Wells Fargo Bets on Arcellx (ACLX.US) to Reshape Myeloma Treatment Landscape, Foresees Over 50% Stock Upside

SmartCom APP learned that Wall Street financial giant Wells Fargo initiated coverage and target price for the U.S. biotech newcomer Arcellx (ACLX.US), rating it as "Overweight." Wells Fargo stated that Arcellx’s experimental CAR-T therapy “anito-cel” for multiple myeloma is a "future pillar" in the management system of this blood cancer, which will reshape the treatment landscape of myeloma in the future.

More significantly, Wells Fargo's robust target price for Arcellx serves as a major boost for the global innovative drug sector currently in a pullback phase. Wells Fargo has set a target price of $100 for Arcellx — indicating that, in the bank’s view, the biotech newcomer’s stock has a potential upside of up to 53% from Monday’s closing price. Arcellx’s stock performance this year has been lackluster, with a decline of over 15% year-to-date, significantly underperforming the S&P 500 Index.

Senior analyst Yanan Zhu from Wells Fargo stated that he believes "based on its attractive efficacy and safety profile compared to peers, anito-cel can expand and capture the majority share in the 4L+ BCMA CAR-T market for multiple myeloma (MM), outcompeting currently approved products," adding that he expects the therapy to see rapid adoption upon its anticipated launch in 2026.

The analyst pointed out that anito-cel is expected to receive formal approval in the second-line setting by 2028, and possibly earlier, which would significantly drive sales towards a stronger growth trajectory.

Arcellx is co-developing anito-cel with Kite Pharma, which is owned by U.S. healthcare leader Gilead Sciences (GILD.US).

Analyst Yanan Zhu stated that peak sales in the fourth-line (4L) setting are projected to reach $1.6 billion (with approximately $690 million attributed to Arcellx), and around $3.8 billion upon securing second-line or higher (second-line+) approval (with an estimated $1.5 billion attributed to Arcellx).

Despite the strong recent Phase 3 clinical trial data for Tecvayli (teclistamab) combined with Darzalex (daratumumab) in multiple myeloma, an analyst at Wells Fargo, Zhu, pointed out that around 30% of patients in second-line treatment settings exhibit extreme resistance to Darzalex, making them ineligible for the Tec-Dara combination regimen.

Anito-cel——May Disrupt the Treatment Landscape for Multiple Myeloma

Arcellx (NASDAQ: ACLX) is a clinical-stage biotechnology company focused on developing innovative cell therapy products for cancer (and extending to certain autoimmune indications) based on its proprietary D-Domain (synthetic binding domain) technology platform. The company is considered a late-stage clinical newcomer/key player in the cell therapy field, but its commercial expansion prospects remain highly dependent on the potential approval and market launch of its "pipeline of innovative drug candidates," such as the formal regulatory approval and commercial-scale rollout of its lead innovative drug candidate, anito-cel.

Anito-cel (anitocabtagene autoleucel, formerly known as CART-ddBCMA) is a BCMA-targeted autologous CAR-T cell therapy for relapsed/refractory multiple myeloma; co-developed and commercialized with Kite Pharma (a subsidiary of Gilead).

In the eyes of analysts from well-known sell-side institutions such as Wells Fargo, anito-cel is expected to completely disrupt the current treatment landscape for multiple myeloma. The core mechanism of anito-cel remains the typical CAR-T logic: modifying patient T cells ex vivo to express chimeric antigen receptors that recognize BCMA (a common target on myeloma cells); after reinfusion, CAR-T identifies and attacks myeloma cells. However, the differentiation of anito-cel enables the drug to achieve high response rates with relatively controllable safety. Anito-cel incorporates a novel, compact D-Domain binding domain from Arcellx as a key component (representing a design innovation).

The differentiated design of anito-cel lies in the use of Arcellx's D-Domain (a small, stable binding domain) as the "recognition head." Materials from Kite/Gilead state that it can achieve higher CAR expression, reduce/avoid "tonic signaling (spontaneous signaling without antigen stimulation)," and is designed to release more quickly after binding to the target. Its goal is to maintain killing efficacy while reducing the probability of severe immunotoxicity (such as severe CRS/ICANS). For instance, in the disclosed data from iMMagine-1, CRS was mostly low-grade, with a relatively lower incidence of ICANS.

Therefore, if anito-cel, launched by Arcellx, is approved for later-line treatment in 2026 as expected by the seller's market, and achieves rapid penetration with its "efficacy + safety" advantages, it may alter the ranking and market share distribution of BCMA-targeted therapies (such as CAR-T and bispecific antibodies) in the later-line treatment of multiple myeloma. The latest sell-side view from Wells Fargo even refers to it as one of the future "pillars" of treatment.