDROCHLORIDE) First-in-Class · Orphan · Priority Review · Accelerated · Fast Track
STEALTH BIOTHERAPS's Key Drugs
STEALTH BIOTHERAPS's core commercial portfolio centers on FORZINITY — its most strategically important drugs approved in the last 15 years.
STEALTH BIOTHERAPS's Recent FDA Approvals
STEALTH BIOTHERAPS secured 1 new FDA approval for novel drugs (NDA/BLA) in the last two years.
STEALTH BIOTHERAPS's Therapeutic Areas
Disease areas where STEALTH BIOTHERAPS has approved drugs and an active pipeline. Weighted by commercial stage — approved drugs count most, then late-stage trials.
No indication data
STEALTH BIOTHERAPS Pipeline Snapshot
Active clinical trials for STEALTH BIOTHERAPS across all therapeutic areas, from ClinicalTrials.gov.
No active pipeline data available
Pro Expected Approvals & Milestones
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Revenue Insights
- • FORZINITY leads revenue
- • Drug-level revenue analysis
Trial Catalysts
- • Active trial monitoring
- • Phase 3 readout tracking
Patent Risk
- • Patent expiration timeline
- • Revenue at risk analysis
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Active (1)
Discontinued (0)
Company Info
- First Approval
- 2025-09-19
- Latest
- 2025-09-19
- Applications
- 1