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NXC-201 (formerly HBI0101)

Relapsed/Refractory AL Amyloidosis

Phase 2Active; FDA Breakthrough Therapy Designation granted Jan 2026NCT06097832, NCT04720313

Key Facts

Indication
Relapsed/Refractory AL Amyloidosis
Phase
Phase 2
Status
Active; FDA Breakthrough Therapy Designation granted Jan 2026
Company

About Immix Biopharma

Immix Biopharma is a public company (NASDAQ: IMMX) focused on developing transformative cell therapies for serious diseases, starting with AL Amyloidosis. Its core innovation is the N-GENIUS platform, which produces sterically-optimized CAR-Ts designed to overcome neurotoxicity—the major barrier to CAR-T adoption. The company has achieved key milestones including FDA Breakthrough Therapy Designation for NXC-201, strong Phase 1b/2a clinical results (92% ORR), and recently closed a $100 million underwritten offering to advance its pipeline.

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