Niagen Bioscience (NAGE) FDA Approvals $3.36 -0.11 (-3.03%) As of 10:39 AM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Niagen Bioscience's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Niagen Bioscience (NAGE). Over the past two years, Niagen Bioscience has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as NB4168. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. NB4168 FDA Regulatory Events NB4168 is a drug developed by Niagen Bioscience for the following indication: Treatment Of Ataxia Telangiectasia. 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. Designation Grant - July 13,2026Designation Grant RPD DesignationDrug: NB4168Announced Date: July 13, 2026Indication: Treatment Of Ataxia TelangiectasiaAnnouncementNNiagen Bioscience Receives FDA Rare Pediatric Disease Designation For Its Drug Candidate NB4168 For The Treatment Of Ataxia TelangiectasiaAI SummaryNNiagen Bioscience said its drug candidate NB4168 received Rare Pediatric Disease designation from the U.S. Food and Drug Administration for the treatment of ataxia telangiectasia, a rare and serious disease that mainly affects children. The company said the recognition supports its plan to develop a therapy for a condition with no approved treatments. It also sees the designation as an important sign of support for NB4168 and its broader work in rare disease medicines. Ataxia telangiectasia is a progressive disorder that can cause trouble with movement, immune problems, and other health issues. NNiagen Bioscience said the FDA designation may help speed development and give the program added visibility. The company said it believes NB4168 could become an important new option for patients and families facing this unmet medical need.Read Announcement Niagen Bioscience FDA Events - Frequently Asked Questions Has Niagen Bioscience received FDA approval? As of now, Niagen Bioscience (NAGE) has not received any FDA approvals for its therapy in the last two years. What drugs has Niagen Bioscience submitted to the FDA? In the past two years, Niagen Bioscience (NAGE) has reported FDA regulatory activity for NB4168. What is the most recent FDA event for Niagen Bioscience? The most recent FDA-related event for Niagen Bioscience occurred on July 13, 2026, involving NB4168. The update was categorized as "Designation Grant," with the company reporting: "NNiagen Bioscience Receives FDA Rare Pediatric Disease Designation For Its Drug Candidate NB4168 For The Treatment Of Ataxia Telangiectasia" What conditions do Niagen Bioscience's current drugs treat? Currently, Niagen Bioscience has one therapy (NB4168) targeting the following condition: Treatment Of Ataxia Telangiectasia. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Acurx Pharmaceuticals FDA EventsAtea Pharmaceuticals FDA EventsHemab Therapeutics FDA EventsIronwood Pharmaceuticals FDA EventsKura Oncology FDA EventsAvidity Biosciences FDA EventsSpero Therapeutics FDA EventsAgilent Technologies FDA EventsAligos Therapeutics FDA EventsANI Pharmaceuticals FDA EventsArtelo Biosciences FDA EventsBiogen FDA EventsBioMarin Pharmaceutical FDA EventsEnlivex Therapeutics FDA EventsErasca 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 Vor Biopharma FDA Events Sana Biotechnology FDA Events Solid Biosciences FDA Events Olema Pharmaceuticals FDA Events Kura Oncology FDA Events BioAge Labs FDA Events Avalo Therapeutics FDA Events Arbutus Biopharma FDA Events Janux Therapeutics FDA Events Pharming Group FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:NAGE last updated on 7/13/2026 by MarketBeat.com Staff. 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Designation Grant - July 13,2026Designation Grant RPD DesignationDrug: NB4168Announced Date: July 13, 2026Indication: Treatment Of Ataxia TelangiectasiaAnnouncementNNiagen Bioscience Receives FDA Rare Pediatric Disease Designation For Its Drug Candidate NB4168 For The Treatment Of Ataxia TelangiectasiaAI SummaryNNiagen Bioscience said its drug candidate NB4168 received Rare Pediatric Disease designation from the U.S. Food and Drug Administration for the treatment of ataxia telangiectasia, a rare and serious disease that mainly affects children. The company said the recognition supports its plan to develop a therapy for a condition with no approved treatments. It also sees the designation as an important sign of support for NB4168 and its broader work in rare disease medicines. Ataxia telangiectasia is a progressive disorder that can cause trouble with movement, immune problems, and other health issues. NNiagen Bioscience said the FDA designation may help speed development and give the program added visibility. The company said it believes NB4168 could become an important new option for patients and families facing this unmet medical need.Read Announcement
