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, Inc. (NASDAQ: ACLX) announced the appointment of Olivia Ware to its Board of Directors, replacing Lewis T. "Rusty" Williams, M.D. Ware brings over 20 years of experience in biotech and pharmaceutical drug development, having played key roles in launching major oncology drugs such as Rituxan and Herceptin. Her expertise is expected to enhance the company's strategic direction, especially as it prepares for a Phase 2 study of CART-ddBCMA for relapsed or refractory multiple myeloma. The company is focused on advancing innovative immunotherapies and has received multiple FDA designations for its lead product.
Arcellx, Inc. (NASDAQ: ACLX) initiated a Phase 1 clinical trial for ACLX-001 utilizing its innovative ARC-SparX technology to treat relapsed or refractory multiple myeloma (r/r MM). The company raised $142 million in its IPO and reported cash reserves of $210.9 million as of March 31, 2022, sufficient to fund operations into late 2023. Unfortunately, they posted a net loss of $32.4 million with R&D expenses increasing to $24.4 million. Upcoming presentations at the ASCO Annual Meeting are anticipated to provide further insights into their clinical data.
Arcellx, Inc. (NASDAQ: ACLX) has initiated its Phase 1 clinical trial for ACLX-001, targeting relapsed or refractory multiple myeloma (r/r MM). The trial, utilizing the innovative ARC-SparX platform, aims to evaluate safety and tolerability while addressing challenges like dose-limiting toxicities and tumor heterogeneity. The first patient has been dosed, and initial data is expected in 2023. The ARC-SparX technology combines SparX proteins and ARC-T cells to enable controlled and adaptable treatment options, potentially enhancing patient access to CAR-T therapies.
On May 9, 2022, Arcellx, Inc. (ACLX) announced key clinical data for CART-ddBCMA from its ongoing Phase 1 study aimed at treating relapsed or refractory multiple myeloma. Published in Blood Advances, the findings show a 100% overall response rate (ORR) and a 75% complete response/sustained complete response (CR/sCR) in 12 patients. The trial reported no significant adverse effects, solidifying CART-ddBCMA's safety profile. Following these results, Arcellx plans to expand the study and present new data at ASCO on June 5, with a pivotal Phase 2 study expected later in 2022.
Arcellx, Inc. (NASDAQ: ACLX) will participate in a fireside chat at the BofA Securities 2022 Healthcare Conference on May 11, 2022, at 5:00 p.m. E.T. The discussion will be accessible via a live webcast on the company's website and will be archived for 30 days. Arcellx focuses on developing advanced immunotherapies for cancer and other diseases, with its lead candidate CART-ddBCMA currently in a Phase 1 study for relapsed or refractory multiple myeloma. The company holds multiple designations from the FDA to expedite its clinical development.
Arcellx, Inc. (NASDAQ: ACLX) announced the upcoming presentation of new clinical data from its Phase 1 Study of CART-ddBCMA for treating relapsed or refractory multiple myeloma at the ASCO Annual Meeting on June 5, 2022. The oral presentation will be delivered by Dr. Matthew J. Frigault from Massachusetts General Cancer Center. The company will also host a live webcast discussing these results on the same day. CART-ddBCMA has received Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations from the FDA, underscoring its potential in cell therapy.
Arcellx (ACLX) announced promising preclinical data for ACLX-002, a CD123-targeted universal CAR-T cell therapy aimed at treating relapsed or refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The data show complete regression of multiple AML xenografts, evidencing the therapy's potential effectiveness. The company plans to initiate a Phase 1 clinical trial for ACLX-002 in the second half of 2022. The findings were presented at the AACR Annual Meeting, highlighting the innovative ARC-SparX platform that aims to improve treatment options for patients.
Arcellx, Inc. (NASDAQ: ACLX) raised $142.3 million via its upsized IPO, completed in February 2022, enhancing its ability to advance innovative therapies for cancer. The company reported a net loss of $65 million for 2021, up from $32 million in 2020. R&D expenses rose significantly to $46.9 million for the year, driven by developments in its CART-ddBCMA program. Arcellx plans to progress its CART-ddBCMA program to Phase 2 and initiate two Phase 1 trials in 2022.
Arcellx, Inc. (NASDAQ: ACLX) announced participation by CEO Rami Elghandour and CMO Chris Heery in a fireside chat at the Barclays Global Healthcare Conference on March 16, 2022, at 4:50 p.m. E.T. The discussion will be accessible via a live webcast on Arcellx's website, with a replay available for 30 days post-event. The company is focused on advancing cell therapies, particularly CART-ddBCMA for relapsed or refractory multiple myeloma, and is progressing ARC-SparX for acute myeloid leukemia. Both product candidates have received various FDA designations.
Arcellx, Inc. (NASDAQ: ACLX) announced the presentation of pre-clinical data for ACLX-002, a CD123-targeted CAR-T cell therapy aimed at treating relapsed or refractory Acute Myeloid Leukemia (AML), at the American Association for Cancer Research Annual Meeting 2022. ACLX-002 offers controllability through a dose-dependent activation mechanism, addressing patient-specific disease variations and reducing the risk of adverse events. The presentation is scheduled for April 10, 2022, at the New Orleans Convention Center, highlighting the company's commitment to advancing innovative cancer therapies.