GeoVax Labs (GOVX) FDA Events $0.73 0.00 (-0.53%) As of 04:00 PM Eastern 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 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 Lantern Pharma FDA Events Mersana Therapeutics FDA Events Medicus Pharma FDA Events Karyopharm Therapeutics FDA Events Alterity Therapeutics FDA Events Rani Therapeutics FDA Events Iterum Therapeutics FDA Events Shattuck Labs FDA Events LAVA Therapeutics FDA Events Xilio Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA Events Tools Recent FDA Drug Approval Process Events This page (NASDAQ:GOVX) was last updated on 7/17/2025 by MarketBeat.com Staff From Our PartnersINVESTOR ALERT: Tiny “$3 AI Wonder Stock” on the Verge of Blasting OffRight now, we’re witnessing a monumental shift in the world.Traders Agency | SponsoredMarket Panic: Trump Just Dropped a Bomb on Your Stockstock Market Panic: Trump Just Dropped a Bomb on Your Stocks The market is in freefall—and Trump's new tarif...American Alternative | SponsoredThis Signal Only Flashes Once Every 4 Years – And It Just TriggeredThis same signal has appeared twice before in the past 8 years — both times, it kicked off major moves in cryp...Crypto Swap Profits | SponsoredPresidential Bombshell: $150T Resource to Be Released as soon as this Summer?Something extraordinary is happening in Washington. For the first time in over a century, a sitting Preside...Paradigm Press | Sponsored[No Brainer Gold Play]: “Show me a better investment.”A Historic Gold Announcement Is About to Rock Wall Street? For months, sharp-eyed analysts have watched the...Golden Portfolio | SponsoredGoogle did what!?!?A new technology has sparked a modern-day gold rush in Silicon Valley. OpenAI’s Sam Altman invested $375M. Bil...Stansberry Research | SponsoredTurn $1K into $50K with This DeFi GemI've never been more confident about a DeFi opportunity. This isn't about complex trading or risky bets. Th...Crypto 101 Media | SponsoredThe Robotics Revolution has arrived … and one $7 stock could take off as a result.Something big is brewing in Washington. According to my research, an executive order from President Trump c...Weiss Ratings | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding GeoVax Labs Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share GeoVax Labs With A Colleague Link copied to clipboard. Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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