VivoSim Labs Celebrates Updated FDA Regulations Allowing Greater use of Non-Animal Testing Methods
https://www.globenewswire.com/news-release/20...thods.html
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.
VivoSim's liver tissue models are capable of flagging drug candidates likely to cause liver toxicity, side effects like diarrhea, and other issues. Liver toxicity is the leading cause of drug failures and market withdrawals. The company has the ability to meaningfully de-risk a client company’s set of compounds and rule out likely failures prior to its selection of a drug to enter clinical testing.
Drug-induced liver injury (DILI) and gastrointestinal (GI) toxicity remain leading causes of drug candidate attrition. VivoSim's findings demonstrate how its long-duration, primary human cell-based models can help identify and differentiate these risks earlier in development, successfully ranking clinical safety risks for clients’ drug candidates.
“VivoSim’s NAMkind Models give insights that let our pharma and biotech partners make fewer major mistakes,” said Keith Murphy, VivoSim’s Executive Chairman. “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.”
By offering these kinds of insights, VivoSim also is helping with society’s goal of lowering the cost of medicines for patients. The cited costs of up to $2B per approved drug actually reflects the cost of eleven failed drugs for every one approved drug. VivoSim expects such wins to pass on to patients in lower drug costs through more approved drugs, greater competition, and lower pricing needed to recover a fair profit. “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%,” Murphy noted.
https://www.globenewswire.com/news-release/20...thods.html
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.
VivoSim's liver tissue models are capable of flagging drug candidates likely to cause liver toxicity, side effects like diarrhea, and other issues. Liver toxicity is the leading cause of drug failures and market withdrawals. The company has the ability to meaningfully de-risk a client company’s set of compounds and rule out likely failures prior to its selection of a drug to enter clinical testing.
Drug-induced liver injury (DILI) and gastrointestinal (GI) toxicity remain leading causes of drug candidate attrition. VivoSim's findings demonstrate how its long-duration, primary human cell-based models can help identify and differentiate these risks earlier in development, successfully ranking clinical safety risks for clients’ drug candidates.
“VivoSim’s NAMkind Models give insights that let our pharma and biotech partners make fewer major mistakes,” said Keith Murphy, VivoSim’s Executive Chairman. “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.”
By offering these kinds of insights, VivoSim also is helping with society’s goal of lowering the cost of medicines for patients. The cited costs of up to $2B per approved drug actually reflects the cost of eleven failed drugs for every one approved drug. VivoSim expects such wins to pass on to patients in lower drug costs through more approved drugs, greater competition, and lower pricing needed to recover a fair profit. “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%,” Murphy noted.
