Anitocabtagene autoleucel

Gilead Sciences has struck a deal to buy Arcellx for $7.8 billion to take full control of a CAR-T cell therapy that is on the cusp of approval. Arcellx partnered with Gilead to develop the BCMA-directed CAR-T anitocabtagene autoleucel (anito-cel) in 2022. Gilead invested in Arcellx as part of the agreement and, having invested again when amending the deal in 2023, owns 11.5% of the company. With Gilead on the hook for $530 million in milestones for anito-cel, analysts had speculated about a potential buyout. Gilead made its move Monday, agreeing to pay $115 per share in cash for Arcellx. The offer represents a 68% premium to Arcellx’s 30-day volume-weighted average share price. Arcellx shareholders will receive another $5 per share if cumulative global anito-cel sales hit $6 billion by the end of 2029. Gilead CEO Daniel O’Day discussed the buyout in a statement. “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,” O’Day said. “Beyond the potential launch this year, anito-cel could become a foundational treatment for multiple myeloma over time, including earlier lines of therapy.” The FDA is reviewing a filing for approval of anito-cel as a fourth-line treatment for relapsed or refractory multiple myeloma. Gilead applied for priority review, but the Dec. 23 PDUFA date suggests the FDA will assess the filing under its standard pathway. The FDA approved Johnson & Johnson and Legend Biotech’s BCMA-directed CAR-T cell therapy Carvykti in 2022, and it's since attained blockbuster status. But, after speaking to physicians treating multiple myeloma patients, Guggenheim Securities analysts recently said in a note to investors that anito-cel is preferred to the incumbent. The preference reflects the therapies’ safety profiles. Gilead acquired cell therapy operations through its $11.9 billion Kite Pharma takeover in 2017 and sells the CD19-directed treatments Tecartus and Yescarta. The unit has struggled, though, with Gilead’s cell therapy sales falling 7% to $1.8 billion last year. BMO Capital Markets analysts said in a recent note to investors that the anito-cel launch could help Gilead’s cell therapy unit “regain its footing.” Analysts with William Blair viewed the deal terms “favorably,” citing the offer's premium on Arcellx's share price and the strong likelihood that Arcellx will collect the contingent value right tied to anito-cel, according to a Feb. 23 note. The analysts also believe Gilead saw long-term value in Arcellx’s other platforms, as demonstrated in the acquisition premium. The content above comes from the network. if any infringement, please contact us to modify.