FDA Considers Noninvasive Endpoint for MASH Trials, Boosts Biotech Shares
The FDA announced it is considering noninvasive biomarkers as alternative endpoints to liver biopsy in clinical trials for MASH (formerly known as NASH) therapies15.
This proposal aims to provide safer, more accessible, and less burdensome ways to monitor disease progression and treatment efficacy, potentially improving trial recruitment and execution1.
The move is viewed as a significant advancement by the biotech sector and has resulted in increased stock prices for several MASH-focused biotech companies, including Madrigal Pharmaceuticals, Viking Therapeutics, Inventiva, and Altimmune1.
Adopting noninvasive endpoints is expected to help reduce variability and placebo response rates typically associated with pathologist-based and biopsy-driven assessments1.
The exact timing and details of implementation remain limited, but analysts regard the FDA's shift away from biopsy as an encouraging development for the field15.
This regulatory shift comes alongside recent accelerated approvals in the MASH space, such as Novo Nordisk’s Wegovy and Madrigal’s Rezdiffra, which now compete in the newly emerging therapeutic market24.
Sources:
1. https://www.fiercebiotech.com/biotech/fda-considers-non-invasive-liver-endpoint-trials-sending-mash-biotechs-stock
2. https://medcitynews.com/2025/08/novo-nordisk-wegovy-mash-fda-approval-fatty-liver-disease-metabolic-semaglutide-glp1/
4. https://www.fiercepharma.com/pharma/novos-wegovy-picks-3rd-indication-fda-approval-severe-liver-disease-mash