VivoSim Labs Celebrates Updated FDA Regulations Allowing Greater use of Non-Animal Testing Methods
Key Highlights
- ➤FDA final rule replaces “animal tests” with “nonclinical tests,” opening pathways for NAMs
- ➤VivoSim offers 3D human liver and intestine models for preclinical toxicity testing
- ➤VivoSim models identify liver and gastrointestinal toxicity risks earlier in drug development
- ➤Keith Murphy says partners avoid spending $50 to $200M on late-stage failures
- ➤Murphy says raising clinical-trial success from 8% to 30% could halve development costs
Expert Statements
Keith Murphy, Executive Chairman of VivoSim Labs
“VivoSim’s NAMkind Models give insights that let our pharma and biotech partners make fewer major mistakes,”
Keith Murphy, Executive Chairman of VivoSim Labs
“By identifying risky molecules early on in development and moving on to better candidates, they avoid spending $50 to $200M only to learn deep in human clinical trials that their drug’s results in animals were not representative.”
Keith Murphy, Executive Chairman of VivoSim Labs
“If we can help the world get from an 8% success rate in clinical trials to a 30% success rate, it would reduce the cost of drug development by 50%,”
SAN DIEGO, Oct. 07, 2026 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (Nasdaq: VIVS) (the “Company” or “VivoSim”), a provider of next-generation New Approach Methodologies (NAM) 3d human cellular models for preclinical safety, today celebrated the U.S. Food and Drug Administration's (FDA) direct final rule updating its regulations to clarify that non-animal methods can be used where appropriate for testing the safety of drugs and biological products intended for human use.
The FDA’s new rule replaces the term "animal tests" with "nonclinical tests" across its regulatory framework, formally opening pathways for NAMs, including human cell-based tests such as those offered by VivoSim.
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