City Therapeutics (CTY) FDA Approvals $19.62 +0.95 (+5.09%) As of 11/10/2026 04:00 PM Eastern Add Share Share FDA Events Stock AnalysisAnalyst ForecastsChartFDA EventsInsider TradesNews and TrendsSEC Filings City Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by City Therapeutics (CTY). Over the past two years, City Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CITY-RBP4. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. CITY-RBP4 FDA Regulatory Events CITY-RBP4 is a drug developed by City Therapeutics for the following indication: Treatment of Stargardt Disease. 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. Dose Update - November 10,2026Dose Update Phase 1Drug: CITY-RBP4Announced Date: November 10, 2026Indication: Treatment of Stargardt DiseaseAnnouncementCity Therapeutics, Inc. announced that the first participant has been dosed in the Phase 1 clinical trial of CITY-RBP4, an investigational RNAi therapeutic candidate for the treatment of Stargardt disease type 1 (Stargardt disease).Read Announcement City Therapeutics FDA Events - Frequently Asked Questions Has City Therapeutics received FDA approval? As of now, City Therapeutics (CTY) has not received any FDA approvals for its therapy in the last two years. What drugs has City Therapeutics submitted to the FDA? In the past two years, City Therapeutics (CTY) has reported FDA regulatory activity for CITY-RBP4. What is the most recent FDA event for City Therapeutics? The most recent FDA-related event for City Therapeutics occurred on November 10, 2026, involving CITY-RBP4. The update was categorized as "Dose Update," with the company reporting: "City Therapeutics, Inc. announced that the first participant has been dosed in the Phase 1 clinical trial of CITY-RBP4, an investigational RNAi therapeutic candidate for the treatment of Stargardt disease type 1 (Stargardt disease)." What conditions do City Therapeutics' current drugs treat? Currently, City Therapeutics has one therapy (CITY-RBP4) targeting the following condition: Treatment of Stargardt Disease. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Prima BioMed FDA EventsBlack Diamond Therapeutics FDA EventsBeam Therapeutics FDA EventsBioVie FDA EventsBiomea Fusion FDA EventsCingulate FDA EventsCity Therapeutics FDA EventsFate Therapeutics FDA EventsKailera Therapeutics FDA EventsLipocine FDA EventsLantern Pharma FDA EventsMetagenomi FDA EventsMirum Pharmaceuticals FDA EventsPalisade Bio FDA EventsJohnson & Johnson 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 Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:CTY last updated on 11/10/2026 by MarketBeat.com Staff. 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Dose Update - November 10,2026Dose Update Phase 1Drug: CITY-RBP4Announced Date: November 10, 2026Indication: Treatment of Stargardt DiseaseAnnouncementCity Therapeutics, Inc. announced that the first participant has been dosed in the Phase 1 clinical trial of CITY-RBP4, an investigational RNAi therapeutic candidate for the treatment of Stargardt disease type 1 (Stargardt disease).Read Announcement
