Gilead Acquires Arcellx for $7.8B to Advance Anito-cel in Multiple Myeloma

Gilead Sciences has agreed to acquire Arcellx for an implied equity value of $7.8 billion on Feb 23. The transaction gives Gilead full control of anitocabtagene autoleucel, known as anito-cel. Anito-cel is an investigational BCMA-directed CAR T-cell therapy for multiple myeloma. Gilead will pay $115 per share in cash at closing. Shareholders will also receive one contingent value right worth $5 per share upon milestone achievement. The boards of both companies have approved the deal. The companies expect to close the transaction in the second quarter of 2026, pending regulatory clearance and tender conditions.

Anito-cel BLA Accepted by FDA with December 2026 PDUFA Date

The U.S. Food and Drug Administration has accepted the biologics license application for anito-cel. The agency set a Prescription Drug User Fee Act action date of December 23, 2026. The application covers adult patients with relapsed or refractory multiple myeloma in the fourth-line setting. 

Clinical data support the filing from a Phase 1 study and the pivotal Phase 2 iMMagine-1 trial. Anito-cel has shown deep and durable responses in heavily pretreated patients. The therapy has also demonstrated a predictable and manageable safety profile. These data position anito-cel as a potential best-in-class CAR T therapy.

Gilead Accelerates Commercialization and Eliminates Profit Sharing

Gilead aims to accelerate development and global commercialization of anito-cel. The acquisition eliminates existing profit-sharing, milestone payments, and royalty obligations. The company believes full ownership will streamline decision-making and maximize long-term value. Gilead’s subsidiary Kite already co-develops and co-commercializes anito-cel with Arcellx. The deal consolidates operational control within Gilead’s oncology portfolio. The company expects the transaction to be accretive to earnings per share in 2028 and beyond, assuming FDA approval. 

“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,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences.

D-Domain CAR Platform Expands Next-Generation Cell Therapy Pipeline

Beyond anito-cel, Gilead gains access to Arcellx’s proprietary D-Domain CAR technology platform. The platform generates highly specific target-binding domains with enhanced affinity. These domains may support next-generation CAR T-cell and bispecific therapies. Gilead also sees potential applications in in vivo cell therapy programs. The BCMA D-domain binder could strengthen broader oncology and inflammation pipelines. 

“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,” said Rami Elghandour, Chairman and Chief Executive Officer, Arcellx. “We are fortunate to have found a world-class partner in Gilead, which has the expertise to carry forward Arcellx’s legacy.

Gilead currently owns approximately 11.5 percent of Arcellx’s outstanding shares. A wholly owned Gilead subsidiary will launch a tender offer for the remaining shares. The offer represents a 68 percent premium to Arcellx’s 30-day volume-weighted average price as of February 20, 2026. The contingent value right triggers if cumulative global net sales of anito-cel reach $6.0 billion by the end of 2029. If the tender succeeds, Gilead will complete a second-step merger for remaining shares.

Author

Steven Chung

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