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.
Kite and Arcellx have announced a global collaboration to co-develop the CART-ddBCMA therapy for relapsed or refractory multiple myeloma. Kite will provide an upfront payment of $225 million and a $100 million equity investment. The companies will share development and commercialization costs, splitting U.S. profits 50/50. The partnership aims to address the significant unmet need in multiple myeloma treatment.
The transaction is expected to close in Q1 2023 and may reduce Gilead's EPS by approximately $0.16. The collaboration capitalizes on Kite's leadership in cell therapy and Arcellx's innovative approach.
Arcellx (NASDAQ: ACLX) reported promising long-term results from the CART-ddBCMA Phase 1 expansion trial, where 100% of patients achieved an overall response rate. Of 38 evaluable patients, 71% reached complete or stringent complete response (CR/sCR). No severe toxicities were noted at the recommended Phase 2 dose of 115 million CAR+ T cells. Additionally, the company initiated the iMMagine-1 Phase 2 trial and the Phase 1 trial for ACLX-002 targeting acute myeloid leukemia and myelodysplastic syndromes. The developments indicate a strong commitment to advancing innovative cancer therapies.
Arcellx and Kite, a Gilead Company, have entered into a strategic collaboration to co-develop and commercialize CART-ddBCMA, a late-stage cell therapy for relapsed or refractory multiple myeloma. Arcellx will receive an upfront payment of $225M, a $100M equity investment, and potential contingent payments up to $3.9B. The companies will share U.S. profits 50/50 while Arcellx earns royalties on sales outside the U.S. The collaboration aims to accelerate patient access to innovative therapies.
Arcellx, Inc. (NASDAQ: ACLX) reported its third-quarter 2022 financial results, highlighting the initiation of the pivotal iMMagine-1 Phase 2 study for CART-ddBCMA aimed at treating relapsed multiple myeloma. The company has $280.8 million in cash, sufficient to fund operations for the next 12 months. R&D expenses surged to $83.5 million, primarily due to a one-time $63.1 million non-cash expense related to Lonza manufacturing services. The net loss for the quarter was $92.9 million, marking a significant increase from $17.1 million in Q3 2021.
Arcellx, Inc. (ACLX) announced significant developments in its Q2 2022 financial results and business highlights. The company completed a public offering raising $128.8 million and presented promising data from its CART-ddBCMA Phase 1 trial at the ASCO Annual Meeting, reporting a 100% overall response rate. Cash reserves as of June 30, 2022, stood at $307 million. However, the company incurred a net loss of $32.1 million, up from $15.9 million a year earlier, driven largely by increased R&D expenses.
Arcellx, Inc. (NASDAQ: ACLX) has appointed Maryam Abdul-Kareem, J.D., as General Counsel, bringing extensive experience in the biopharmaceutical industry from her previous roles at Kinnate Biopharma and AstraZeneca. Abdul-Kareem's responsibilities will include overseeing legal, contracts, and compliance matters as the company scales its operations. CEO Rami Elghandour emphasized her leadership skills and commitment to diversity as vital for the company’s growth.
Arcellx is focused on developing innovative immunotherapies for cancer and related diseases, including its lead candidate CART-ddBCMA.
Arcellx, Inc. (NASDAQ: ACLX) has successfully closed its upsized public offering, raising $128.8 million through the sale of 8,050,000 shares of common stock at $16.00 per share. This includes the full exercise of an option by underwriters to purchase an additional 1,050,000 shares. The offering, which was registered with the SEC and became effective on June 15, 2022, aims to advance Arcellx's innovative immunotherapies, including CART-ddBCMA for multiple myeloma and ARC-SparX for various cancers.
Arcellx, Inc. (NASDAQ: ACLX) announced a follow-on public offering of 7,000,000 shares at $16.00 per share, raising $112 million in gross proceeds. This offering is an increase from the initial size of 4,000,000 shares. Underwriters have a 30-day option to purchase an additional 1,050,000 shares. The offering is set to close on June 21, 2022. BofA Securities, SVB Securities, William Blair, and Canaccord Genuity are acting as joint book-running managers.
Arcellx, Inc. (NASDAQ: ACLX) presented promising Phase 1 results for its CART-ddBCMA therapy targeting relapsed or refractory multiple myeloma. Among 31 evaluable patients, a 100% overall response rate was observed, with 71% achieving complete (CR) or stringent complete (sCR) responses. Notably, long-term data showed that 81% of patients dosed over 12 months reached CR/sCR. The treatment was well-tolerated, with no severe toxicities reported. A pivotal Phase 2 study is expected to initiate by the end of 2022. These findings highlight the therapy's potential as a leading treatment option.
Arcellx, Inc. (NASDAQ: ACLX) has appointed Michelle Gilson as the new Chief Financial Officer. Gilson previously served as a Managing Director and Senior Equity Research Analyst at Canaccord Genuity, specializing in biotechnology. Her extensive background in capital markets will enhance Arcellx's financial strategy as they advance their innovative cell therapies aimed at treating cancer. The lead product candidate, CART-ddBCMA, is in an ongoing Phase 1 study and has received multiple FDA designations, underscoring the company's commitment to developing effective treatment options.