VivoSim Labs (VIVS) FDA Approvals $0.26 -0.01 (-4.22%) As of 12:11 PM Eastern This is a fair market value 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 Abeona Therapeutics FDA EventsArtelo Biosciences FDA EventsBiogen FDA EventsFate Therapeutics FDA EventsHarmony Biosciences FDA EventsVivoSim Labs FDA EventsMedtronic FDA EventsArrowhead Pharmaceuticals FDA EventsBioVie FDA EventsBlossomHill Therapeutics FDA EventsConnect Biopharma FDA EventsCogent Biosciences FDA EventsErnexa Therapeutics FDA EventsGT Biopharma FDA EventsOcular Therapeutix 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 Revvity 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. 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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
