This company has been marked as potentially delisted and may not be actively trading. Arcellx (ACLX) FDA Approvals Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsEarningsFDA EventsHeadlinesInsider TradesOwnershipShort InterestTrendsBuy This Stock Arcellx's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Arcellx (ACLX). Over the past two years, Arcellx has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as anitocabtagene. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Anitocabtagene autoleucel FDA Regulatory Timeline and Events Anitocabtagene autoleucel is a drug developed by Arcellx for the following indication: In patients with relapsed or refractory multiple myeloma. 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. Late-breaking abstract - February 4,2026Late-Breaking Abstract Drug: anitocabtagene autoleucelAnnounced Date: February 4, 2026Indication: In patients with relapsed or refractory multiple myelomaAnnouncementArcellx, Inc. announced that a late-breaking abstract for its novel D-Domain binder in anitocabtagene autoleucel (anito-cel) has been accepted for presentation at the 2026 Tandem Meetings.AI SummaryArcellx, Inc. announced that a late-breaking abstract on its novel D-Domain binder in anitocabtagene autoleucel (anito-cel) was accepted for presentation at the 2026 Tandem Meetings. The presentation is scheduled for February 5 in Salt Lake City, UT, and the study aims to examine how different binder types affect the specificity of BCMA-directed CAR‑T cells. In preclinical tests comparing D-Domain (anito-cel) with a dual VHH binder and an scFv, the D-Domain showed no tonic signaling or off-target Claudin binding, while the dual VHH displayed specific off-target activity against Claudin‑9. The dual VHH and scFv also triggered CAR‑T activation and cytokine release without BCMA antigen, but the D-Domain did not. These results suggest the D-Domain may provide strong anti-tumor activity while minimizing tonic signaling and off‑target reactivity, supporting a potentially improved safety profile for anito-cel.Read AnnouncementPositive Data - May 14,2025Positive Data Drug: anitocabtagene autoleucelAnnounced Date: May 14, 2025Indication: In patients with relapsed or refractory multiple myelomaAnnouncementArcellx, Inc announced new positive data from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel), in patients with relapsed or refractory multiple myeloma (RRMM).AI SummaryArcellx, Inc. announced positive new results from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel) in patients with relapsed or refractory multiple myeloma. In the study, all 117 patients treated showed promising outcomes with a 97% overall response rate and a 68% complete or stringent complete response rate at a median follow-up of 12.6 months. This indicates a strong effect of anito-cel in heavily pre-treated patients, including those with triple- and penta-refractory disease. Importantly, the study demonstrated a favorable safety profile. No delayed neurotoxicities—such as Parkinsonism, cranial nerve palsies, or Guillain-Barré syndrome—and no immune-mediated enterocolitis were reported. These encouraging results support anito-cel’s potential as an effective and safe treatment option for multiple myeloma patients, with detailed data to be presented at the EHA2025 Congress in Milan.Read AnnouncementPositive Data - December 8,2024Positive Data Phase 2Drug: anitocabtagene autoleucelAnnounced Date: December 8, 2024Indication: In patients with relapsed or refractory multiple myelomaAnnouncementArcellx, Inc announced new positive data from its Phase 2 pivotal iMMagine-1 study of anitocabtagene autoleucel (anito-cel), in patients with relapsed or refractory multiple myeloma (RRMM).AI SummaryArcellx, Inc. announced positive results from its Phase 2 pivotal iMMagine-1 study of anitocabtagene autoleucel (anito-cel) in relapsed or refractory multiple myeloma (RRMM) patients. Among 86 efficacy evaluable patients, the study reported a 97% overall response rate, including a 62% complete/stringent complete response rate at a median follow-up of 9.5 months. These promising outcomes suggest that anito-cel may provide deep and durable responses for patients who have received multiple prior treatments. Furthermore, the safety profile remains manageable, as no delayed neurotoxicities—such as Parkinsonism, cranial nerve palsies, or Guillain-Barré syndrome—have been observed in over 150 patients treated to date. The new data will be highlighted at the upcoming American Society of Hematology Annual Meeting, showcasing anito-cel’s potential as a best-in-class CAR T-cell therapy for RRMM.Read Announcement Arcellx FDA Events - Frequently Asked Questions Has Arcellx received FDA approval? As of now, Arcellx (ACLX) has not received any FDA approvals for its therapy in the last two years. What drugs has Arcellx submitted to the FDA? In the past two years, Arcellx (ACLX) has reported FDA regulatory activity for anitocabtagene autoleucel. What is the most recent FDA event for Arcellx? The most recent FDA-related event for Arcellx occurred on February 4, 2026, involving anitocabtagene autoleucel. The update was categorized as "Late-breaking abstract," with the company reporting: "Arcellx, Inc. announced that a late-breaking abstract for its novel D-Domain binder in anitocabtagene autoleucel (anito-cel) has been accepted for presentation at the 2026 Tandem Meetings." What conditions do Arcellx's current drugs treat? Currently, Arcellx has one therapy (anitocabtagene autoleucel) targeting the following condition: In patients with relapsed or refractory multiple myeloma. 