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Immix Biopharma Receives FDA Regenerative Medicine Advanced Therapy Designation For NXC-201

Benzinga ·  Feb 10 14:36
  • FDA RMAT designation follows positive proof-of-concept U.S. clinical data from the NXC-201 NEXICART-2 clinical trial in relapsed/refractory AL Amyloidosis
  • RMAT designation potentially streamlines the path to market approval by allowing frequent interactions with FDA and routes to FDA Accelerated Approval and Priority Review
    • Enrollment in NEXICART-2 study accelerating; next update planned for H1 2025
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