Vogenx (VOGX) FDA Approvals $14.53 -1.52 (-9.47%) As of 10/16/2026 04:00 PM Eastern Add Share Share FDA Events Stock AnalysisAnalyst ForecastsChartEarningsFDA EventsNews and TrendsSEC Filings Vogenx's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Vogenx (VOGX). Over the past two years, Vogenx has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as VGX-001-013. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. VGX-001-013 FDA Regulatory Events VGX-001-013 is a drug developed by Vogenx for the following indication: for Post-Bariatric Hypoglycemia. 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. Initiation - October 15,2026Initiation Drug: VGX-001-013Announced Date: October 15, 2026Indication: for Post-Bariatric HypoglycemiaAnnouncementVogenx, Inc. announced the initiation of EMERGE (VGX-001-013), its Phase 2b clinical trial evaluating mizagliflozin for the treatment of post-bariatric hypoglycemia (PBH).Read Announcement Vogenx FDA Events - Frequently Asked Questions Has Vogenx received FDA approval? As of now, Vogenx (VOGX) has not received any FDA approvals for its therapy in the last two years. What drugs has Vogenx submitted to the FDA? In the past two years, Vogenx (VOGX) has reported FDA regulatory activity for VGX-001-013. What is the most recent FDA event for Vogenx? The most recent FDA-related event for Vogenx occurred on October 15, 2026, involving VGX-001-013. The update was categorized as "Initiation," with the company reporting: "Vogenx, Inc. announced the initiation of EMERGE (VGX-001-013), its Phase 2b clinical trial evaluating mizagliflozin for the treatment of post-bariatric hypoglycemia (PBH)." What conditions do Vogenx's current drugs treat? Currently, Vogenx has one therapy (VGX-001-013) targeting the following condition: for Post-Bariatric Hypoglycemia. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Ascendis Pharma A/S FDA EventsIonis Pharmaceuticals FDA EventsOmeros FDA EventsRegeneron Pharmaceuticals FDA EventsSanofi FDA EventsTiziana Life Sciences FDA EventsTango Therapeutics FDA EventsOrganon & Co. FDA EventsAquestive Therapeutics FDA EventsCrescent Biopharma FDA EventsCellectar Biosciences FDA EventsEdesa Biotech FDA EventsEupraxia Pharmaceuticals FDA EventsImmunocore FDA EventsInsmed 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 Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:VOGX last updated on 10/16/2026 by MarketBeat.com Staff. 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Initiation - October 15,2026Initiation Drug: VGX-001-013Announced Date: October 15, 2026Indication: for Post-Bariatric HypoglycemiaAnnouncementVogenx, Inc. announced the initiation of EMERGE (VGX-001-013), its Phase 2b clinical trial evaluating mizagliflozin for the treatment of post-bariatric hypoglycemia (PBH).Read Announcement
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