VivoSim Labs (VIVS) FDA Approvals $0.18 +0.00 (+1.64%) Closing price 10/9/2026 04:00 PM EasternExtended Trading$0.18 0.00 (-1.17%) As of 10/9/2026 07:49 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsNews and TrendsOwnershipSEC Filings VivoSim Labs' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by VivoSim Labs (VIVS). Over the past two years, VivoSim Labs has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as NAMkind. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. NAMkind FDA Regulatory Events NAMkind is a drug developed by VivoSim Labs for the following indication: in Liver and Gastrointestinal Safety Across Small Molecules and ADCs. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Data - September 16,2026Data Drug: NAMkindAnnounced Date: September 16, 2026Indication: in Liver and Gastrointestinal Safety Across Small Molecules and ADCsAnnouncementVivoSim Labs, Inc. unveils new clinical benchmark data at the 58th Congress of the European Societies of Toxicology (EUROTOX 2026) in Vienna, Austria, demonstrating the ability of its NAMkind™ 3D human liver and intestinal platforms to predict drug toxicity across small molecules and increasingly complex therapies, including Antibody-Drug Conjugates (ADCs).Read Announcement VivoSim Labs FDA Events - Frequently Asked Questions Has VivoSim Labs received FDA approval? As of now, VivoSim Labs (VIVS) has not received any FDA approvals for its therapy in the last two years. What drugs has VivoSim Labs submitted to the FDA? In the past two years, VivoSim Labs (VIVS) has reported FDA regulatory activity for NAMkind. What is the most recent FDA event for VivoSim Labs? The most recent FDA-related event for VivoSim Labs occurred on September 16, 2026, involving NAMkind. The update was categorized as "Data," with the company reporting: "VivoSim Labs, Inc. unveils new clinical benchmark data at the 58th Congress of the European Societies of Toxicology (EUROTOX 2026) in Vienna, Austria, demonstrating the ability of its NAMkind™ 3D human liver and intestinal platforms to predict drug toxicity across small molecules and increasingly complex therapies, including Antibody-Drug Conjugates (ADCs)." What conditions do VivoSim Labs' current drugs treat? Currently, VivoSim Labs has one therapy (NAMkind) targeting the following condition: in Liver and Gastrointestinal Safety Across Small Molecules and ADCs. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Alumis FDA EventsArcutis Biotherapeutics FDA EventsBioMarin Pharmaceutical FDA EventsHCW Biologics FDA EventsMilestone Pharmaceuticals FDA EventsPureTech Health FDA EventsGlaukos FDA EventsJohnson & Johnson FDA EventsEli Lilly and Company FDA EventsTeva Pharmaceutical Industries FDA EventsAddex Therapeutics FDA EventsAclarion FDA EventsAgomAb Therapeutics FDA EventsCRISPR Therapeutics FDA EventsDare Bioscience FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Agilent Technologies FDA Events Qiagen FDA Events Adaptive Biotechnologies FDA Events Personalis FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:VIVS last updated on 9/16/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersThe investigation Porter spent tens of thousands to documentPorter Stansberry flew the Porter and Co. team 3,300 miles to Dublin to investigate a 17-year investing experi...Porter & Company | SponsoredThis free guide explains options the way they should be taughtMost options educators jump straight into Greeks, spreads, and implied volatility - losing beginners before th...Base Camp Trading | SponsoredNew Chip takes minutes, not daysGeorge Gilder believes today's AI data centers could become tomorrow's typewriters - replaced by a single wafe...Eagle Publishing | SponsoredThe only 5 stocks that matterSpaceX's IPO reportedly minted 4,400 new millionaires, and OpenAI is said to be eyeing a 1 trillion dollar IPO...TradeSmith | SponsoredSmall Colorado Company (Backed by Sam Altman) Could Save U.S. Power GridA small Colorado company has secured rights to technology that could prevent the U.S. public power grid from c...Altimetry | SponsoredTrump goes "all-in" on Grand Canyon energy breakthroughA drilling crew near the Grand Canyon uncovered a clean energy well producing nearly eight times the output of...Behind the Markets | SponsoredA simple options setup that cuts through the noiseIan Cooper says most options traders overcomplicate the process, juggling countless indicators, strategies, an...TradeWins | SponsoredA major gold reset could be closer than people thinkFor 50 years, Washington has held 8,133 tonnes of gold on its books at a fraction of today's market price. One...Reagan Gold Group | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding VivoSim Labs, Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share VivoSim Labs With A Colleague Link copied to clipboard. Unlock superior investment research and tools. Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools and reports. Get MarketBeat All Access MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Data - September 16,2026Data Drug: NAMkindAnnounced Date: September 16, 2026Indication: in Liver and Gastrointestinal Safety Across Small Molecules and ADCsAnnouncementVivoSim Labs, Inc. unveils new clinical benchmark data at the 58th Congress of the European Societies of Toxicology (EUROTOX 2026) in Vienna, Austria, demonstrating the ability of its NAMkind™ 3D human liver and intestinal platforms to predict drug toxicity across small molecules and increasingly complex therapies, including Antibody-Drug Conjugates (ADCs).Read Announcement
