Co-Diagnostics (CODX) FDA Approvals $1.10 -0.03 (-2.23%) As of 11:15 AM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsNews and TrendsOwnershipSEC Filings Co-Diagnostics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Co-Diagnostics (CODX). Over the past two years, Co-Diagnostics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Co-Dx™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Co-Dx™ FDA Regulatory Events Co-Dx™ is a drug developed by Co-Diagnostics for the following indication: PCR COVID-19 test instrument. 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 - June 2,2026Provided Update Drug: Co-Dx™Announced Date: June 2, 2026Indication: PCR COVID-19 test instrument AnnouncementCo-Diagnostics, Inc. announced continued progress in its Ebola PCR development program with joint venture CoSara Diagnostics Pvt. Ltd. ("CoSara" or the "JV").AI SummaryCo-Diagnostics, Inc. said its joint venture, CoSara Diagnostics Pvt. Ltd., is making steady progress on an Ebola PCR development program. The company is working on a dual-assay strategy that could help both outbreak response and ongoing surveillance in affected regions. One possible test would use blood samples, which could expand the capabilities of Co-Dx’s PCR point-of-care platform. Co-Diagnostics said this approach may offer more flexibility for public health response efforts, including support for potential non-governmental organization partners. The project is still in development and will need validation, regulatory review, and future deployment steps before it can be used. The company said the effort is meant to improve readiness for Ebola response in areas that may need fast and reliable testing.Read Announcement Co-Diagnostics FDA Events - Frequently Asked Questions Has Co-Diagnostics received FDA approval? As of now, Co-Diagnostics (CODX) has not received any FDA approvals for its therapy in the last two years. What drugs has Co-Diagnostics submitted to the FDA? In the past two years, Co-Diagnostics (CODX) has reported FDA regulatory activity for Co-Dx™. What is the most recent FDA event for Co-Diagnostics? The most recent FDA-related event for Co-Diagnostics occurred on June 2, 2026, involving Co-Dx™. The update was categorized as "Provided Update," with the company reporting: "Co-Diagnostics, Inc. announced continued progress in its Ebola PCR development program with joint venture CoSara Diagnostics Pvt. Ltd. ("CoSara" or the "JV")." What conditions do Co-Diagnostics' current drugs treat? Currently, Co-Diagnostics has one therapy (Co-Dx™) targeting the following condition: PCR COVID-19 test instrument. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Addex Therapeutics FDA EventsAclarion FDA EventsEditas Medicine FDA EventsEntera Bio FDA EventsEdgewise Therapeutics FDA EventsPhathom Pharmaceuticals FDA EventsTG Therapeutics FDA EventsBristol Myers Squibb FDA EventsArvinas FDA EventsArrowhead Pharmaceuticals FDA EventsBioCardia FDA EventsImmunic FDA EventsKura Oncology FDA EventsLakewood-Amedex Biotherapeutics FDA EventsLipocine 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 Context Therapeutics FDA Events Radiopharm Theranostics FDA Events TScan Therapeutics FDA Events Jasper Therapeutics FDA Events Estrella Immunopharma FDA Events Atossa Genetics FDA Events Neuphoria Therapeutics FDA Events Akari Therapeutics FDA Events NextCure FDA Events NLS Pharmaceutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:CODX last updated on 6/2/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersHOST Just Entered the AI Data Center Race in a BIG WayHost Digital Inc (NYSE American: HOST) has completed its merger with Healthy Choice Wellness Corp as of Septem...Trading Wire | SponsoredOminous New Day in America (Get Ready for it)A market forecaster with a 55-year track record - including calls on 1970s double-digit inflation, the 1980s S...Weiss Ratings | Sponsored$169 Private Jet Trick ExposedFor $169, a growing circle of travelers are booking private jets without the wait, the hassle, or the high pri...International Living | SponsoredWhy The Biggest Names in AI Are Heading To The ArcticGoogle contracted over 12 GW of energy last year and just announced a 15 billion dollar AI infrastructure inve...The Tomorrow Investor | SponsoredThese gold assets are priced for $1,800 gold [it's over $4,000]Gold's major miners are generating record free cash flow, with margins as high as 75 percent even after gold's...Golden Portfolio | SponsoredHere’s Why Trump Won’t End The Iran WarTrump has called an Iran deal close 38 times since the war began, yet the fighting keeps flaring back up. O...Banyan Hill Publishing | SponsoredMy top 3 AI picks for the next decadeAlexander Green bought Apple in 1996, recommended Nvidia at a split-adjusted 66 cents in 2004, and picked up A...The Oxford Club | SponsoredCODE RED: AI Meltdown Imminent?After correctly predicting the 2008 and 2020 stock market meltdowns, I believe this AI company is about to tri...Paradigm Press | 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 Co-Diagnostics, Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share Co-Diagnostics With A Colleague Link copied to clipboard. Unlock superior investment research and tools. Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools and reports. Get MarketBeat All Access 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 Email Me a Login Link 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.
Provided Update - June 2,2026Provided Update Drug: Co-Dx™Announced Date: June 2, 2026Indication: PCR COVID-19 test instrument AnnouncementCo-Diagnostics, Inc. announced continued progress in its Ebola PCR development program with joint venture CoSara Diagnostics Pvt. Ltd. ("CoSara" or the "JV").AI SummaryCo-Diagnostics, Inc. said its joint venture, CoSara Diagnostics Pvt. Ltd., is making steady progress on an Ebola PCR development program. The company is working on a dual-assay strategy that could help both outbreak response and ongoing surveillance in affected regions. One possible test would use blood samples, which could expand the capabilities of Co-Dx’s PCR point-of-care platform. Co-Diagnostics said this approach may offer more flexibility for public health response efforts, including support for potential non-governmental organization partners. The project is still in development and will need validation, regulatory review, and future deployment steps before it can be used. The company said the effort is meant to improve readiness for Ebola response in areas that may need fast and reliable testing.Read Announcement
