Resoundant’s Magnetic Resonance Elastography Accepted into FDA Biomarker Qualification Program as a Reasonably Likely Surrogate Endpoint in MASH Trials

Rochester, MN — December 16, 2025 — Resoundant, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Letter of Intent into the FDA’s Biomarker Qualification Program (BQP) for Liver Stiffness Measurement (LSM) by Magnetic Resonance Elastography (MRE) as a Reasonably Likely Surrogate Endpoint (RLSE) in clinical trials for adults with noncirrhotic metabolic dysfunction–associated steatohepatitis (MASH) with moderate to advanced fibrosis (F2–F3).

Acceptance into the BQP represents an important step in the FDA’s formal biomarker qualification process and reflects the agency’s openness to outcome-linked, non-invasive tests (NITs) that may improve the efficiency and feasibility of MASH drug development. The proposed context of use positions MRE as a quantitative biomarker intended to support assessment of fibrosis burden and its relationship to the risk of liver-related events and outcomes.

Fibrosis progression is the primary driver of adverse clinical outcomes in MASH. However, reliance on liver biopsy in clinical trials presents well-recognized challenges, including procedural risk, sampling variability, reader discordance, high cost, and barriers to patient recruitment and retention. These limitations have contributed to longer timelines and increased development complexity across the field.

MRE is an MRI-based technique that directly measures the mechanical properties of liver tissue and provides a continuous and reproducible assessment of fibrosis burden, enabling longitudinal evaluation without repeated invasive procedures. Advancing MRE within the FDA’s biomarker qualification framework has the potential to reduce reliance on biopsy and support more efficient, scalable, and patient-friendly clinical trial designs.

“There is growing alignment across regulators, academia, and industry around the need for non-invasive endpoints that are biologically grounded, reproducible, and suitable for longitudinal assessment,” said Kay Pepin, PhD, Chief Operating Officer of Resoundant. “The FDA’s acceptance of our Letter of Intent reflects that MRE is well aligned with this direction, and we look forward to advancing the qualification plan in close collaboration with the agency.”

Following acceptance of the Letter of Intent, Resoundant will proceed with submission of a Qualification Plan, addressing FDA feedback and outlining the analytical and clinical validation activities required to support biomarker qualification. The final scope and regulatory utility of MRE as a surrogate endpoint will be determined by the totality of evidence reviewed by the FDA.