Freenome (FRNM) FDA Approvals $11.56 -0.05 (-0.43%) As of 08/14/2026 04:00 PM Eastern Add Share Share FDA Events Stock AnalysisAnalyst ForecastsChartFDA EventsSEC FilingsTrendsBuy This Stock Freenome's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Freenome (FRNM). Over the past two years, Freenome has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SimpleScreen™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. SimpleScreen™ FDA Regulatory Events SimpleScreen™ is a drug developed by Freenome for the following indication: Lung Cancer Screening Test. 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. Designation Grant - August 12,2026Designation Grant Breakthrough DeviceDrug: SimpleScreen™Announced Date: August 12, 2026Indication: Lung Cancer Screening TestAnnouncementFreenome, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to SimpleScreen™ Lung, the company’s investigational lung cancer screening test.Read Announcement Freenome FDA Events - Frequently Asked Questions Has Freenome received FDA approval? As of now, Freenome (FRNM) has not received any FDA approvals for its therapy in the last two years. What drugs has Freenome submitted to the FDA? In the past two years, Freenome (FRNM) has reported FDA regulatory activity for SimpleScreen™. What is the most recent FDA event for Freenome? The most recent FDA-related event for Freenome occurred on August 12, 2026, involving SimpleScreen™. The update was categorized as "Designation Grant," with the company reporting: "Freenome, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to SimpleScreen™ Lung, the company’s investigational lung cancer screening test." What conditions do Freenome's current drugs treat? Currently, Freenome has one therapy (SimpleScreen™) targeting the following condition: Lung Cancer Screening Test. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Fate Therapeutics FDA EventsLantheus FDA EventsAgenus FDA EventsBiomea Fusion FDA EventsMiNK Therapeutics FDA EventsRigel Pharmaceuticals FDA EventsBristol Myers Squibb FDA EventsAligos Therapeutics FDA EventsAnnexon FDA EventsAlterity Therapeutics FDA EventsCullinan Therapeutics FDA EventsDefinium Therapeutics FDA EventsFreenome FDA EventsAthira Pharma FDA EventsNeurocrine Biosciences 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 Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:FRNM last updated on 8/12/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersThey didn't warn anyone in 1971. This time someone is warning you.On August 15, 1971, Nixon interrupted prime-time television and ended the gold standard in 15 minutes - no deb...Reagan Gold Group | SponsoredHere’s the stock symbol I’ve promisedWhitney Tilson of Stansberry Research has long recommended Berkshire Hathaway as a core retirement holding - b...Stansberry Research | SponsoredYour 10X AI demo is starting…Keith Kaplan, the AI expert behind tools used by more than 100000 investors, built his models with an investme...TradeSmith | SponsoredRay Dalio: Buy Gold. Get Paid.Ray Dalio, founder of Bridgewater Associates, is urging investors to hold 15% of their portfolio in gold and c...Investors Alley | SponsoredWhy acquisitions are reshaping the gold mining sector right nowGold major acquisitions have repriced junior miners overnight, with past deals delivering gains from 40% to 1,...Golden Portfolio | SponsoredWall Street is staring at the wrong AI tradeAnthropic just signed a 9.1 billion dollar, 20 year data center agreement covering 191 megawatts of capacity, ...The Oxford Club | SponsoredYour book is insideThe "Sucker's Bet" Most New Options Traders Fall For Most people who try options lose money the same way. ...Profits Run | SponsoredWhat is Trump’s decade-long obsession?No president has moved markets like Trump, adding and erasing trillions in value seemingly at will. Analyst...Brownstone Research | 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 Freenome Please log in to your account or sign up in order to add this asset to your watchlist. Share Freenome 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.
Designation Grant - August 12,2026Designation Grant Breakthrough DeviceDrug: SimpleScreen™Announced Date: August 12, 2026Indication: Lung Cancer Screening TestAnnouncementFreenome, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to SimpleScreen™ Lung, the company’s investigational lung cancer screening test.Read Announcement
