Immix Biopharma - NXC-201 gains Orphan Drug designation in MM

Immix has announced that the FDA has granted orphan drug designation (ODD) to CAR-T asset NXC-201 for multiple myeloma (MM). The benefits of ODD include seven years of US market exclusivity post approval, tax credits for qualified clinical trials and exemption from the Prescription Drug User Fee. ODD is issued to drugs/biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases/conditions that affect fewer than 200k people in the US. With NXC-201, Immix aims to differentiate against currently approved CAR-T therapies that are often associated with neurotoxicity and high-grade cytokine release syndrome (CRS). NXC-201 data appears to provide a competitive safety profile with no serious adverse events reported to date, positioning it as potentially the first outpatient CAR-T therapy. We believe the ODD marks a key milestone and believe that the next readout (expected in September 2023) from the ongoing NEXICART-1 trial could be an important catalyst for the company.