Burning Rock Biotech (BNR) FDA Approvals $9.45 -0.74 (-7.26%) As of 03:59 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsInsider TradesNews and TrendsOwnershipSEC FilingsShort Interest 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 Axsome Therapeutics FDA EventsBioVie FDA EventsEnsysce Biosciences FDA EventsIDEAYA Biosciences FDA EventsJazz Pharmaceuticals FDA EventsKaryopharm Therapeutics FDA EventsBeyond Air FDA EventsEli Lilly and Company FDA EventsAlnylam Pharmaceuticals FDA EventsArrowhead Pharmaceuticals FDA EventsBridgeBio Pharma FDA EventsCytokinetics FDA EventsTenax Therapeutics FDA EventsBristol Myers Squibb FDA EventsAmarin 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 Compass Therapeutics FDA Events PureTech Health FDA Events Larimar Therapeutics FDA Events Foghorn Therapeutics FDA Events Arcturus Therapeutics FDA Events X4 Pharmaceuticals FDA Events Capricor Therapeutics FDA Events Rocket Pharmaceuticals FDA Events Century Therapeutics FDA Events Upstream Bio FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:BNR last updated on 9/24/2025 by MarketBeat.com Staff. 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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
