Last close As at 05/08/2026
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▲ 0.21 (2.25%)
Market capitalisation
USD520m
Research: Healthcare
Immix has announced that the FDA has granted orphan drug designation (ODD) to CAR-T asset NXC-201 for amyloid light chain amyloidosis (ALA). This occurred approximately a month after the announced ODD for multiple myeloma (MM), the other indication that Immix is pursuing with NXC-201. 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 (c $3m for a new drug). 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. Achieving ODD in both MM and ALA marks an important development for the progress of NXC-201, which has shown encouraging signs on both the clinical and regulatory fronts. We believe that the next readout (expected in September 2023) from the ongoing NEXICART-1 trial could be a significant catalyst for the company.
Written by
Immix Biopharma |
NXC-201 gains orphan drug designation in ALA |
Regulatory update |
Pharma and biotech |
22 September 2023 |
Share price performance
Business description
Analysts
Immix Biopharma is a research client of Edison Investment Research Limited |
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Immix has announced that the FDA has granted orphan drug designation (ODD) to CAR-T asset NXC-201 for amyloid light chain amyloidosis (ALA). This occurred approximately a month after the announced ODD for multiple myeloma (MM), the other indication that Immix is pursuing with NXC-201. 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 (c $3m for a new drug). 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. Achieving ODD in both MM and ALA marks an important development for the progress of NXC-201, which has shown encouraging signs on both the clinical and regulatory fronts. We believe that the next readout (expected in September 2023) from the ongoing NEXICART-1 trial could be a significant catalyst for the company.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
0.0 |
(1.31) |
(0.36) |
0.0 |
N/A |
N/A |
12/22 |
0.0 |
(7.70) |
(0.55) |
0.0 |
N/A |
N/A |
12/23e |
0.0 |
(12.26) |
(0.84) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(15.83) |
(0.97) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.
Immix has announced that the US FDA has granted ODD to NXC-201 as a potential treatment for ALA. NXC-201 now has ODD for both ALA and MM. The ODD qualifies NXC-201 for a minimum of seven years of US market exclusivity, provided it obtains FDA approval. According to EvaluatePharma, the amyloidosis market is projected to be worth c $8bn by 2028, which, alongside MM with a projected market value of c $33bn by 2028, represents a sizeable opportunity for Immix, even if only a modest portion of the total market is captured.
As a reminder, and as discussed in our prior note, NXC-201 is being developed by majority-owned subsidiary Nexcella. The recent readout in April 2023 from 58 patients in the Phase Ib/IIa NEXICART-1 trial showed encouraging overall response rates of 92% for MM (n=50) and 100% for ALA patients (n=8). Management plans to share updated MM clinical data at the 20th International Myeloma Society Annual Meeting on 27–30 September 2023, which could be an important catalyst for investor attention, in our view. We note that Immix completed a pre-IND meeting with the FDA in June for NXC-201 clinical trials and is now preparing to submit an IND application. It recently reported that it has completed its second NXC-201 engineering batch at its US manufacturing site.
Immix aims to differentiate NXC-201 against currently approved CAR-T therapies that are often associated with neurotoxicity and high-grade cytokine release syndrome (CRS). NXC-201 has shown a desirable safety profile to date with no reports of neurotoxicity or patient safety events greater than grade three CRS (those that occurred were associated with short onsets and durations). This may position it as the first out-patient CAR-T therapy, potentially allowing it to become more broadly accessible, which we believe may help from a regulatory point of view.
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Research: Investment Companies
The Brunner Investment Trust’s (BUT’s) two co-managers, Christian Schneider (deputy CIO global growth) and Julian Bishop (global equity specialist) are supported by deputy managers Marcus Morris-Eyton (European equity specialist) and Simon Gergel (CIO UK equities). BUT can be considered as a global equity fund for all seasons given its steady trend of outperformance in recent years despite volatile share prices and changes in stock market leadership. The trust stacks up well in both absolute and relative terms with double-digit annual NAV total returns over the last decade and above-average returns within the AIC Global sector over the last one, three and five years. BUT’s dual mandate of income and capital growth means it should appeal to a broad range of investors.