Earnings summaries and quarterly performance for Arcellx.
Executive leadership at Arcellx.
Board of directors at Arcellx.
Research analysts covering Arcellx.
Recent press releases and 8-K filings for ACLX.
Arcellx announces positive iMMagine-1 study data for anito-cel in multiple myeloma
ACLX
Product Launch
New Projects/Investments
- Arcellx, Inc. announced new positive data from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel) for patients with relapsed or refractory multiple myeloma (RRMM).
- The study, with a median follow-up of 15.9 months, demonstrated a 96% overall response rate (ORR) and a 74% complete response/stringent complete response (CR/sCR) rate.
- Key survival rates include 12-month progression-free survival (PFS) and overall survival (OS) rates of 82.1% and 94.0%, respectively, and 24-month PFS and OS rates of 61.7% and 83.0%.
- The company reiterates its planned 2026 commercial launch for anito-cel, which is partnered with Kite, a Gilead Company.
Dec 8, 2025, 9:25 PM
Arcellx Provides Update on Anito-cel Commercial Launch and Clinical Development
ACLX
Product Launch
New Projects/Investments
- Arcellx is preparing for the commercial launch of its CAR T therapy, anito-cel, with market entry expected next year and the Biologics License Application (BLA) submission described as imminent.
- The company emphasizes anito-cel's differentiated efficacy and safety profile compared to existing CAR T therapies and bispecifics, positioning it as a new class of CAR T with potential for broad adoption.
- Clinical trial updates include the full enrollment of Anito-First, a Phase 2 safety lead-in for the frontline study iMMagine-4, and the planned iMMagine-5 study post-approval to engage the community.
- Arcellx has engaged 82% of Authorized Treatment Centers (ATCs) via pre-approval information exchange, indicating readiness for launch.
Dec 7, 2025, 1:00 AM
Arcellx Reports Positive Phase 2 Data for Multiple Myeloma Therapy
ACLX
New Projects/Investments
Product Launch
- Arcellx Inc. and Kite, a Gilead company, presented promising data from their pivotal Phase 2 iMMagine-1 study for anitocabtagene autoleucel (anito-cel) in patients with relapsed or refractory multiple myeloma.
- The study reported a 96% overall response rate, with 74% of patients achieving complete remission, and a strong safety profile with low rates of severe cytokine release syndrome and neurotoxicity.
- Minimal residual disease (MRD) negativity was achieved in 95% of evaluable patients, and progression-free survival (PFS) rates at 6, 12, and 18 months were 93.1%, 82.1%, and 67.4%, respectively.
- Analysts from Bank of America Securities and Morgan Stanley have maintained Buy ratings on ACLX stock, citing the compelling efficacy and safety data.
- Anito-cel is expected to launch in the fourth-line multiple myeloma market by 2026, with optimistic uptake projections.
Dec 6, 2025, 7:17 PM
Arcellx Reports Third Quarter 2025 Financial Results
ACLX
Earnings
Guidance Update
- Arcellx, Inc. reported $576.0 million in cash, cash equivalents, and marketable securities as of September 30, 2025, which is anticipated to fund its operations into 2028.
- Collaboration revenue for the third quarter ended September 30, 2025, was $4.9 million, a significant decrease from $26.0 million in the same period of 2024, primarily due to the completion of dosing and manufacturing in the iMMagine-1 trial.
- The company's net loss for Q3 2025 increased to $55.8 million, compared to a net loss of $25.9 million for Q3 2024.
- Research and development expenses decreased to $35.1 million in Q3 2025, while general and administrative expenses increased to $31.6 million.
Nov 5, 2025, 9:03 PM
Arcellx Reports Third Quarter 2025 Financial Results
ACLX
Earnings
Demand Weakening
Guidance Update
- Arcellx reported cash, cash equivalents, and marketable securities of $576.0 million as of September 30, 2025, which is anticipated to fund operations into 2028.
- Collaboration revenue for the third quarter of 2025 was $4.9 million, a significant decrease from $26.0 million in the same period of 2024, primarily due to the completion of dosing and manufacturing in the iMMagine-1 trial.
- The company's net loss for Q3 2025 was $55.8 million, an increase from a net loss of $25.9 million in Q3 2024.
- Research and development expenses decreased to $35.1 million in Q3 2025, while general and administrative expenses increased to $31.6 million for the same period.
Nov 5, 2025, 9:00 PM
Arcellx Provides Update on Anito-cel Development and Commercialization Plans
ACLX
Guidance Update
Product Launch
- Arcellx expects to launch its lead asset, Anito-cel, a BCMA-directed CAR-T for multiple myeloma, in mid to late 2026, targeting a $3.5 billion market in the fourth-line+ setting.
- The company reported strong efficacy data for Anito-cel from the iMMagine-1 study at EHA, including a 66% PFS rate at 18 months and a low 90s% MRD negativity rate, with a differentiated safety profile showing no cases of delayed neurotoxicity or immune-related enterocolitis with at least four months of follow-up.
- Arcellx ended Q2 with $538 million in cash, providing a runway that funds the company into 2028, covering the Anito-cel launch and substantial post-launch operations.
- The company is confident in the regulatory path for Anito-cel, citing the unmet need in multiple myeloma related to safety issues and access, and plans to file the Biologics License Application (BLA) late this year into early next year.
Sep 10, 2025, 5:05 PM
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