GeoVax Labs (GOVX) FDA Approvals $1.19 -0.03 (-2.13%) As of 03:08 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock GeoVax Labs' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by GeoVax Labs (GOVX). Over the past two years, GeoVax Labs has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as GEO-CM04S1. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. GEO-CM04S1 FDA Regulatory Events GEO-CM04S1 is a drug developed by GeoVax Labs for the following indication: For CLL Patients. 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 Presentation - June 17,2025Data Presentation Drug: GEO-CM04S1Announced Date: June 17, 2025Indication: For CLL PatientsAnnouncementGeoVax Labs, Inc. today highlighted new clinical data presented at the 2025 European Hematology Association (EHA) Hybrid Congress which took place June 12-15 in Milan, Italy.Read Announcement GeoVax Labs FDA Events - Frequently Asked Questions Has GeoVax Labs received FDA approval? As of now, GeoVax Labs (GOVX) has not received any FDA approvals for its therapy in the last two years. What drugs has GeoVax Labs submitted to the FDA? In the past two years, GeoVax Labs (GOVX) has reported FDA regulatory activity for GEO-CM04S1. What is the most recent FDA event for GeoVax Labs? The most recent FDA-related event for GeoVax Labs occurred on June 17, 2025, involving GEO-CM04S1. The update was categorized as "Data Presentation," with the company reporting: "GeoVax Labs, Inc. today highlighted new clinical data presented at the 2025 European Hematology Association (EHA) Hybrid Congress which took place June 12-15 in Milan, Italy." What conditions do GeoVax Labs' current drugs treat? Currently, GeoVax Labs has one therapy (GEO-CM04S1) targeting the following condition: For CLL Patients. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Entera Bio FDA EventsHumacyte FDA EventsInhibrx Biosciences FDA EventsMedicus Pharma FDA EventsNeurocrine Biosciences FDA EventsPrecigen FDA EventsElanco Animal Health FDA EventsBioCryst Pharmaceuticals FDA EventsCogent Biosciences FDA EventsJazz Pharmaceuticals FDA EventsKymera Therapeutics FDA EventsAbbVie FDA EventsAC Immune FDA EventsAscendis Pharma A/S FDA EventsC4 Therapeutics 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 VYNE Therapeutics FDA Events VistaGen Therapeutics FDA Events Cellectar Biosciences FDA Events Mainz Biomed FDA Events Medicus Pharma FDA Events Sensei Biotherapeutics FDA Events Werewolf Therapeutics FDA Events Tempest Therapeutics FDA Events Exicure FDA Events Novogen FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:GOVX last updated on 6/19/2025 by MarketBeat.com Staff. 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Data Presentation - June 17,2025Data Presentation Drug: GEO-CM04S1Announced Date: June 17, 2025Indication: For CLL PatientsAnnouncementGeoVax Labs, Inc. today highlighted new clinical data presented at the 2025 European Hematology Association (EHA) Hybrid Congress which took place June 12-15 in Milan, Italy.Read Announcement
