Hematogenix's MM MRD Assay Underpins FDA Accelerated Approval of Bristol Myers Squibb's ZENBEXUS™, the First Approved CELMoD Therapy for Multiple Myeloma

Hematogenix said its proprietary MM MRD assay was used to measure the primary efficacy endpoint cited in the FDA’s accelerated approval of ZENBEXUS, also known as iberdomide. The announcement was issued from Tinley Park, Illinois, on August 19, 2026, and describes ZENBEXUS as the first approved CELMoD therapy for multiple myeloma.

The direct corporate read-through is to Bristol Myers Squibb, whose drug received the regulatory decision, while Hematogenix is presented as the specialized trial-services and biomarker company supporting the registration. No approval sales forecast, label detail beyond the accelerated-approval designation, or commercial terms between the companies were provided.

The next datapoints are the confirmatory evidence required for the accelerated approval, the timing and scale of the ZENBEXUS launch, and any disclosures from BMY on pricing, uptake, or portfolio impact. The supplied financial snapshot shows BMY with FY2025 revenue of $48.2B, down 0.2% year over year, a 14.6% net margin, and $3.46 diluted EPS, but it does not isolate this therapy’s contribution.