Immix Biopharma (NASDAQ:IMMX) saw its stock rise 5% on Wednesday following an announcement that the company’s investigational therapy NXC-201 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. The designation applies to the use of NXC-201 in treating relapsed or refractory AL Amyloidosis.
The FDA's Breakthrough Therapy program is intended to accelerate the development and review of treatments that appear to offer substantial improvement over available therapies for serious conditions. Immix said the agency’s decision was informed by positive interim clinical results from the company’s NEXICART-2 Phase 2 trial. Those interim findings were presented at the American Society of Hematology annual meeting in December 2025.
According to Immix, NXC-201 is the only therapy currently in active development for relapsed or refractory AL Amyloidosis to have received this particular FDA designation. The company highlighted the absence of approved treatment options for patients who have relapsed or become resistant to initial therapies for the disease.
"We are grateful to FDA for recognizing NXC-201 as the only granted FDA Breakthrough Designation for a therapy in active development in relapsed/refractory AL Amyloidosis, where no approved therapies exist for patients today," said Ilya Rachman, CEO of Immix Biopharma.
Immix said it plans to complete enrollment in the NEXICART-2 trial, with final data anticipated later this year. Following the availability of those data, the company intends to submit a planned Biologics License Application to the FDA.
The company statement and the subsequent market reaction underline investor attention on regulatory milestones in the biotech sector. While the Breakthrough Therapy Designation is intended to speed development and review, Immix’s timeline remains linked to completion of trial enrollment and the generation of final trial results before the next regulatory step.
This development centers on a rare disease category and has implications primarily for the biotechnology and healthcare sectors, as well as for equity investors watching small-cap drug developers and regulatory event-driven catalysts.