Welcome to our dedicated page for ARCELLX news (Ticker: ACLX), a resource for investors and traders seeking the latest updates and insights on ARCELLX stock.
Arcellx, Inc. (NASDAQ: ACLX) is a clinical-stage biotechnology company focused on cell therapy and immunotherapies for cancer and other incurable diseases. Its news flow is heavily driven by clinical data updates, regulatory interactions, and collaboration milestones related to its lead BCMA-directed CAR T-cell therapy, anitocabtagene autoleucel (anito-cel), for relapsed or refractory multiple myeloma.
Investors and observers following Arcellx news can expect regular announcements on the company’s pivotal Phase 2 iMMagine-1 study and its global Phase 3 iMMagine-3 trial. Recent releases have highlighted high overall response rates, deep responses, and high minimal residual disease (MRD) negativity in heavily pretreated multiple myeloma patients, along with detailed safety observations such as the absence of specific delayed neurotoxicities in reported data cuts.
Arcellx also issues news on key regulatory milestones, including a pre-BLA meeting with the U.S. Food and Drug Administration for anito-cel and the addition of MRD negativity as a dual primary endpoint in iMMagine-3. Updates on FDA designations for anito-cel, such as Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy status, are part of this regulatory-focused news stream.
Beyond multiple myeloma, Arcellx news covers pipeline expansion, such as FDA clearance of an IND for ACLX-004 targeting CD33 and CD123 using the ARC-SparX platform, as well as financial results, cash runway commentary, and collaboration developments with Kite, a Gilead Company. Coverage also includes participation in major scientific meetings like EHA and ASH, where Arcellx presents clinical data and scientific findings. For readers tracking ACLX, this news page provides a centralized view of clinical, regulatory, financial, and corporate developments that shape the company’s progress in cell therapy.
Arcellx (NASDAQ: ACLX) has appointed Andrew Galligan and Kristin Myers to its Board of Directors, while Derek Yoon steps down. The appointments come as the company prepares for potential commercialization in 2026.
Galligan, former CFO of Nevro Corp, brings over 30 years of strategic leadership experience, having driven commercial growth at multiple public companies. Myers, currently COO at Blue Cross Blue Shield Association, contributes 20+ years of healthcare expertise across payer, provider, and medtech sectors.
The appointments align with Arcellx's preparation for the anticipated commercial launch of anito-cel, their lead product candidate for relapsed or refractory multiple myeloma, through their partnership with Kite, a Gilead Company.
Arcellx (NASDAQ: ACLX) reported its Q4 and full-year 2024 financial results, highlighting significant progress in its anito-cel treatment for relapsed/refractory multiple myeloma (RRMM). The Phase 2 pivotal iMMagine-1 study showed impressive results with a 97% overall response rate and 62% complete response rate in 86 patients at 9.5 months median follow-up.
Key financial metrics include $625.7 million in cash and equivalents, providing runway into 2027. Q4 collaboration revenue was $15.3 million, down from $63.1 million in Q4 2023. Full-year net loss increased to $107.3 million from $70.7 million in 2023.
The company plans to commercially launch anito-cel in 2026 and will present updated iMMagine-1 data mid-2025. Notably, no delayed neurotoxicities were observed in 155 patients across Phase 1 and iMMagine-1 studies.
Arcellx (NASDAQ: ACLX), a biotechnology company focused on developing innovative immunotherapies for cancer and other incurable diseases, has announced its upcoming participation in the TD Cowen 45th Annual Health Care Conference. The company's management will engage in a fireside chat scheduled for Wednesday, March 5, at 1:10 p.m. ET.
Investors and interested parties can access a live webcast of the discussion through the Investors section of Arcellx's website at www.arcellx.com. The webcast recording will remain available for replay on the company's website for 30 days after the event.
Arcellx (NASDAQ: ACLX) 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. The study showed a 97% overall response rate and 62% complete response rate at a median follow-up of 9.5 months.
Key highlights include 93.1% minimal residual disease negativity among evaluable patients, and no delayed neurotoxicities observed in over 150 patients across Phase 1 and iMMagine-1 studies. The Phase 1 study demonstrated a 30.2-month median progression-free survival with median overall survival not reached. The safety profile showed 86% of patients had Grade ≤1 cytokine release syndrome, with 17% experiencing no CRS.
Arcellx reported Q3 2024 financial results and clinical progress for anito-cel in treating relapsed/refractory multiple myeloma. Phase 1 study showed 30.2-month median progression-free survival with 38.1 months median follow-up. Phase 2 iMMagine-1 study demonstrated 95% overall response rate and 62% complete response rate in 58 patients at 10.3 months median follow-up. No delayed neurotoxicities were observed in over 140 treated patients. The company reported $676.7 million in cash and equivalents, expected to fund operations into 2027. Q3 collaboration revenue increased to $26.0 million, while net loss decreased to $25.9 million.
Arcellx (NASDAQ: ACLX) announced clinical data from its Phase 1 and iMMagine-1 studies for anitocabtagene autoleucel (anito-cel) in relapsed/refractory multiple myeloma patients. The Phase 1 study showed a 30.2-month median progression-free survival with 38.1 months median follow-up. The Phase 2 iMMagine-1 study demonstrated 95% overall response rate and 62% complete response rate in 58 patients at 10.3 months median follow-up. No delayed neurotoxicities were observed in over 140 patients across both studies. The company also reported the first patient dosing in the iMMagine-3 study, manufactured by Kite.
Arcellx (NASDAQ: ACLX) reported its Q2 2024 financial results and business updates. Key highlights include:
- Earned a $68M milestone payment from Kite for iMMagine-1 enrollment
- Submitted an abstract for iMMagine-1 study at the 66th ASH Annual Meeting
- Kite initiated the global Phase 3 trial, iMMagine-3
- FDA cleared anito-cel IND application for myasthenia gravis
Financial highlights:
- Cash position: $646.8M, funding operations into 2027
- Collaboration revenue: $27.4M, up from $14.3M in Q2 2023
- R&D expenses: $41.0M, up from $28.3M in Q2 2023
- G&A expenses: $21.4M, up from $15.5M in Q2 2023
- Net loss: $27.2M, compared to $23.9M in Q2 2023
Arcellx and Kite, in partnership with Gilead Company, announced updates on their anitocabtagene autoleucel (anito-cel) multiple myeloma program. The global Phase 3 trial, iMMagine-3, will evaluate anito-cel in patients with relapsed and/or refractory multiple myeloma exposed to specific previous treatments. The technical transfer for manufacturing anito-cel is complete, and preliminary data from the iMMagine-1 trial is expected by year-end.
Kite, a Gilead Company, and Arcellx, Inc. announced operational updates on their anito-cel multiple myeloma program. They shared the iMMagine-3 trial design, manufacturing details, and plans to present data from the iMMagine-1 trial. Anito-cel is a BCMA CAR T cell therapy for relapsed/refractory multiple myeloma.