Company intelligence / Profile preview

Restem Group

Miami, Florida, United Statesrestem.com ↗

Ownership: Private
Employees: ~8
Development stage: Phase 2

Overview

Restem’s lead asset, Restem-L, has completed Phase 1 trials showing clinically meaningful efficacy and significant reduction in steroid use for idiopathic inflammatory myopathy. The program has received FDA Fast Track and Orphan Drug Designations. A pivotal Phase 2/3 trial (“IIMPACT”) is planned to start soon with interim data expected March 2026. Other pipeline assets are at earlier clinical or preclinical stages.

Therapeutic areas: OtherRheumatologyImmunology
Modalities: Stem cell therapyMesenchymal stem cell therapyCell therapyProtein (for secretome-based product)Activated natural killer cell therapy (NK cell therapy)
Industry: Biotech

Drug pipeline

2 assets

Restem-L

1 more asset in the full pipeline.

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