Gilead to Acquire Arcellx to Secure Anito-cel’s Long-Term Potential

Lead

Gilead Sciences has agreed to buy Arcellx for $115 per share in cash plus one contingent value right (CVR) worth $5 on achievement of a sales milestone, valuing the deal at about $7.8 billion at close. The move gives Gilead full control of anito-cel, a BCMA-directed CAR T candidate for relapsed/refractory multiple myeloma whose BLA has been accepted by the FDA with a PDUFA date of December 23, 2026. The transaction, approved by both companies’ boards, is expected to close in the second quarter of 2026 subject to customary conditions and sufficient tendered shares. Gilead said bringing the program fully in‑house will accelerate development, commercialization and patient access while eliminating profit‑share and royalty obligations.

Key Takeaways

• Deal terms: $115 per share cash plus one non‑transferable CVR worth $5 if cumulative anito‑cel global net sales reach at least $6.0 billion through 2029.
• Implied value: the offer represents an implied equity value of approximately $7.8 billion payable at closing and a 68% premium to Arcellx’s 30‑day VWAP as of Feb 20, 2026.
• Regulatory status: FDA has accepted the BLA for anito‑cel as a fourth‑line treatment for relapsed/refractory multiple myeloma; anticipated PDUFA action date is Dec 23, 2026.
• Ownership and process: Gilead currently holds ~11.5% of Arcellx and will launch a tender offer followed, if necessary, by a second‑step merger to acquire remaining shares.
• Financial outlook: Gilead expects the acquisition to be accretive to earnings per share beginning in 2028, contingent on FDA approval and successful commercialization.
• Technology: Arcellx’s D‑Domain CAR platform, including a D‑domain BCMA binder, is highlighted as a potential asset for next‑generation CAR‑T, bispecifics and in vivo cell therapy research.

Background

Arcellx is a clinical‑stage biotech developing cell therapies centered on its proprietary D‑Domain CAR technology. Its lead candidate, anitocabtagene autoleucel (anito‑cel), targets BCMA and has been advanced through a Phase 1 study (NCT04155749) and the pivotal Phase 2 iMMagine1 trial (NCT05396885). Kite, a Gilead company, and Arcellx previously struck a 2022 collaboration to jointly develop and commercialize anito‑cel, reflecting strategic alignment between the teams prior to this acquisition.

Multiple myeloma remains an area of high unmet need: despite therapeutic advances, many patients eventually relapse and become refractory to approved regimens. Current CAR‑T options have shown transformative outcomes for some patients, but obstacles such as durability of response, toxicity management and access persist—issues that both companies cite as motivators for advancing anito‑cel and the underlying D‑Domain platform.

Main Event

Gilead announced a definitive agreement to acquire Arcellx for $115 per share in cash plus one CVR potentially worth $5, with the transaction carrying an implied equity value of about $7.8 billion at closing. The boards of both companies approved the merger agreement, and a wholly‑owned Gilead subsidiary will commence a tender offer for Arcellx shares Gilead does not already own.

The CVR payment is contingent on cumulative global net sales of anito‑cel reaching at least $6.0 billion from launch through year‑end 2029. If the tender offer is completed, any remaining public shares will be acquired via a second‑step merger on the same economic terms. Closing is targeted for Q2 2026, subject to customary conditions including regulatory clearances and sufficient shareholder participation.

Gilead emphasized that taking full control of anito‑cel removes profit‑sharing, milestone and royalty arrangements tied to the prior collaboration and should allow Kite and Gilead to streamline development, manufacturing scale‑up and commercialization plans. The company noted an expectation that the acquisition will be accretive to adjusted EPS starting in 2028 if and when anito‑cel receives FDA approval.

Analysis & Implications

Strategic rationale: the deal consolidates a late‑stage cell therapy program into Gilead’s oncology franchise, strengthening Kite’s pipeline and giving Gilead exclusive rights to the D‑Domain binder technology. Full ownership simplifies decision‑making on indications, manufacturing investments and pricing strategies—critical in a category where scale and speed to market influence competitive positioning.

Commercial prospects: anito‑cel’s BLA acceptance and the Dec 23, 2026 PDUFA date create a near‑term binary event that drives deal value. If approved and launched, sales performance through 2029 will determine the CVR payout and materially affect deal economics. Market uptake will depend on comparative safety, durability versus existing BCMA therapies, reimbursement and the ability to expand into earlier lines of therapy.

Financial and integration risks: achieving the projected accretion in 2028 presumes timely approval, successful manufacturing scale‑up and effective commercialization. Integration risk—aligning Arcellx assets, employees and operations with Gilead/Kite—remains a common post‑deal challenge. Additionally, regulatory or antitrust reviews could delay closing or impose conditions.

Broader R&D implications: the D‑Domain platform’s potential utility beyond anito‑cel—such as in bispecific antibodies or in‑vivo cell therapy programs—could yield incremental value over time. That optionality likely contributed to Gilead’s willingness to pay a significant premium and to pursue outright ownership rather than continuing a profit‑share collaboration.

Comparison & Data

The table summarizes the transaction mechanics and key regulatory milestones. The 68% premium underscores Gilead’s eagerness to secure full program rights; the CVR structure balances upfront cash against later commercial performance, effectively sharing some execution risk with Arcellx shareholders. Investors should track the tender offer materials and subsequent SEC filings for granular financial modeling inputs.

Reactions & Quotes

Following the announcement, both CEOs framed the transaction as a win for patients and science while noting the next regulatory steps. Observers in biotech and capital markets highlighted the premium and the deal’s reliance on an upcoming regulatory decision.

“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, Chairman & CEO, Gilead Sciences (company statement)

Gilead positioned the acquisition as a way to accelerate development and broaden access, pointing to Kite’s cell‑therapy infrastructure as a scale platform for anito‑cel.

“We are fortunate to have found a world‑class partner in Gilead, which has the expertise to carry forward Arcellx’s legacy.”

Rami Elghandour, Chairman & CEO, Arcellx (company statement)

Arcellx leadership framed the deal as recognition of their scientific progress and a route to deliver therapies to more patients. Market participants and analysts will watch tender participation rates and any competing bids as indicators of shareholder sentiment.

Unconfirmed

• The precise timeline for manufacturing scale‑up and commercial launch preparations under Gilead/Kite has not been disclosed and remains subject to internal planning and regulatory interactions.
• Any potential regulatory or antitrust reviews and their conditions (if any) that could affect closing timing or deal terms are not yet public.

Bottom Line

Gilead’s acquisition of Arcellx is a strategic bet on anito‑cel and the D‑Domain platform, consolidating late‑stage cell‑therapy IP into an established commercial and manufacturing organization. The deal structure—cash plus a performance‑linked CVR—reflects a balance between immediate value for Arcellx shareholders and contingent pay‑outs tied to commercial success.

Near term, the outcome of the FDA’s PDUFA decision on Dec 23, 2026, and the pace of tender offer acceptance will determine whether the transaction closes as planned in Q2 2026 and how quickly Gilead can integrate the program. For patients and clinicians, the acquisition could meaningfully change access and rollout timelines if approval and commercialization proceed smoothly; for investors, the CVR and timing to projected accretion in 2028 are key variables to monitor.

Sources

• Gilead Sciences press release (official company announcement)
• Arcellx SEC filings and investor materials (regulatory / investor disclosures)
• NCT04155749 — Phase 1 study (anito‑cel) (clinical trials registry)
• NCT05396885 — iMMagine1 Phase 2 study (anito‑cel) (clinical trials registry)