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.
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Gilead Sciences (Nasdaq: GILD) agreed to acquire Arcellx (Nasdaq: ACLX) for $115 per share cash plus a $5 CVR, implying an equity value of $7.8 billion. The deal carries a 68% premium to Arcellx’s 30‑day VWAP and is expected to close in Q2 2026, subject to tender and regulatory approvals.
The acquisition gives Gilead full control of anito-cel, whose BLA was accepted by FDA with a PDUFA date of Dec 23, 2026, and is expected to be accretive to EPS in 2028 if approved.
Arcellx (NASDAQ: ACLX) will present late-breaking preclinical data on February 5, 2026 at the Tandem Meetings showing its D-Domain binder in anitocabtagene autoleucel (anito-cel) lacked tonic signaling and Claudin-9 cross-reactivity in head-to-head CAR constructs versus dual VHH and scFv binders.
Results showed dual VHH (cilta-cel-like) exhibited tonic signaling and CLDN9 off-target activity, while the D-Domain and scFv did not, supporting a differentiated target-specificity and favorable safety profile for anito-cel.
Arcellx (NASDAQ: ACLX) will present three research abstracts at the 2026 Tandem Meetings (Feb 4-7, 2026) in Salt Lake City on its D-Domain platform and anito-cel for multiple myeloma. One presentation describes the D-Domain binder's fast off-rate and a mechanistic rationale for anito-cel’s differentiated pharmacology. A simulation model reports using CAR T before bispecific antibodies in 4L+ RRMM could lower risk of progression or death by 64% and death by 48% over five years versus the reverse sequence. A separate study highlights geographic inequities in CAR T access, noting long travel and out-of-state care that suggest referral gaps and ATC expansion needs. Anito-cel is partnered with Kite, a Gilead Company.
Arcellx (NASDAQ: ACLX) reported updated pivotal Phase 2 iMMagine-1 results for anitocabtagene autoleucel (anito-cel) in 117 relapsed/refractory multiple myeloma patients with a median follow-up of 15.9 months (data cutoff Oct 7, 2025).
Key efficacy: ORR 96%, CR/sCR 74%, ≥VGPR 88%; MRD negativity 95% (91/96) and sustained MRD negativity >6 months 83% (54/65) at 10-5 sensitivity. Timepoint survival: 12‑month PFS/OS 82.1%/94.0%, 18‑month PFS/OS 67.4%/88.0%, 24‑month PFS/OS 61.7%/83.0%.
Safety: no delayed or non‑ICANS neurotoxicities observed to date (all patients dosed ≥12 months). Company reiterates planned 2026 commercial launch. Data presented at ASH on December 6, 2025.
Arcellx (NASDAQ: ACLX) will host an Investor Relations event on Saturday, December 6, 2025 at 8:00 p.m. ET in Redwood City.
The session will feature a panel of clinician experts and a discussion of the latest data from the company’s Phase 2 pivotal iMMagine-1 study in patients with relapsed or refractory multiple myeloma. A live webcast will be accessible from Arcellx's Investors website and a replay will be archived and available for 30 days after the event.
Arcellx (NASDAQ: ACLX) reported third quarter 2025 results for the period ended September 30, 2025. Key financials: $576.0 million in cash, cash equivalents, and marketable securities; company expects these funds to support operations into 2028. Collaboration revenue fell to $4.9 million from $26.0 million, largely due to completion of dosing and manufacturing of anito-cel in iMMagine-1 in Q4 2024. R&D expense decreased to $35.1 million while G&A rose to $31.6 million. Net loss widened to $55.8 million from $25.9 million year-over-year.
Arcellx (NASDAQ: ACLX) will present updated clinical and preclinical data at the 67th ASH Annual Meeting (Dec 6-9, 2025) in Orlando. An oral presentation on iMMagine-1 (Phase 2 registrational study of anitocabtagene autoleucel) is scheduled for Dec 6, 2025 at 2:45 p.m. ET (publication #256).
The company said a more recent data cut will be shared, no delayed neurotoxicities (including Parkinsonism, cranial nerve palsies, Guillain-Barré, or immune effector cell-associated enterocolitis) have been observed to date, and a supplemental Blood publication on anito-cel’s D-Domain fast off-rate will appear in November 2025 (publication #7644). Arcellx reported a pre-BLA meeting with the FDA and reiterated a planned 2026 commercial launch.