ProPhase Labs (PRPH) FDA Approvals $0.09 0.00 (-2.02%) As of 10:25 AM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesOptions ChainOwnershipSEC FilingsTrendsBuy This Stock ProPhase Labs' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by ProPhase Labs (PRPH). Over the past two years, ProPhase Labs has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BE-Smart. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. BE-Smart FDA Regulatory Events BE-Smart is a drug developed by ProPhase Labs for the following indication: esophageal cancer test. 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. Clinical Study - October 22,2025Clinical Study Drug: BE-SmartAnnounced Date: October 22, 2025Indication: esophageal cancer testAnnouncementProPhase Labs Inc. announced today that its pivotal clinical study by Hartley et al. (2025) validating the BE-Smart™ esophageal cancer test has been accepted for publication in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association.AI SummaryProPhase Labs announced that its pivotal clinical study by Hartley et al. (2025), validating the BE-Smart™ esophageal cancer test, has been accepted for publication in Clinical Gastroenterology and Hepatology. The study shows BE-Smart achieved 100% sensitivity in detecting patients who later developed cancer and demonstrated strong predictive accuracy with an AUC up to 1.0. BE-Smart is an eight-protein, mass-spectrometry assay that stratifies the risk of progression from Barrett’s Esophagus to high-grade dysplasia or esophageal adenocarcinoma. With millions of endoscopies performed annually for GERD and Barrett’s surveillance, the test targets a multibillion-dollar market. ProPhase is advancing regulatory filings, scaling its laboratory operations and partnering with leading gastroenterology practices. A phased commercial rollout is planned for 2026, allowing physicians to order BE-Smart through standard pathology channels. This milestone sets the stage for revenue growth and wider access to advanced molecular screening.Read Announcement ProPhase Labs FDA Events - Frequently Asked Questions Has ProPhase Labs received FDA approval? As of now, ProPhase Labs (PRPH) has not received any FDA approvals for its therapy in the last two years. What drugs has ProPhase Labs submitted to the FDA? In the past two years, ProPhase Labs (PRPH) has reported FDA regulatory activity for BE-Smart. What is the most recent FDA event for ProPhase Labs? The most recent FDA-related event for ProPhase Labs occurred on October 22, 2025, involving BE-Smart. The update was categorized as "Clinical Study," with the company reporting: "ProPhase Labs Inc. announced today that its pivotal clinical study by Hartley et al. (2025) validating the BE-Smart™ esophageal cancer test has been accepted for publication in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association." What conditions do ProPhase Labs' current drugs treat? Currently, ProPhase Labs has one therapy (BE-Smart) targeting the following condition: esophageal cancer test. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events AC Immune FDA EventsAptevo Therapeutics FDA EventsHeartBeam FDA EventsCandel Therapeutics FDA EventsCogent Biosciences FDA EventsDesign Therapeutics FDA EventsNovoCure FDA EventsSCYNEXIS FDA EventsStoke Therapeutics FDA EventsVistaGen Therapeutics FDA EventsADC Therapeutics FDA EventsArcutis Biotherapeutics FDA EventsArtelo Biosciences FDA EventsBiogen FDA EventsBrainsway 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 CASI Pharmaceuticals FDA Events Purple Biotech FDA Events Iterum Therapeutics FDA Events Jaguar Animal Health FDA Events PMGC FDA Events Abpro FDA Events PainReform FDA Events Trinity Biotech FDA Events Silexion Therapeutics FDA Events Scinai Immunotherapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:PRPH last updated on 10/22/2025 by MarketBeat.com Staff. 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Clinical Study - October 22,2025Clinical Study Drug: BE-SmartAnnounced Date: October 22, 2025Indication: esophageal cancer testAnnouncementProPhase Labs Inc. announced today that its pivotal clinical study by Hartley et al. (2025) validating the BE-Smart™ esophageal cancer test has been accepted for publication in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association.AI SummaryProPhase Labs announced that its pivotal clinical study by Hartley et al. (2025), validating the BE-Smart™ esophageal cancer test, has been accepted for publication in Clinical Gastroenterology and Hepatology. The study shows BE-Smart achieved 100% sensitivity in detecting patients who later developed cancer and demonstrated strong predictive accuracy with an AUC up to 1.0. BE-Smart is an eight-protein, mass-spectrometry assay that stratifies the risk of progression from Barrett’s Esophagus to high-grade dysplasia or esophageal adenocarcinoma. With millions of endoscopies performed annually for GERD and Barrett’s surveillance, the test targets a multibillion-dollar market. ProPhase is advancing regulatory filings, scaling its laboratory operations and partnering with leading gastroenterology practices. A phased commercial rollout is planned for 2026, allowing physicians to order BE-Smart through standard pathology channels. This milestone sets the stage for revenue growth and wider access to advanced molecular screening.Read Announcement
