LOS ANGELES - Immix Biopharma, Inc. (NASDAQ:IMMX), a clinical-stage biopharmaceutical company, has received orphan drug designation from the European Commission for its therapy NXC-201, aimed at treating multiple myeloma, a type of blood cancer. This regulatory milestone, announced today, grants the company certain benefits including a decade of market exclusivity upon authorization in the European Union (EU).
The orphan drug status is awarded to treatments for rare diseases that affect fewer than five in 10,000 people in the EU, and it is meant to incentivize the development of medical products for conditions with limited treatment options or where the new therapy offers significant benefits. NXC-201, which is also under investigation for the treatment of AL Amyloidosis and other autoimmune diseases, has been part of Immix Biopharma's ongoing Phase 1b/2 clinical trial named NEXICART-1 since February 2021.
Dr. Ilya Rachman, CEO of Immix Biopharma, highlighted the potential impact of NXC-201 on frail patients, who are a considerable segment of the relapsed/refractory multiple myeloma population and have an unmet medical need. The company's CFO, Gabriel Morris, also noted the favorable tolerability profile of NXC-201 and its potential as an attractive option for these patients.
According to a study by Davis et al. in 2023, currently available commercial CAR-T therapies have shown a median progression-free survival of 6.9 months in frail relapsed/refractory multiple myeloma patients. NXC-201 is designed to be a next-generation CAR-T therapy with a 'Single Day CRS' profile, potentially allowing patients a quicker recovery and discharge from medical facilities.
The orphan drug designation by the EC is based on a positive opinion from the European Medicines Agency's Committee for Orphan Medicinal Products. It offers Immix Biopharma regulatory support and financial incentives, including reduced fees for protocol assistance and marketing authorization applications.
Immix Biopharma has previously received orphan drug designation for NXC-201 by the U.S. Food and Drug Administration (FDA) for both AL Amyloidosis and multiple myeloma. The company's announcement today is based on a press release statement.
InvestingPro Insights
As Immix Biopharma, Inc. (NASDAQ:IMMX) secures orphan drug designation from the European Commission for its innovative therapy NXC-201, the company's financial health and market performance provide a broader context for investors. Immix Biopharma currently holds a market capitalization of approximately $56.22 million, which is reflective of investor sentiment and market recognition of the company's potential in the biopharmaceutical space.
The InvestingPro data shows a price-to-earnings (P/E) ratio of -3.24, with an adjusted P/E for the last twelve months as of Q4 2023 standing at -3.66. This negative P/E ratio indicates that the company has not been profitable over the past year, a fact that is in line with one of the InvestingPro Tips which states that analysts do not anticipate the company will be profitable this year. Moreover, the company's return on assets for the last twelve months as of Q4 2023 is -89.54%, suggesting that it has struggled to generate profit from its assets during this period.
InvestingPro Tips also reveal that Immix Biopharma is quickly burning through its cash reserves and suffers from weak gross profit margins. These financial challenges are important for investors to consider, especially in the context of the company's recent regulatory achievements. Despite these hurdles, the company holds more cash than debt, providing some financial flexibility as it continues to develop its therapies.
For investors seeking a deeper dive into Immix Biopharma's prospects, InvestingPro offers additional insights and metrics. There are 9 more InvestingPro Tips available that could further inform investment decisions, accessible at https://www.investing.com/pro/IMMX. Interested readers can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, enriching their investment strategy with valuable real-time data and analytics.
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