Celularity (CELU) FDA Approvals $1.02 -0.04 (-3.77%) Closing price 04:00 PM EasternExtended Trading$1.02 0.00 (-0.39%) As of 04:13 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 EventsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Celularity's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Celularity (CELU). Over the past two years, Celularity has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as PDA-002. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. PDA-002 FDA Regulatory Events PDA-002 is a drug developed by Celularity for the following indication: For treating Facioscapulohumeral Muscular Dystrophy (FSHD). 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. Publication - October 14,2025Publication Phase 2Drug: PDA-002Announced Date: October 14, 2025Indication: For treating Facioscapulohumeral Muscular Dystrophy (FSHD).AnnouncementCelularity Inc. announced the publication of its Phase 2 study titled "Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial," in the International Wound Journal.AI SummaryCelularity Inc. announced the publication of its Phase 2 study of PDA-002 in diabetic foot ulcer patients with and without peripheral artery disease (PAD) in the International Wound Journal. This trial tested the safety and effectiveness of PDA-002, a placenta-derived cell therapy, in complex wounds among diabetic patients. The study enrolled 159 adults across 35 U.S. sites. Participants received two intramuscular doses of PDA-002 at three dose levels or placebo. The main goal was complete wound closure within three months with healing lasting at least four more weeks. In PAD patients, the lowest dose (3 × 10^6 cells) achieved a 38.5% closure rate versus 22.6% with placebo. Treated patients healed faster, had fewer cases of gangrene and infections, and had no serious side effects over two years. These findings support further trials to confirm PDA-002 as a novel regenerative therapy for hard-to-treat diabetic ulcers.Read Announcement Celularity FDA Events - Frequently Asked Questions Has Celularity received FDA approval? As of now, Celularity (CELU) has not received any FDA approvals for its therapy in the last two years. What drugs has Celularity submitted to the FDA? In the past two years, Celularity (CELU) has reported FDA regulatory activity for PDA-002. What is the most recent FDA event for Celularity? The most recent FDA-related event for Celularity occurred on October 14, 2025, involving PDA-002. The update was categorized as "Publication," with the company reporting: "Celularity Inc. announced the publication of its Phase 2 study titled "Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial," in the International Wound Journal." What conditions do Celularity's current drugs treat? Currently, Celularity has one therapy (PDA-002) targeting the following condition: For treating Facioscapulohumeral Muscular Dystrophy (FSHD).. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events argenex FDA EventsAxsome Therapeutics FDA EventsBiogen FDA EventsCabaletta Bio FDA EventsDyne Therapeutics FDA EventsFibroBiologics FDA EventsIDEAYA Biosciences FDA EventsLexicon Pharmaceuticals FDA EventsMannKind FDA EventsInsulet FDA EventsTG Therapeutics FDA EventsTenaya Therapeutics FDA EventsJohnson & Johnson FDA EventsCandel Therapeutics FDA EventsCelcuity 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 Verrica Pharmaceuticals FDA Events Pyxis Oncology FDA Events Biomea Fusion FDA Events Oncolytics Biotech FDA Events Aardvark Therapeutics FDA Events Anixa Biosciences FDA Events Rein Therapeutics FDA Events Athira Pharma FDA Events Atara Biotherapeutics FDA Events Edesa Biotech FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:CELU last updated on 10/14/2025 by MarketBeat.com Staff. 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Publication - October 14,2025Publication Phase 2Drug: PDA-002Announced Date: October 14, 2025Indication: For treating Facioscapulohumeral Muscular Dystrophy (FSHD).AnnouncementCelularity Inc. announced the publication of its Phase 2 study titled "Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial," in the International Wound Journal.AI SummaryCelularity Inc. announced the publication of its Phase 2 study of PDA-002 in diabetic foot ulcer patients with and without peripheral artery disease (PAD) in the International Wound Journal. This trial tested the safety and effectiveness of PDA-002, a placenta-derived cell therapy, in complex wounds among diabetic patients. The study enrolled 159 adults across 35 U.S. sites. Participants received two intramuscular doses of PDA-002 at three dose levels or placebo. The main goal was complete wound closure within three months with healing lasting at least four more weeks. In PAD patients, the lowest dose (3 × 10^6 cells) achieved a 38.5% closure rate versus 22.6% with placebo. Treated patients healed faster, had fewer cases of gangrene and infections, and had no serious side effects over two years. These findings support further trials to confirm PDA-002 as a novel regenerative therapy for hard-to-treat diabetic ulcers.Read Announcement
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