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Adaptive Biotechnologies Shares Surge as FDA Panel Recommends MRD as Endpoint in Multiple Myeloma

NEW YORK – Shares of Adaptive Biotechnologies climbed 15 percent on Friday afternoon, closing at $3.01, after a US Food and Drug Administration panel unanimously approved minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma drug trials.

Seattle-based Adaptive offers the FDA-cleared ClonoSeq assay for MRD testing in hematologic cancers, including multiple myeloma. The vote from FDA's Center for Drug Evaluation and Research Oncologic Drugs Advisory Committee became public Friday afternoon.

"Many of the 12 voters called today's committee [meeting] a 'Herculean day' for multiple myeloma, and we would argue that today marked a Herculean day also for MRD as an important category of diagnostic testing not only for clinical use, but importantly, for biopharma use in clinical trials," BTIG Analyst Mark Massaro wrote in a note to investors. "Without a doubt, we think today's events are positive for [Adaptive], which is the market leader of hematological MRD testing."

MRD studies in multiple myeloma use the sequencing-based Adaptive assay or multiparametric flow cytometry, both of which have a sensitivity of 1 in 100,000 cells.

Massaro added that Natera may also ultimately benefit from the decision, predicting that MRD may be used more often as a clinical trial endpoint for solid tumors.

While the panel vote is not the final step in approving MRD as an endpoint, he said he expects the FDA to follow the recommendation.

In Monday morning trading on the Nasdaq, shares of Adaptive remained flat at $3.05.