Immix Biopharma shares surge 11.78% premarket after FDA grants NXC-201 Breakthrough Therapy Designation based on positive NEXICART-2 Phase 2 results.

Immix Biopharma surged 11.78% in premarket trading following the U.S. FDA’s Breakthrough Therapy Designation for its lead candidate, NXC-201, in relapsed/refractory AL Amyloidosis. The designation, granted based on positive interim Phase 2 results from the NEXICART-2 trial presented at the 2025 ASH annual meeting, underscores the therapy’s potential to address a critical unmet medical need. The company highlighted NXC-201 as the only therapy in active development for this indication to receive such a designation, with final trial data expected this year and a planned BLA submission. The milestone, coupled with the disease’s growing prevalence and a $6 billion projected market by 2025, likely fueled investor optimism about accelerated regulatory pathways and commercial potential.