VivoSim Labs appoints Dr. Amar Sethi as Chief Scientific Officer to enhance its drug testing capabilities and biomarker insights.
Quiver AI Summary
VivoSim Labs, Inc. has appointed Dr. Amar Sethi as its new Chief Scientific Officer, bringing three decades of experience in pharmaceutical drug development and clinical research. Dr. Sethi's appointment comes at a crucial time as VivoSim focuses on expanding its capabilities in drug testing using three-dimensional human tissue models, specifically for liver and intestinal toxicity. His extensive background includes leading global clinical programs, developing FDA-qualified biomarkers, and enhancing scientific governance. Dr. Sethi will oversee the company's scientific strategy, particularly in toxicology and translation methodologies, while collaborating with R&D and AI teams to improve toxicity predictions. This leadership shift aims to position VivoSim as a preferred partner in the evolving landscape of pharmaceutical testing, particularly in the wake of recent FDA moves towards non-animal testing models.
Potential Positives
- Appointment of Dr. Amar Sethi as Chief Scientific Officer brings extensive experience in drug development and biomarker innovation, enhancing the company’s leadership team.
- Dr. Sethi's expertise in regulatory compliance and clinical programs positions VivoSim to strengthen its scientific governance and increase credibility with pharmaceutical sponsors.
- The announcement capitalizes on the anticipated acceleration of 3D human tissue model adoption following recent FDA policy changes, potentially expanding VivoSim’s market opportunities.
- Integration of 3D biology with AI-driven analytics under Dr. Sethi’s leadership aims to improve toxicology predictions, supporting faster and more effective drug development for partners.
Potential Negatives
- The press release highlights the company's reliance on forward-looking statements, which come with inherent risks and uncertainties, potentially undermining investor confidence.
- The mention of potential non-adoption of the company's services and market opportunities raises concerns about the viability of the NAM models and long-term growth.
- Dr. Sethi's appointment, while presenting a wealth of experience, may indicate previous challenges in leadership that necessitated this high-level recruitment at a pivotal moment for the company.
FAQ
Who has been appointed as the Chief Scientific Officer of VivoSim Labs?
Amar Sethi, M.D., Ph.D. has been appointed as Chief Scientific Officer at VivoSim Labs.
What is the primary focus of VivoSim Labs, Inc.?
VivoSim Labs focuses on drug testing using three-dimensional human tissue models of the liver and intestine.
What experience does Dr. Amar Sethi bring to VivoSim Labs?
Dr. Sethi has three decades of experience in pharmaceutical drug development, clinical programs, and biomarker innovation.
How does VivoSim Labs enhance toxicology predictions?
VivoSim Labs uses 3D biology and AI-driven analytics for multi-parametric toxicity predictions and decision-making insights.
What is the significance of the FDA's announcement on April 10, 2025?
The FDA's announcement supports the adoption of non-animal testing methods, benefiting VivoSim’s human tissue models.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$VIVS Insider Trading Activity
$VIVS insiders have traded $VIVS stock on the open market 1 times in the past 6 months. Of those trades, 0 have been purchases and 1 have been sales.
Here’s a breakdown of recent trading of $VIVS stock by insiders over the last 6 months:
- DAVID GOBEL sold 3,266 shares for an estimated $7,299
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$VIVS Hedge Fund Activity
We have seen 15 institutional investors add shares of $VIVS stock to their portfolio, and 11 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- DRW SECURITIES, LLC added 67,482 shares (+inf%) to their portfolio in Q3 2025, for an estimated $197,047
- CITADEL ADVISORS LLC removed 57,493 shares (-100.0%) from their portfolio in Q3 2025, for an estimated $167,879
- HRT FINANCIAL LP added 31,602 shares (+inf%) to their portfolio in Q3 2025, for an estimated $92,277
- TWO SIGMA INVESTMENTS, LP added 23,192 shares (+inf%) to their portfolio in Q3 2025, for an estimated $67,720
- TWO SIGMA SECURITIES, LLC added 18,214 shares (+inf%) to their portfolio in Q3 2025, for an estimated $53,184
- GEODE CAPITAL MANAGEMENT, LLC added 17,945 shares (+inf%) to their portfolio in Q3 2025, for an estimated $52,399
- SUSQUEHANNA INTERNATIONAL GROUP, LLP removed 16,727 shares (-100.0%) from their portfolio in Q3 2025, for an estimated $48,842
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
SAN DIEGO, Jan. 06, 2026 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (Nasdaq: VIVS) (the “Company” or “VivoSim Labs”), a pharmaceutical and biotechnology services company that is focused on providing testing of drugs and drug candidates in three-dimensional (“3D”) human tissue models of liver and intestine, announces it has appointed Amar Sethi, M.D., Ph.D. as its Chief Scientific Officer.
