Greenstone Biosciences, a biotechnology company advancing New Approach Methodologies (NAMs) for drug discovery, announced that it has received a Catalyze R61 award from the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health (NIH). The award funds a research program to discover novel drug candidates for myocardial fibrosis and dilated cardiomyopathy in Duchenne muscular dystrophy (DMD).

Greenstone Biosciences combines one of the world’s largest human iPSC biobanks with advanced omics, AI, and human-relevant disease models to support target discovery, drug screening, and translational development.DMD is a rare genetic disorder, affecting about one in every 3,500 baby boys worldwide. Heart problems, especially cardiomyopathy, are common in people with DMD and are the main cause of death. Corticosteroids can help delay heart failure and improve survival, but more than a quarter of patients either cannot tolerate them or do not respond to this treatment. Currently, there is no approved therapy that directly tackles the heart scarring caused by the disease, which is exactly what this program aims to address.

Using its induced pluripotent stem cell (iPSC) biobank and cardiomyocyte disease models, Greenstone will combine unbiased proteomics, computational drug screening, and generative AI to identify and validate new drug candidates for DMD cardiomyopathy. The Catalyze program is structured in two phases. The current R61 phase supports target identification and early candidate discovery. If successful, the program will advance to an R33 phase, which would fund the synthesis, characterization, and testing of promising compounds in vivo before moving on to IND-enabling studies.

"DMD cardiomyopathy has gone unaddressed for too long, in part because the tools to model it faithfully in the lab have not existed," said Dr. Joseph C. Wu, co-founder of Greenstone Biosciences [and Director of the Stanford Cardiovascular Institute]. "This award lets us apply patient-derived cardiomyocyte models and modern computational methods to a disease where the biology has been difficult to reach any other way."

The award comes at a time when the regulatory landscape for NAMs is rapidly evolving. The FDA's 2025 Roadmap to Reduce Animal Testing and its April 2026 progress report have officially made the ISTAND program permanent, created a NAMs Acceptability Database, and approved the agency's first AI-based drug development tool for clinical trials. Meanwhile, Congress has advanced the FDA Modernization Act 3.0, which would align the agency's regulations with the nonclinical testing authority granted in 2022. The bill passed the House on July 20, 2026, and now awaits a final Senate vote before heading to the President. These developments represent some of the strongest legislative and regulatory support yet for human-relevant models in drug development.