Virax Biolabs Group (VRAX) FDA Approvals $0.23 -0.05 (-18.20%) As of 04:00 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesSEC FilingsShort InterestTrendsBuy This Stock Virax Biolabs Group's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Virax Biolabs Group (VRAX). Over the past two years, Virax Biolabs Group has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ViraxImmune. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. ViraxImmune FDA Regulatory Events ViraxImmune is a drug developed by Virax Biolabs Group for the following indication: Long COVID and Related Post-Acute Infection Syndromes. 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. Positive Data - May 26,2026Positive Data Drug: ViraxImmuneAnnounced Date: May 26, 2026Indication: Long COVID and Related Post-Acute Infection SyndromesAnnouncementVirax Biolabs Group Limited today reported positive early pilot performance data for ViraxImmune™, its blood-based test in development for Long COVID, myalgic encephalomyelitis/chronic fatigue syndrome ("ME/CFS") and related post-acute infection syndromes ("PAIS").AI SummaryVirax Biolabs Group Limited said early pilot data for ViraxImmune™, its blood-based test under development for Long COVID, ME/CFS, and related post-acute infection syndromes, showed positive signs. The company said the results are from the VRX003 study and are still very early, so they should be seen as preliminary. Virax said the findings will help guide ongoing test development and plans for future clinical validation. ViraxImmune™ is not approved for diagnostic use in any country. The company is working on T cell-based testing tools that may help measure immune responses and support a broader immunology profiling platform. Virax said these types of tests could have uses in conditions tied to immune system problems, including Long COVID and other chronic illnesses.Read Announcement Virax Biolabs Group FDA Events - Frequently Asked Questions Has Virax Biolabs Group received FDA approval? As of now, Virax Biolabs Group (VRAX) has not received any FDA approvals for its therapy in the last two years. What drugs has Virax Biolabs Group submitted to the FDA? In the past two years, Virax Biolabs Group (VRAX) has reported FDA regulatory activity for ViraxImmune. What is the most recent FDA event for Virax Biolabs Group? The most recent FDA-related event for Virax Biolabs Group occurred on May 26, 2026, involving ViraxImmune. The update was categorized as "Positive Data," with the company reporting: "Virax Biolabs Group Limited today reported positive early pilot performance data for ViraxImmune™, its blood-based test in development for Long COVID, myalgic encephalomyelitis/chronic fatigue syndrome ("ME/CFS") and related post-acute infection syndromes ("PAIS")." What conditions do Virax Biolabs Group's current drugs treat? Currently, Virax Biolabs Group has one therapy (ViraxImmune) targeting the following condition: Long COVID and Related Post-Acute Infection Syndromes. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Axsome Therapeutics FDA EventsBriacell Therap FDA EventsBioVie FDA EventsCullinan Therapeutics FDA EventsClimb Bio FDA EventsCorbus Pharmaceuticals FDA EventsDyne Therapeutics FDA EventsEditas Medicine FDA EventsEsperion Therapeutics FDA EventsGain Therapeutics FDA EventsJade Biosciences FDA EventsKura Oncology FDA EventsNovogen FDA EventsOlema Pharmaceuticals FDA EventsPainReform 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 InMed Pharmaceuticals FDA Events Reviva Pharmaceuticals FDA Events Mustang Bio FDA Events Redhill Biopharma FDA Events Dermata Therapeutics FDA Events Purple Biotech FDA Events Adial Pharmaceuticals FDA Events Akari Therapeutics FDA Events Revelation Biosciences FDA Events Psyence Biomedical FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:VRAX last updated on 5/26/2026 by MarketBeat.com Staff. 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Positive Data - May 26,2026Positive Data Drug: ViraxImmuneAnnounced Date: May 26, 2026Indication: Long COVID and Related Post-Acute Infection SyndromesAnnouncementVirax Biolabs Group Limited today reported positive early pilot performance data for ViraxImmune™, its blood-based test in development for Long COVID, myalgic encephalomyelitis/chronic fatigue syndrome ("ME/CFS") and related post-acute infection syndromes ("PAIS").AI SummaryVirax Biolabs Group Limited said early pilot data for ViraxImmune™, its blood-based test under development for Long COVID, ME/CFS, and related post-acute infection syndromes, showed positive signs. The company said the results are from the VRX003 study and are still very early, so they should be seen as preliminary. Virax said the findings will help guide ongoing test development and plans for future clinical validation. ViraxImmune™ is not approved for diagnostic use in any country. The company is working on T cell-based testing tools that may help measure immune responses and support a broader immunology profiling platform. Virax said these types of tests could have uses in conditions tied to immune system problems, including Long COVID and other chronic illnesses.Read Announcement
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