Quanterix (QTRX) FDA Approvals $2.64 +0.12 (+4.76%) Closing price 04:00 PM EasternExtended Trading$2.66 +0.02 (+0.76%) As of 04:10 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 TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Quanterix's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Quanterix (QTRX). Over the past two years, Quanterix has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Simoa. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Simoa p-Tau 217 FDA Regulatory Events Simoa p-Tau 217 is a drug developed by Quanterix for the following indication: Redefining Alzheimer's Disease Neuropathology Prevalence. 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. Publication - December 22,2025Publication Drug: Simoa p-Tau 217Announced Date: December 22, 2025Indication: Redefining Alzheimer's Disease Neuropathology PrevalenceAnnouncementQuanterix Corporation announced publication of a landmark study in the prestigious journal Nature.AI SummaryQuanterix Corporation announced publication of a landmark study in Nature that used its ultra‑sensitive Simoa p‑Tau 217 (phosphorylated tau at threonine 217) research assay to perform the largest population‑based assessment of Alzheimer’s disease neuropathology to date. Researchers analyzed more than 11,000 Norwegian adults aged 58 and older and found AD neuropathological change (ADNC) rises sharply with age — about 10% in ages 58–69.9 and 64.9% in those over 90. Among people 70 and older, 30.4% showed ADNC: 11.4% preclinical AD, 10.8% prodromal AD, and 7.4% AD dementia. The study also estimates roughly 10% of the 70+ population meet current treatment eligibility and links AD pathology to sex, APOE genotype, and education. The findings relied on a validated commercial p‑Tau 217 kit (ALZpath p‑Tau‑217 Advantage PLUS) run on a fully automated HD‑X analyzer. Quanterix says its Simoa platform enabled scalable, sensitive blood measurements that make population‑level screening and planning for treatments and trials more feasible.Read Announcement Quanterix FDA Events - Frequently Asked Questions Has Quanterix received FDA approval? As of now, Quanterix (QTRX) has not received any FDA approvals for its therapy in the last two years. What drugs has Quanterix submitted to the FDA? In the past two years, Quanterix (QTRX) has reported FDA regulatory activity for Simoa p-Tau 217. What is the most recent FDA event for Quanterix? The most recent FDA-related event for Quanterix occurred on December 22, 2025, involving Simoa p-Tau 217. The update was categorized as "Publication," with the company reporting: "Quanterix Corporation announced publication of a landmark study in the prestigious journal Nature." What conditions do Quanterix's current drugs treat? Currently, Quanterix has one therapy (Simoa p-Tau 217) targeting the following condition: Redefining Alzheimer's Disease Neuropathology Prevalence. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Adagio Medical FDA EventsBioCardia FDA EventsCognition Therapeutics FDA EventsCorbus Pharmaceuticals FDA EventsPrecision BioSciences FDA EventsHUTCHMED FDA EventsEli Lilly and Company FDA EventsTeleflex FDA EventsBioMarin Pharmaceutical FDA EventsDiaMedica Therapeutics FDA EventsDyne Therapeutics FDA EventsGuardant Health FDA EventsLigand Pharmaceuticals FDA EventsMadrigal Pharmaceuticals FDA EventsMetaVia 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 Revvity FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:QTRX last updated on 12/22/2025 by MarketBeat.com Staff. 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Publication - December 22,2025Publication Drug: Simoa p-Tau 217Announced Date: December 22, 2025Indication: Redefining Alzheimer's Disease Neuropathology PrevalenceAnnouncementQuanterix Corporation announced publication of a landmark study in the prestigious journal Nature.AI SummaryQuanterix Corporation announced publication of a landmark study in Nature that used its ultra‑sensitive Simoa p‑Tau 217 (phosphorylated tau at threonine 217) research assay to perform the largest population‑based assessment of Alzheimer’s disease neuropathology to date. Researchers analyzed more than 11,000 Norwegian adults aged 58 and older and found AD neuropathological change (ADNC) rises sharply with age — about 10% in ages 58–69.9 and 64.9% in those over 90. Among people 70 and older, 30.4% showed ADNC: 11.4% preclinical AD, 10.8% prodromal AD, and 7.4% AD dementia. The study also estimates roughly 10% of the 70+ population meet current treatment eligibility and links AD pathology to sex, APOE genotype, and education. The findings relied on a validated commercial p‑Tau 217 kit (ALZpath p‑Tau‑217 Advantage PLUS) run on a fully automated HD‑X analyzer. Quanterix says its Simoa platform enabled scalable, sensitive blood measurements that make population‑level screening and planning for treatments and trials more feasible.Read Announcement
