Gilead Sciences has agreed to acquire Arcellx for $7.8 billion, the companies said today, in a deal intended to give the buyer full control of the buyout target’s lead candidate, a BCMA-directed chimeric antigen receptor (CAR) T-cell therapy for multiple myeloma that Arcellx and a Gilead subsidiary have spent the past 3+ years partnering to co-develop and co-commercialize.
The CAR T therapy candidate, anitocabtagene autoleucel (anito-cel), is the subject of a Biologics License Application (BLA) that is under FDA review, with a target decision date of December 23 under the Prescription Drug User Fee Act (PDUFA).
The BLA would position anito-cel as a fourth-line treatment for patients with relapsed or refractory multiple myeloma. The application is supported by data from a Phase I study (NCT04155749) and the pivotal Phase II iMMagine1 trial (NCT05396885).
If approved, anito-cel would emerge as a head-on competitor to Johnson & Johnson/Legend Biotech’s Carvykti® (ciltacabtagene autoleucel), the BCMA-directed CAR T-cell therapy indicated for adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. Carvykti generated $1.877 billion in sales last year, up nearly double (96%) from $963 million in 2024.
Kite, a Gilead Company, and Arcellx agreed to partner on the development of anito-cel in December 2022, through a collaboration that was designed to generate potentially more than $4 billion for Arcellx.
Under that original agreement and a 2023 amendment to that partnership, Arcellx was eligible to receive additional clinical, regulatory, and commercial milestone payments totaling up to $530.0 million for anito-cel, up to $935.0 million for each next-generation autologous CAR T cell therapy product, and up to $507.5 million for each non-autologous CAR T cell therapy product generated by the companies.
In 2024, Arcellx received $68.3 million from Kite for achieving a clinical milestone for anito-cel related to enrollment in the iMMagine-1 trial.
Arcellx investors roared their approval of Gilead’s planned acquisition of the company with a buying surge that sent it shares soaring 78% to $113.86 in early morning trading as of 11:52 a.m. ET. Gilead shares dipped 1% to $149.86.
Positive clinical results
Anito-cel has generated positive pivotal clinical trial results, with Gilead most recently in December announcing data from an October 7, 2025, cutoff date of 117 patients followed for a median of 15.9 months after treatment with the cell therapy in iMMagine-1. The data showed an independent review committee (IRC)-assessed overall response rate (ORR) of 96%, with 74% achieving a stringent complete response or complete response (sCR or CR) per International Myeloma Working Group (IMWG) criteria.
And of the 96 patients evaluable for minimal residual disease (MRD) testing, 91 (95%) achieved MRD negativity at a median of one month, meaning no cancer cells could be detected even with highly sensitive tests (≤10-5 sensitivity). Progression-free survival (PFS) rates were 82.1% at 12 months, 67.4% at 18 months and 61.7% at 24 months.
In demonstrating what Gilead and Arcellx have said were deep and durable responses with a predictable and manageable safety profile, anito-cel is designed to address key challenges associated with current CAR T-cell therapies in multiple myeloma.
“This agreement reflects our conviction in the potential of anito-cel and our intention to move with speed so we can make the most of that potential for patients with multiple myeloma,” Daniel O’Day, Gilead’s chairman and CEO, said in a statement. “Beyond the potential launch this year, anito-cel could become a foundational treatment for multiple myeloma over time, including earlier lines of therapy.”
O’Day added that the anito-cel’s D-domain BCMA binder “could be important to our work in in vivo cell therapy, further strengthening our potential in oncology and inflammation.”
Gilead reasons that the D‑domain BCMA binder and Arcellx’s broader D-Domain CAR technology platform could potentially be used for next-generation in vivo CAR T-cell and bispecific therapies.
“While we believe the deal was largely motivated by Gilead’s confidence in anito-cel and desire to participate entirely in this economic potential of anito-cel without the burden of future collaboration-related payouts, we believe the company also saw long-term value in Arcellx’s D-Domain and ARC-SparX platforms, further supporting the acquisition premium,” Corwin commented.
GEN ‘Takeover Target’
The acquisition ends speculation about Arcellx being a buyout candidate—speculation that was wide enough last year for Arcellx to have been included in GEN’s A-List of Top 10 Takeover Targets of 2025. The takeover talk was based on earlier positive clinical data for anito-cel plus Gilead taking ownership of approximately 11.5% of Arcellx’s outstanding common stock.
Gilead’s deal to acquire Arcellx was approved by the boards of both companies, and is expected to close during the second quarter, subject to the satisfaction or waiver of customary closing conditions that include the tender of a number of shares of Arcellx common stock that, together with shares already owned by Gilead, equals at least a majority of the then-outstanding Arcellx shares, the receipt of regulatory approvals and other customary offer conditions.
Gilead agreed to acquire Arcellx for $115 per share in cash at closing—79% above Arcellx’s closing share price Friday of $64.11 and a 68% premium to Arcellx’s 30-day volume-weighted average share price as of February 20—plus one non-transferable contingent value right of $5 per share. The CVR is tied to Gilead achieving cumulative global net sales of anito-cel of at least $6 billion from launch through the end of 2029.
Should the tender offer be successfully completed, Gilead will acquire all remaining shares of Arcellx not tendered in the offer through a second step merger for the same consideration as is paid in the tender offer.
Gilead said that upon FDA approval of anito-cel, the proposed acquisition deal is expected to add to its earnings per share in 2028 and thereafter.
“The story of Arcellx is one of innovation, passion, resilience and teamwork. I could not be prouder of our team, our contribution to the myeloma field, and the impact anito-cel and our D-Domain platform are poised to have for patients and clinicians,” stated Rami Elghandour, Arcellx’s chairman and CEO.
“We are fortunate to have found a world-class partner in Gilead, which has the expertise to carry forward Arcellx’s legacy. Kite is well-positioned to maximize access to anito-cel, benefiting more patients, and the company’s commitment to be the leader in cell therapy is one I admire,” Elghandour added.