Dr. Sethi is a transformational R&D executive with three decades of experience encompassing pharmaceutical drug development, CRO leadership, translational medicine, and diagnostic innovation. He has led global Phase I–IV clinical programs, FDA breakthrough and orphan drug designations, BLA filings, and advanced biomarker strategies across metabolic disorders, nephrology, hematology, rare diseases, and cardiovascular biology. His expertise includes establishing CAP/CLIA/GCP/GLP-compliant infrastructures, scaling bioanalytical and biomarker teams, and guiding scientific strategy for both early and late-stage assets.
At VivoSim, Dr. Sethi will lead scientific strategy across toxicology, translational models, bioanalytics, and next-generation new approach methodologies (NAMs) methodologies. He will expand the company’s biomarker and mechanistic insight capabilities, strengthen scientific governance for pharmaceutical sponsors, and collaborate closely with R&D, platform engineering, and AI teams to enhance multi-parametric toxicity prediction using human-relevant systems.
Dr. Sethi’s career bridges drug-development leadership with biomarker innovation. At Omeros Corp, he led a pivotal global Phase 3 program for a Breakthrough Therapy/Orphan-designated biologic and supported multiple monoclonal antibody programs now approved or advancing into late stages. As President & Chief Medical Officer of Pacific Biomarkers, he drove 70% business growth, led successful M&A initiatives, and developed FDA-qualified novel biomarker platforms, including a gold-standard Acute Kidney Injury panel uniquely qualified by the FDA. His tenure at NIH and Copenhagen University Hospitals further established him as a scientific authority in clinical chemistry, cardiometabolic research, and translational diagnostics.
“VivoSim’s NAMkind platform is redefining human-relevant toxicology,” said Dr. Amar Sethi, Chief Scientific Officer, VivoSim Labs. “By integrating advanced 3D biology with AI-driven analytics, we can generate mechanistic clarity and decision-ready insights earlier—helping sponsors mitigate risk, accelerate development, and optimize portfolio strategy.”
“Amar brings an exceptional combination of scientific depth, clinical insight, and operational leadership,” said Keith Murphy, Executive Chairman, VivoSim Labs. “His expertise in biomarkers, translational medicine, and regulatory-grade data generation strengthens VivoSim at a pivotal moment. As sponsors increasingly adopt 3D NAM systems, Amar will ensure that VivoSim remains the scientific partner of choice.”
The Thorough Group, an independent recruitment firm specializing in the life sciences, assisted VivoSim with the placement of Dr. Sethi.
About VivoSim Labs
VivoSim Labs, Inc. ("VivoSim" and the “Company”), is a pharmaceutical and biotechnology services company that is focused on providing testing of drugs and drug candidates in three-dimensional (“3D”) human tissue models of liver and intestine. The Company offers partners liver and intestinal toxicology insights using its new approach methodologies ("NAM") models. The Company anticipates accelerated adoption of human tissue models following the U.S. Food and Drug Administration (“FDA") announcement on April 10, 2025 to refine animal testing requirements in favor of these non-animal NAM methods. VivoSim Labs operates from San Diego, CA. Visit www.vivosim.ai.
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Forward-looking statements include statements regarding expansion of the Company’s San Diego-based services; the potential for the Company’s organ-specific 3D models and AI-driven analytics to deliver decision-ready insights earlier in development; the market opportunity and market size of gastrointestinal in-vitro models and toxicology services; and the ability of the Company’s services to improve signal-to-noise in dose-response calls or help project teams prioritize candidates and studies with greater confidence. Such forward-looking statements are not guarantees of performance and actual actions or events could differ materially from those contained in such statements. These risks and uncertainties and other factors are identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on June 5, 2025, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on November 6, 2025. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events, or circumstances or to reflect the occurrence of unanticipated events.
Contact
Investor Relations
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VivoSim Labs, Inc.