Immix Biopharma — NXC-201 receives FDA RMAT designation

Immix Biopharma has been granted a Regenerative Medicine Advanced Therapy (RMAT) designation by the US Food and Drug Administration (FDA) for the company’s novel sterically optimized CAR-T treatment, NXC-201, which is being developed as a potential treatment for relapsed/refractory amyloid light chain amyloidosis (r/r ALA). The RMAT designation offers several operational and regulatory benefits, which could streamline the clinical development and subsequent approval process for NXC-201, for example by enabling frequent interactions with the FDA. We note that NXC-201 has already been awarded orphan drug designation by the FDA and the European Medicines Agency (EMA), reflecting a robust position in what could be key markets for the therapy. NXC-201 is currently being evaluated in the US-based NEXICART-2 trial, and the next update (expected in H125) may represent a near-term catalyst for Immix, in our view.