Burning Rock Biotech (BNR) FDA Approvals $8.33 +0.15 (+1.83%) Closing price 06/10/2026 03:59 PM EasternExtended Trading$8.38 +0.04 (+0.54%) As of 06/10/2026 04:04 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Burning Rock Biotech's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Burning Rock Biotech (BNR). Over the past two years, Burning Rock Biotech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Capivasertib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Capivasertib FDA Regulatory Events Capivasertib is a drug developed by Burning Rock Biotech for the following indication: in Breast Cancer. 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. Approved - September 24,2025Approved MHLW ApprovalDrug: CapivasertibAnnounced Date: September 24, 2025Indication: in Breast CancerAnnouncementRiken Genesis Co., Ltd. and Burning Rock Biotech Limited announced that the OncoGuide™ OncoScreen™ Plus CDx System based on OncoScreen™ Plus to be used as a companion diagnostic for AstraZeneca's capivasertib has received Manufacturing and Marketing Approval from Japan's Ministry of Health, Labour and Welfare (MHLW).AI SummaryRiken Genesis Co., Ltd. and Burning Rock Biotech Limited announced that their OncoGuide™ OncoScreen™ Plus CDx System has received Manufacturing and Marketing Approval from Japan’s Ministry of Health, Labour and Welfare. This new companion diagnostic will guide the use of AstraZeneca’s capivasertib in combination with fulvestrant. The CDx System uses next-generation sequencing to detect PIK3CA, AKT1, and PTEN gene changes from tumor tissue in a single test. It is designed for adult patients with unresectable or recurrent hormone-receptor-positive, HER2-negative breast cancer whose disease has progressed after endocrine therapy. By helping doctors select patients whose tumors carry relevant genetic alterations, this tool aims to improve treatment decisions and patient outcomes. Riken Genesis will work on securing insurance coverage to ensure timely access across Japan. Both companies plan to expand registration efforts in other markets, seeking broader patient benefits from this precision diagnostic technology.Read Announcement Burning Rock Biotech FDA Events - Frequently Asked Questions Has Burning Rock Biotech received FDA approval? As of now, Burning Rock Biotech (BNR) has not received any FDA approvals for its therapy in the last two years. What drugs has Burning Rock Biotech submitted to the FDA? In the past two years, Burning Rock Biotech (BNR) has reported FDA regulatory activity for Capivasertib. What is the most recent FDA event for Burning Rock Biotech? The most recent FDA-related event for Burning Rock Biotech occurred on September 24, 2025, involving Capivasertib. The update was categorized as "Approved," with the company reporting: "Riken Genesis Co., Ltd. and Burning Rock Biotech Limited announced that the OncoGuide™ OncoScreen™ Plus CDx System based on OncoScreen™ Plus to be used as a companion diagnostic for AstraZeneca's capivasertib has received Manufacturing and Marketing Approval from Japan's Ministry of Health, Labour and Welfare (MHLW)." What conditions do Burning Rock Biotech's current drugs treat? Currently, Burning Rock Biotech has one therapy (Capivasertib) targeting the following condition: in Breast Cancer. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Harrow FDA EventsOrganon & Co. FDA EventsActuate Therapeutics FDA EventsAlterity Therapeutics FDA EventsErnexa Therapeutics FDA EventsKymera Therapeutics FDA EventsMicrobot Medical FDA EventsPalisade Bio FDA EventsRedhill Biopharma FDA EventsScienture FDA EventsTG Therapeutics FDA EventsGenmab A/S FDA EventsMediciNova FDA EventsMetaVia 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 Related Companies Aclarion FDA Events Natera FDA Events Guardant Health FDA Events Celcuity FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:BNR last updated on 9/24/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersJune 12: $100 Turns Into $100,000?The SpaceX IPO is scheduled for June 12, and former tech executive Jeff Brown - who identified Bitcoin, Tesla,...Brownstone Research | Sponsored$30 stock to buy before Starlink goes public (WATCH NOW!)In the next 3 minutes… James Altucher – legendary investor and venture capitalist… And someone who’s kno...Paradigm Press | SponsoredTrump's gold order: the announcement they won't put on the front pageOn August 15, 1971, Nixon interrupted prime-time television and ended the gold standard in 15 minutes - no deb...Reagan Gold Group | SponsoredLouis Navellier: My #1 AI stock for 2026 (name & ticker inside)Louis Navellier's Stock Grader system helped him flag Nvidia before its 82,000% run and has identified the top...InvestorPlace | SponsoredYour book attachedYour Download Link (Expiring) If you still haven't downloaded the free Simple Options Trading For Beginners...Profits Run | SponsoredSpaceX just filed. The clock is ticking.Reuters reports Elon Musk filed secretly. Barron's says it's being finalized behind closed doors. CNBC just re...The Oxford Club | SponsoredMy feud with Zohran MamdaniEmmy-winning analyst releases his next big story Whitney Tilson shocked the nation on 60 Minutes when he ac...Stansberry Research | SponsoredWhy this tiny stock may move before the SpaceX IPO dropsThe projected SpaceX and xAI S-1 filing hits the SEC on June 1st - and analyst Dylan Jovine says $1.75 trillio...Behind the Markets | 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 Burning Rock Biotech Limited Sponsored ADR Please log in to your account or sign up in order to add this asset to your watchlist. Share Burning Rock Biotech 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 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.
Approved - September 24,2025Approved MHLW ApprovalDrug: CapivasertibAnnounced Date: September 24, 2025Indication: in Breast CancerAnnouncementRiken Genesis Co., Ltd. and Burning Rock Biotech Limited announced that the OncoGuide™ OncoScreen™ Plus CDx System based on OncoScreen™ Plus to be used as a companion diagnostic for AstraZeneca's capivasertib has received Manufacturing and Marketing Approval from Japan's Ministry of Health, Labour and Welfare (MHLW).AI SummaryRiken Genesis Co., Ltd. and Burning Rock Biotech Limited announced that their OncoGuide™ OncoScreen™ Plus CDx System has received Manufacturing and Marketing Approval from Japan’s Ministry of Health, Labour and Welfare. This new companion diagnostic will guide the use of AstraZeneca’s capivasertib in combination with fulvestrant. The CDx System uses next-generation sequencing to detect PIK3CA, AKT1, and PTEN gene changes from tumor tissue in a single test. It is designed for adult patients with unresectable or recurrent hormone-receptor-positive, HER2-negative breast cancer whose disease has progressed after endocrine therapy. By helping doctors select patients whose tumors carry relevant genetic alterations, this tool aims to improve treatment decisions and patient outcomes. Riken Genesis will work on securing insurance coverage to ensure timely access across Japan. Both companies plan to expand registration efforts in other markets, seeking broader patient benefits from this precision diagnostic technology.Read Announcement
Free BNR Stock Alerts