Immix Biopharma - Updates galore: NXC-201 ODD (EU) and raise
Immix Biopharma has released back-to-back updates, including EU orphan drug designation (ODD) for its lead CAR-T asset NXC-201, addressing amyloid light chain amyloidosis (ALA), and pricing of its $15m equity raise. This follows on the heels of the ODD grant for its lead asset by the FDA for two indications, ALA and multiple myeloma (MM), in H223. The EU ODD includes up to 10 years of EU market exclusivity (post-approval), reduced regulatory fees and access to the EU centralized authorization procedure. Achieving ODD in ALA in the EU is a key step forward for the clinical development of NXC-201. We believe the next readout from the ongoing NEXICART-1 trial and dosing of patients at US trial sites (NEXICART-2) across H124 will be the key upcoming catalysts for the company.
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