Immix Biopharma posts 89% response rate in AL amyloidosis

Posted by on Sep 29th, 2026

What happened

Immix Biopharma, Inc. (NASDAQ: IMMX) said NEXICART-2, NCT06097832, is a multi-site U.S. Phase 2 trial with a registrational design.

The study showed an 89% complete response rate, or 40 of 45 patients, based on review by an independent committee.

The company said all 25 new relapsed/refractory AL Amyloidosis patients are either in complete response or already MRD-negative. It said every patient who reached MRD-negativity also reached complete response within one year. No relapses have been seen so far in any patient who reached CR or MRD-negativity, and no neurotoxicity or enterocolitis has been seen so far.

NXC-201 is a sterically optimized BCMA-targeted CAR-T cell therapy with a proprietary CD3, CD8 hinge and binder digital filter meant to filter out non-specific activation. The company also said NXC-201 has Breakthrough Therapy Designation, RMAT and Orphan Drug Designation.

Key numbers

Metric Latest Change Source
Complete response rate across all forty-five patients 89% (40/45) SEC 8-K, Exhibit 99.1
New patients in CR or MRD-negative 100% (25/25) SEC 8-K, Exhibit 99.1
Potential future complete response rate up to 98% (44/45) SEC 8-K, Exhibit 99.1
Amyloidosis market $6.6 billion from $6.2 billion, + $0.4 billion SEC 8-K, Exhibit 99.1
U.S. relapsed/refractory AL Amyloidosis patients in 2026 approximately 30,506 patients SEC 8-K, Exhibit 99.1
Estimated annual patient growth 12% per year SEC 8-K, Exhibit 99.1

Why it matters

Immix needs proof that its CAR-T path in AL Amyloidosis is different from other options before financing pressure matters. This filing strengthens that view because it adds an interim readout with an 89% CR rate and no relapses, neurotoxicity or enterocolitis to date. NXC-201 is the lead candidate, so this is the main clinical proof point in the filing. Investors still only have an interim dataset, so the update helps but does not settle the question.

The company said four pending patients are already MRD-negative and that the future CR rate could rise to 98% (44/45), but that is only a cap, not a result. The filing says the amyloidosis market was $6.2 billion in 2025 and is expected to reach $6.6 billion in 2026, an increase of $0.4 billion. It also says the number of U.S. patients with relapsed/refractory AL Amyloidosis is estimated at about 30,506 in 2026, growing 12% a year.

What's next

NEXICART-2 final readout and BLA submission are planned in 2027. The company will host a conference call to discuss these data at 8:00 a.m. ET today, Sep 29, 2026.

A later readout that keeps the 89% CR rate and the no-relapse, no-neurotoxicity and no-enterocolitis profile would strengthen the program's case. Any slip in those figures, or in the 2027 timing, would weaken it. The live webcast can be accessed at the link in the release, and it will be available for replay on the company website.

Sources

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Originally published on OptimistFi, evidence-first equity research. More at optimistfi.com.