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VIVS-News
VIVS-Events
VivoSim Celebrates FDA Rule Allowing Non-Animal Testing
VivoSim celebrated the 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.
VivoSim Files to Sell 9.41M Shares of Common Stock
VivoSim files to sell 9.41M shares of common stock for holders
VivoSim Announces First Commercial Sales of NAMkind Testing Services in China
VivoSim announced its first commercial sales in China, opening a new market for its NAMkind testing services. VivoSim delivers both toxicology and efficacy testing built on its 3D human tissue models of the liver and gastrointestinal tract. The two initial engagements, with a Shanghai-based oncology biotech and a large Chengdu-based pharmaceutical company, represent the company's first paid programs on the Chinese mainland and a milestone in VivoSim's expansion across Asia-Pacific.
VivoSim Receives $5M Milestone Payment from Eli Lilly
VivoSim (VIVS) announced that it has received a $5M payment from Eli Lilly (LLY). In association with its former inflammatory bowel disease drug program developed previously and sold outright to Eli Lilly, VivoSim has received $5M as a milestone payment. The payment represents the dosing of the first patient in Phase 2 studies of the drug in Eli Lilly's development program. The drug's development is entirely guided by Eli Lilly, but VivoSim remains eligible for up to $45M in additional milestone payments over time as the drug is developed and commercially marketed, provided it is able to hit key regulatory and commercial milestones.
VivoSim Anticipates Over 500% Revenue Growth in FY 2027
The company said, "VivoSim further announced that it anticipates significant revenue growth in Fiscal Year 2027 given its progress in marketing contract research services using NAMs models to pharmaceutical companies. The company anticipates over 500% revenue growth in the fiscal year, due to customer response to the predictive power of its NAMs models, which are building traction with a wide set of customers. VivoSim's superior results are achieved by a combination of the best biological model with the most representative primary human cell types, leveraging multiple endpoints as readouts for best prediction, and training AI prediction models with multiple endpoints that provide a rich data set, yielding high prediction accuracy. In addition to testing traditional small molecules, VivoSim is establishing competitive advantages across new biotech modalities such as antibody drug conjugates, antibodies, siRNA, and gene therapies. Many therapies still fail in human trials, most often on safety or efficacy. VivoSim's mission is to close gaps in the ability to predict outcomes before a drug enters expensive clinical trials. In recent months, VivoSim has demonstrated that its NAMkind Liver spheroid model achieved a predictive accuracy of 91%, with 90% sensitivity, 95% specificity, and 99% precision under repeat-dose conditions. The multi-endpoint profiling suite effectively minimized false negatives and successfully resolved intra-class toxicities, such as within thiazolidinediones. Similarly, the company's NAMkind Intestine models deliver greater than 90% sensitivity and overall accuracy for the prediction of drug-induced diarrhea."
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