Metagenomi (MGX) FDA Approvals $1.16 0.00 (0.00%) Closing price 09/11/2026 04:00 PM EasternExtended Trading$1.16 +0.01 (+0.43%) As of 09/11/2026 07:52 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 EventsFinancialsInsider TradesNews and TrendsOwnershipSEC Filings Metagenomi's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Metagenomi (MGX). Over the past two years, Metagenomi has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as MGX-001. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. MGX-001 FDA Regulatory Events MGX-001 is a drug developed by Metagenomi for the following indication: Hemophilia A gene editing investigational therapy. 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 - November 11,2025Data Drug: MGX-001Announced Date: November 11, 2025Indication: Hemophilia A gene editing investigational therapyAnnouncementMetagenomi, Inc. reported new dose range finding data from the Company's MGX-001 hemophilia A program.AI SummaryMetagenomi reported dose range finding results for MGX-001, a one-time genome editing therapy for hemophilia A, showing curative factor VIII (FVIII) activity in non-human primates. In a study of 24 animals across six AAV dose cohorts (5.0e11–4.0e13 vg/kg), each followed by a single LNP dose (0.2, 0.6 or 2.0 mg/kg) delivering the MG29-1 nuclease mRNA and guide RNA, therapeutically relevant FVIII levels were achieved in the five highest AAV dose groups. With LNP fixed at 0.6 mg/kg and AAV from 1.6e12–4e13 vg/kg, cohort averages ranged from 49% to 81% of normal FVIII. FVIII activity showed clear dependence on both AAV and LNP doses, and no animal exceeded 150% of normal. At a proposed clinical dose (AAV 5e12 vg/kg; LNP 0.6 mg/kg) average FVIII was 49% (range 29.3%–59.5%). The treatment was generally well tolerated, with only transient liver enzyme rises at the highest LNP dose. Orthogonal assays detected no identifiable off‑target editing. Metagenomi says these data support advancing MGX-001 toward clinical development as a potential one‑and‑done curative approach.Read AnnouncementData Presentation - December 9,2024Data Presentation Drug: MGX-001Announced Date: December 9, 2024Indication: Hemophilia A gene editing investigational therapyAnnouncementMetagenomi, Inc. presented updated preclinical NHP data for its hemophilia A program in an oral presentation (link here) at the American Society of Hematology (ASH) 66th Annual Meeting and Exposition in San Diego.AI SummaryMetagenomi, Inc. recently presented updated preclinical data on its hemophilia A program at the American Society of Hematology’s 66th Annual Meeting in San Diego. The company highlighted results from an ongoing nonhuman primate (NHP) study where therapeutically relevant levels of Factor VIII (FVIII) activity were maintained for over 16 months. This study demonstrated that their bioengineered FVIII construct, used in MGX-001, achieved higher FVIII activity compared to the wild type, even with similar gene integration rates. The findings support the proof-of-concept behind their unique gene editing approach, which integrates the FVIII gene in vivo, potentially offering a one-time curative treatment for hemophilia A patients. These encouraging results are a crucial milestone as the company moves forward with MGX-001 toward clinical development, with an IND filing targeted for 2026.Read Announcement Metagenomi FDA Events - Frequently Asked Questions Has Metagenomi received FDA approval? As of now, Metagenomi (MGX) has not received any FDA approvals for its therapy in the last two years. What drugs has Metagenomi submitted to the FDA? In the past two years, Metagenomi (MGX) has reported FDA regulatory activity for MGX-001. What is the most recent FDA event for Metagenomi? The most recent FDA-related event for Metagenomi occurred on November 11, 2025, involving MGX-001. The update was categorized as "Data," with the company reporting: "Metagenomi, Inc. reported new dose range finding data from the Company's MGX-001 hemophilia A program." What conditions do Metagenomi's current drugs treat? Currently, Metagenomi has one therapy (MGX-001) targeting the following condition: Hemophilia A gene editing investigational therapy. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Agenus FDA EventsBioLineRx FDA EventsCAMP4 Therapeutics FDA EventsCompass Pathways FDA EventsJaguar Animal Health FDA EventsLegend Biotech FDA EventsLyell Immunopharma FDA EventsMedicus Pharma FDA EventsOncolytics Biotech FDA EventsOptimi Health FDA EventsOncobiologics FDA EventsPrelude Therapeutics FDA EventsVerrica Pharmaceuticals FDA EventsAbbVie FDA EventsAscendis Pharma A/S 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 Moderna FDA Events Caribou Biosciences FDA Events MediWound FDA Events Spruce Biosciences FDA Events Humacyte FDA Events Tenaya Therapeutics FDA Events ADC Therapeutics FDA Events Oncobiologics FDA Events OnKure Therapeutics FDA Events Connect Biopharma FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:MGX last updated on 11/11/2025 by MarketBeat.com Staff. 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Data - November 11,2025Data Drug: MGX-001Announced Date: November 11, 2025Indication: Hemophilia A gene editing investigational therapyAnnouncementMetagenomi, Inc. reported new dose range finding data from the Company's MGX-001 hemophilia A program.AI SummaryMetagenomi reported dose range finding results for MGX-001, a one-time genome editing therapy for hemophilia A, showing curative factor VIII (FVIII) activity in non-human primates. In a study of 24 animals across six AAV dose cohorts (5.0e11–4.0e13 vg/kg), each followed by a single LNP dose (0.2, 0.6 or 2.0 mg/kg) delivering the MG29-1 nuclease mRNA and guide RNA, therapeutically relevant FVIII levels were achieved in the five highest AAV dose groups. With LNP fixed at 0.6 mg/kg and AAV from 1.6e12–4e13 vg/kg, cohort averages ranged from 49% to 81% of normal FVIII. FVIII activity showed clear dependence on both AAV and LNP doses, and no animal exceeded 150% of normal. At a proposed clinical dose (AAV 5e12 vg/kg; LNP 0.6 mg/kg) average FVIII was 49% (range 29.3%–59.5%). The treatment was generally well tolerated, with only transient liver enzyme rises at the highest LNP dose. Orthogonal assays detected no identifiable off‑target editing. Metagenomi says these data support advancing MGX-001 toward clinical development as a potential one‑and‑done curative approach.Read Announcement
Data Presentation - December 9,2024Data Presentation Drug: MGX-001Announced Date: December 9, 2024Indication: Hemophilia A gene editing investigational therapyAnnouncementMetagenomi, Inc. presented updated preclinical NHP data for its hemophilia A program in an oral presentation (link here) at the American Society of Hematology (ASH) 66th Annual Meeting and Exposition in San Diego.AI SummaryMetagenomi, Inc. recently presented updated preclinical data on its hemophilia A program at the American Society of Hematology’s 66th Annual Meeting in San Diego. The company highlighted results from an ongoing nonhuman primate (NHP) study where therapeutically relevant levels of Factor VIII (FVIII) activity were maintained for over 16 months. This study demonstrated that their bioengineered FVIII construct, used in MGX-001, achieved higher FVIII activity compared to the wild type, even with similar gene integration rates. The findings support the proof-of-concept behind their unique gene editing approach, which integrates the FVIII gene in vivo, potentially offering a one-time curative treatment for hemophilia A patients. These encouraging results are a crucial milestone as the company moves forward with MGX-001 toward clinical development, with an IND filing targeted for 2026.Read Announcement
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