First Tracks Biotherapeutics (TRAX) FDA Approvals $31.85 0.00 (0.00%) Closing price 10/9/2026 04:00 PM EasternExtended Trading$37.49 +5.65 (+17.72%) As of 05:12 AM 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 EventsInsider TradesNews and TrendsOwnershipSEC FilingsShort Interest First Tracks Biotherapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by First Tracks Biotherapeutics (TRAX). Over the past two years, First Tracks Biotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ANB033. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. ANB033 FDA Regulatory Events ANB033 is a drug developed by First Tracks Biotherapeutics for the following indication: in Celiac Disease. 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. Provided Update - October 11,2026Provided Update Drug: ANB033Announced Date: October 11, 2026Indication: in Celiac DiseaseAnnouncementFirst Tracks Biotherapeutics, Inc. will host an investor call and live webcast to review top-line data from Cohort 1, a gluten-challenge study assessing prevention of mucosal damage, of the global Phase 1b trial of investigational ANB033, a CD122 antagonist, in celiac disease on Monday, Oct. 12, 2026, at 8:30am ET/5:30am PT.Read Announcement First Tracks Biotherapeutics FDA Events - Frequently Asked Questions Has First Tracks Biotherapeutics received FDA approval? As of now, First Tracks Biotherapeutics (TRAX) has not received any FDA approvals for its therapy in the last two years. What drugs has First Tracks Biotherapeutics submitted to the FDA? In the past two years, First Tracks Biotherapeutics (TRAX) has reported FDA regulatory activity for ANB033. What is the most recent FDA event for First Tracks Biotherapeutics? The most recent FDA-related event for First Tracks Biotherapeutics occurred on October 11, 2026, involving ANB033. The update was categorized as "Provided Update," with the company reporting: "First Tracks Biotherapeutics, Inc. will host an investor call and live webcast to review top-line data from Cohort 1, a gluten-challenge study assessing prevention of mucosal damage, of the global Phase 1b trial of investigational ANB033, a CD122 antagonist, in celiac disease on Monday, Oct. 12, 2026, at 8:30am ET/5:30am PT." What conditions do First Tracks Biotherapeutics' current drugs treat? Currently, First Tracks Biotherapeutics has one therapy (ANB033) targeting the following condition: in Celiac Disease. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events BridgeBio Pharma FDA EventsMirum Pharmaceuticals FDA EventsFirst Tracks Biotherapeutics FDA EventsAbbVie FDA EventsLB Pharmaceuticals FDA EventsMerck & Co., Inc. FDA EventsAlumis 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 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 Edgewise Therapeutics FDA Events Relay Therapeutics FDA Events Tango Therapeutics FDA Events AbCellera Biologics FDA Events Legend Biotech FDA Events Veracyte FDA Events Viking Therapeutics FDA Events Xenon Pharmaceuticals FDA Events ACADIA Pharmaceuticals FDA Events Celcuity FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:TRAX last updated on 10/12/2026 by MarketBeat.com Staff. 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Provided Update - October 11,2026Provided Update Drug: ANB033Announced Date: October 11, 2026Indication: in Celiac DiseaseAnnouncementFirst Tracks Biotherapeutics, Inc. will host an investor call and live webcast to review top-line data from Cohort 1, a gluten-challenge study assessing prevention of mucosal damage, of the global Phase 1b trial of investigational ANB033, a CD122 antagonist, in celiac disease on Monday, Oct. 12, 2026, at 8:30am ET/5:30am PT.Read Announcement
