Aclarion (ACON) FDA Approvals $2.60 +0.06 (+2.36%) Closing price 09/11/2026 04:00 PM EasternExtended Trading$2.62 +0.02 (+0.58%) As of 09/11/2026 07:30 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 EventsInsider TradesNews and TrendsSEC Filings Aclarion's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Aclarion (ACON). Over the past two years, Aclarion has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CLARITY. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. CLARITY FDA Regulatory Events CLARITY is a drug developed by Aclarion for the following indication: Chronic Low bAck pain. 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. Enrollment Update - September 25,2025Enrollment Update Drug: CLARITYAnnounced Date: September 25, 2025Indication: Chronic Low bAck pain AnnouncementAclarion, Inc., announced that the UHealth – University of Miami Health System and the Miller School of Medicine enrolled its first two patients in the CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial. The pivotal CLARITY study is designed to demonstrate Nociscan's clinical and economic value in spine surgery.AI SummaryAclarion, Inc. announced that the UHealth – University of Miami Health System and the Miller School of Medicine enrolled the first two patients in the CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial. This study will test whether Nociscan can improve outcomes for people having spine surgery for chronic low back pain. The CLARITY trial will enroll 300 patients at leading U.S. centers and randomly assign surgeons to use Nociscan data or not. All participants receive an MRS scan before treatment. The main goal is to measure back pain change after 12 months, with other health and cost measures tracked as secondary endpoints. Internal interim results are expected in Q2 2026. Nociscan combines MR Spectroscopy and augmented intelligence to detect chemical biomarkers linked to disc pain. Aclarion hopes this tool will become the gold standard for identifying pain sources, improve surgical planning, and demonstrate both clinical and economic value in spine surgery.Read Announcement Aclarion FDA Events - Frequently Asked Questions Has Aclarion received FDA approval? As of now, Aclarion (ACON) has not received any FDA approvals for its therapy in the last two years. What drugs has Aclarion submitted to the FDA? In the past two years, Aclarion (ACON) has reported FDA regulatory activity for CLARITY. What is the most recent FDA event for Aclarion? The most recent FDA-related event for Aclarion occurred on September 25, 2025, involving CLARITY. The update was categorized as "Enrollment Update," with the company reporting: "Aclarion, Inc., announced that the UHealth – University of Miami Health System and the Miller School of Medicine enrolled its first two patients in the CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial. The pivotal CLARITY study is designed to demonstrate Nociscan's clinical and economic value in spine surgery." What conditions do Aclarion's current drugs treat? Currently, Aclarion has one therapy (CLARITY) targeting the following condition: Chronic Low bAck pain. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Agenus FDA EventsBioLineRx FDA EventsCAMP4 Therapeutics FDA EventsCompass Pathways FDA EventsJaguar Animal Health FDA EventsLegend Biotech FDA EventsLyell Immunopharma FDA EventsMedicus Pharma FDA EventsOncolytics Biotech FDA EventsOptimi Health FDA EventsOncobiologics FDA EventsPrelude Therapeutics FDA EventsVerrica Pharmaceuticals FDA EventsAbbVie FDA EventsAscendis Pharma A/S 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 Heartflow FDA Events GoodRx FDA Events TScan Therapeutics FDA Events Tvardi Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:ACON last updated on 9/25/2025 by MarketBeat.com Staff. 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Enrollment Update - September 25,2025Enrollment Update Drug: CLARITYAnnounced Date: September 25, 2025Indication: Chronic Low bAck pain AnnouncementAclarion, Inc., announced that the UHealth – University of Miami Health System and the Miller School of Medicine enrolled its first two patients in the CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial. The pivotal CLARITY study is designed to demonstrate Nociscan's clinical and economic value in spine surgery.AI SummaryAclarion, Inc. announced that the UHealth – University of Miami Health System and the Miller School of Medicine enrolled the first two patients in the CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial. This study will test whether Nociscan can improve outcomes for people having spine surgery for chronic low back pain. The CLARITY trial will enroll 300 patients at leading U.S. centers and randomly assign surgeons to use Nociscan data or not. All participants receive an MRS scan before treatment. The main goal is to measure back pain change after 12 months, with other health and cost measures tracked as secondary endpoints. Internal interim results are expected in Q2 2026. Nociscan combines MR Spectroscopy and augmented intelligence to detect chemical biomarkers linked to disc pain. Aclarion hopes this tool will become the gold standard for identifying pain sources, improve surgical planning, and demonstrate both clinical and economic value in spine surgery.Read Announcement