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 BioNTech FDA Events Insmed FDA Events Roivant Sciences FDA Events Viatris FDA Events Moderna FDA Events Genmab A/S FDA Events Ascendis Pharma A/S FDA Events BridgeBio Pharma FDA Events Summit Therapeutics FDA Events Axsome Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:ACLX last updated on 2/4/2026 by MarketBeat.com Staff. 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Late-breaking abstract - February 4,2026Late-Breaking Abstract Drug: anitocabtagene autoleucelAnnounced Date: February 4, 2026Indication: In patients with relapsed or refractory multiple myelomaAnnouncementArcellx, Inc. announced that a late-breaking abstract for its novel D-Domain binder in anitocabtagene autoleucel (anito-cel) has been accepted for presentation at the 2026 Tandem Meetings.AI SummaryArcellx, Inc. announced that a late-breaking abstract on its novel D-Domain binder in anitocabtagene autoleucel (anito-cel) was accepted for presentation at the 2026 Tandem Meetings. The presentation is scheduled for February 5 in Salt Lake City, UT, and the study aims to examine how different binder types affect the specificity of BCMA-directed CAR‑T cells. In preclinical tests comparing D-Domain (anito-cel) with a dual VHH binder and an scFv, the D-Domain showed no tonic signaling or off-target Claudin binding, while the dual VHH displayed specific off-target activity against Claudin‑9. The dual VHH and scFv also triggered CAR‑T activation and cytokine release without BCMA antigen, but the D-Domain did not. These results suggest the D-Domain may provide strong anti-tumor activity while minimizing tonic signaling and off‑target reactivity, supporting a potentially improved safety profile for anito-cel.Read Announcement
Positive Data - May 14,2025Positive Data Drug: anitocabtagene autoleucelAnnounced Date: May 14, 2025Indication: In patients with relapsed or refractory multiple myelomaAnnouncementArcellx, Inc announced new positive data from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel), in patients with relapsed or refractory multiple myeloma (RRMM).AI SummaryArcellx, Inc. announced positive new results from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel) in patients with relapsed or refractory multiple myeloma. In the study, all 117 patients treated showed promising outcomes with a 97% overall response rate and a 68% complete or stringent complete response rate at a median follow-up of 12.6 months. This indicates a strong effect of anito-cel in heavily pre-treated patients, including those with triple- and penta-refractory disease. Importantly, the study demonstrated a favorable safety profile. No delayed neurotoxicities—such as Parkinsonism, cranial nerve palsies, or Guillain-Barré syndrome—and no immune-mediated enterocolitis were reported. These encouraging results support anito-cel’s potential as an effective and safe treatment option for multiple myeloma patients, with detailed data to be presented at the EHA2025 Congress in Milan.Read Announcement
Positive Data - December 8,2024Positive Data Phase 2Drug: anitocabtagene autoleucelAnnounced Date: December 8, 2024Indication: In patients with relapsed or refractory multiple myelomaAnnouncementArcellx, Inc announced new positive data from its Phase 2 pivotal iMMagine-1 study of anitocabtagene autoleucel (anito-cel), in patients with relapsed or refractory multiple myeloma (RRMM).AI SummaryArcellx, Inc. announced positive results from its Phase 2 pivotal iMMagine-1 study of anitocabtagene autoleucel (anito-cel) in relapsed or refractory multiple myeloma (RRMM) patients. Among 86 efficacy evaluable patients, the study reported a 97% overall response rate, including a 62% complete/stringent complete response rate at a median follow-up of 9.5 months. These promising outcomes suggest that anito-cel may provide deep and durable responses for patients who have received multiple prior treatments. Furthermore, the safety profile remains manageable, as no delayed neurotoxicities—such as Parkinsonism, cranial nerve palsies, or Guillain-Barré syndrome—have been observed in over 150 patients treated to date. The new data will be highlighted at the upcoming American Society of Hematology Annual Meeting, showcasing anito-cel’s potential as a best-in-class CAR T-cell therapy for RRMM.Read Announcement
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