ClearPoint Neuro (CLPT) FDA Approvals $14.67 +0.14 (+0.96%) As of 09:44 AM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock ClearPoint Neuro's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by ClearPoint Neuro (CLPT). Over the past two years, ClearPoint Neuro has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ClearPoint. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. ClearPoint Prism Neuro Laser Therapy System FDA Regulatory Events ClearPoint Prism Neuro Laser Therapy System is a drug developed by ClearPoint Neuro for the following indication: Brain Tumor Laser Therapy. 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. Results - October 7,2025Results Phase 1/2Drug: ClearPoint Prism Neuro Laser Therapy SystemAnnounced Date: October 7, 2025Indication: Brain Tumor Laser TherapyAnnouncementClearPoint Neuro, Inc announced results from a Phase I-II clinical study at Skåne University Hospital in Lund, Sweden evaluating the ClearPoint Prism Neuro Laser Therapy System's safety, feasibility, and efficacy..AI SummaryClearPoint Neuro, Inc. shared Phase I-II study results from Skåne University Hospital in Lund, Sweden. This trial tested the ClearPoint Prism Neuro Laser Therapy System for safety, feasibility, and effectiveness in 14 patients with primary or recurrent glioblastoma or grade 4 astrocytoma. The findings showed improved survival compared to matched open‐surgery controls, with no device‐related events or complications. The workflow proved safe, feasible, and reproducible, and the median time to ablate each tumor was just 6.5 minutes. Chris Osswald, PhD, said these results show potential for minimally invasive neuro‐oncology treatment. He added that the system’s fast, simple, and predictable workflow can improve patient care and support future cell and gene therapy applications. The ClearPoint Prism Neuro Laser Therapy System will be featured at the 75th Annual Congress of Neurological Surgeons in Los Angeles on October 13–15, 2025.Read Announcement ClearPoint Neuro FDA Events - Frequently Asked Questions Has ClearPoint Neuro received FDA approval? As of now, ClearPoint Neuro (CLPT) has not received any FDA approvals for its therapy in the last two years. What drugs has ClearPoint Neuro submitted to the FDA? In the past two years, ClearPoint Neuro (CLPT) has reported FDA regulatory activity for ClearPoint Prism Neuro Laser Therapy System. What is the most recent FDA event for ClearPoint Neuro? The most recent FDA-related event for ClearPoint Neuro occurred on October 7, 2025, involving ClearPoint Prism Neuro Laser Therapy System. The update was categorized as "Results," with the company reporting: "ClearPoint Neuro, Inc announced results from a Phase I-II clinical study at Skåne University Hospital in Lund, Sweden evaluating the ClearPoint Prism Neuro Laser Therapy System's safety, feasibility, and efficacy.." What conditions do ClearPoint Neuro's current drugs treat? Currently, ClearPoint Neuro has one therapy (ClearPoint Prism Neuro Laser Therapy System) targeting the following condition: Brain Tumor Laser Therapy. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Allogene Therapeutics FDA EventsEstrella Immunopharma FDA EventsEton Pharmaceuticals FDA EventsIncyte FDA EventsMannKind FDA EventsOcugen FDA EventsPulse Biosciences FDA EventsPolyPid FDA EventsSilexion Therapeutics FDA EventsTScan Therapeutics FDA EventsUnited Therapeutics FDA EventsViatris FDA EventsAbbVie FDA EventsAbeona Therapeutics FDA EventsAltimmune 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 Inspire Medical Systems FDA Events Alpha Tau Medical FDA Events Artivion FDA Events PROCEPT BioRobotics FDA Events Bioventus FDA Events SS Innovations International FDA Events Spyglass Pharma FDA Events Tactile Systems Technology FDA Events Brainsway FDA Events NeuroPace FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:CLPT last updated on 10/8/2025 by MarketBeat.com Staff. 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Results - October 7,2025Results Phase 1/2Drug: ClearPoint Prism Neuro Laser Therapy SystemAnnounced Date: October 7, 2025Indication: Brain Tumor Laser TherapyAnnouncementClearPoint Neuro, Inc announced results from a Phase I-II clinical study at Skåne University Hospital in Lund, Sweden evaluating the ClearPoint Prism Neuro Laser Therapy System's safety, feasibility, and efficacy..AI SummaryClearPoint Neuro, Inc. shared Phase I-II study results from Skåne University Hospital in Lund, Sweden. This trial tested the ClearPoint Prism Neuro Laser Therapy System for safety, feasibility, and effectiveness in 14 patients with primary or recurrent glioblastoma or grade 4 astrocytoma. The findings showed improved survival compared to matched open‐surgery controls, with no device‐related events or complications. The workflow proved safe, feasible, and reproducible, and the median time to ablate each tumor was just 6.5 minutes. Chris Osswald, PhD, said these results show potential for minimally invasive neuro‐oncology treatment. He added that the system’s fast, simple, and predictable workflow can improve patient care and support future cell and gene therapy applications. The ClearPoint Prism Neuro Laser Therapy System will be featured at the 75th Annual Congress of Neurological Surgeons in Los Angeles on October 13–15, 2025.Read Announcement
