Gilead's $7.8B Acquisition of Arcellx: The First Major Oncology Deal of 2026

In the world of innovative drugs, there are no permanent winners, only an unending gamble. And Gilead Sciences may be the most tragic player in the field of oncology mergers and acquisitions in recent years.

From a $4.9 billion bet on CD47 ending in total loss, to the $21 billion acquisition of Immunomedics with significantly diminished returns, and further to over $1 billion invested in the TIGIT field with slim hopes, Gilead Sciences' expansion path in the oncology sector is riddled with "misfortune" and "the harder they try, the more disappointing it gets."

Fortunately, thanks to its strong foundation in the antiviral field, these setbacks did not deter Gilead Sciences from pursuing further deals. On February 23, 2026, Gilead made another move by acquiring Arcellx for $7.8 billion, marking the first major acquisition in the oncology sector this year.

Arcellx's BCMA CAR-T therapy, anito-cel, is set to face an FDA approval decision in the second half of this year. Gilead Sciences has high hopes for anito-cel, considering its emphasis on safety as a key advantage, positioning it as a Best-in-Class (BIC) product. With Kite’s established large-scale production capabilities and extensive CAR-T commercialization network, anito-cel is well-positioned to compete in the nearly $100 billion CAR-T market.

However, in the face of the already risen Carvykti and Johnson & Johnson's vast myeloma treatment empire built around Darzalex, is this new high-stakes gamble a lifeline for Gilead Sciences to reverse its fortunes, or the beginning of another costly misstep?

/ 01 / The "Worst Player" in Tumor M&A

In Gilead Sciences' development history, its achievements in the antiviral field once brought it immense success. The triumph of its hepatitis C and HIV drugs significantly bolstered the company’s revenue. However, the market contraction of its core hepatitis C business has forced Gilead Sciences to seek new avenues for growth.

Turning the clock back seven years to when Gilead CEO Daniel O'Day took office, the company was facing the severe challenge of consecutive revenue declines. To reshape the growth curve, he decisively shifted the strategic focus to areas such as oncology and led a series of major acquisitions that were nothing short of bold gambles.

However, looking back at its track record, it is hard to call it a success, and it has even sparked widespread doubts about its decision-making capabilities. The biggest lesson came from the acquisition of Immunomedics. In 2020, Gilead Sciences spent a staggering $21 billion to acquire the ADC drug Trodelvy, aiming to expand into the solid tumor field. However, things did not go as planned. Trodelvy subsequently failed in key clinical trials, making it highly likely that this huge investment will not be recouped.

Despite a 6% year-over-year increase in Trodelvy sales to approximately $1.4 billion in 2025, recovering the exorbitant costs remains far out of reach.

This is not an isolated case. In the CD47 target, Gilead invested $4.9 billion, only to lose everything. In the TIGIT field, once regarded as the next hope for tumor immunotherapy, Gilead paid over $1 billion to Arcus Biosciences, yet faced repeated clinical failures. At the end of last year, due to the failure of domvanalimab in Phase 3 clinical trials, Arcus decided to terminate its collaborative research with Gilead and shift the company’s R&D strategic focus.

In the past few years, Gilead Sciences has spent tens of billions on mergers, acquisitions, and R&D in the oncology field, only to face a series of pipeline failures and stagnant revenue. This has inevitably led investors to question Daniel O'Day's acumen in mergers and acquisitions, with some even deeming Gilead’s track record in oncology deals during his tenure as "highly questionable."

Interestingly, despite repeated setbacks, Gilead Sciences has not abandoned its pursuit of growth through mergers and acquisitions, thanks to its robust HIV business foundation — by 2025, related business sales are expected to reach approximately $20.8 billion, a 6% year-over-year increase, with its flagship drug Biktarvy generating $14.3 billion in sales.

This "never give up despite failure" trait reappeared in the acquisition of Arcellx on February 23, 2026.

/ 02 / Gilead Sciences Continues Bold Gamble

Gilead Sciences' dedication to CAR-T therapy began with the $11.9 billion acquisition of Kite in 2017.

This deal enabled the company to acquire the approved CD19 CAR-T therapy Yescarta in one fell swoop, propelling it to become a global leader in cell and gene therapy. Yescarta once basked in glory, with sales reaching $1.57 billion in 2023, solidifying Gilead Sciences' position at the top of the CAR-T market.

However, the good times did not last long. As market competition intensified, particularly with Bristol-Myers Squibb's Breyanzi and other competing products rapidly gaining market share due to their safety advantages, Gilead Sciences' CAR-T therapy growth began to show signs of fatigue.

On the CD19 CAR-T battlefield, Gilead Sciences' first-mover advantage is being eroded. Therefore, it has set its sights on another promising target—BCMA—and the then-rising star, Arcellx.

In December 2022, Gilead Sciences, through its subsidiary Kite, entered into a collaboration with Arcellx, paying an upfront fee of $225 million and up to $3.9 billion in milestone payments to gain co-development rights for the BCMA CAR-T product anito-cel. At that time, anito-cel was only in Phase II clinical trials, but its early demonstrated 100% ORR data was impressive.

11 Months Later, Gilead Doubles Down Again, Paying $85 Million in Cash and $200 Million in Equity Investment to Secure the Core Technology Behind Anito-cel's Artificial BCMA Binding Domain. Arcellx Overcomes Some Limitations of Traditional Cell Therapy by Designing a New Class of D-Domain-Driven Autologous and Allogeneic CAR-T Cells, Including the Classic Single-Infusion CAR-T (referred to as ddCARs).

Two years of continuous investment demonstrates Gilead's high expectations for this drug, and the latest full acquisition has pushed these expectations to a peak. The $7.8 billion deal also marks the first major acquisition in the oncology field in 2026.

Gilead Sciences' confidence stems from the high recognition of anito-cel. Last year, Arcellx disclosed follow-up data from the iMMagine-1 trial, showing that as of May 1, among 117 patients with a median follow-up of 12.6 months, the ORR was 97%, the CR/sCR rate was 68%, and the 6-month PFS and OS were 91.9% and 96.6%, respectively. The 12-month PFS and OS rates were 78.8% and 95.2%, respectively, with the median PFS and median OS not yet reached.

In terms of safety, Arcellx stated that no additional treatment or therapy-related deaths or ≥3 grade CRS or ICANS events have occurred since the last data presentation in December 2024.

This BCMA CAR-T therapy, which highlights safety, is regarded by Gilead as a BIC (Best-in-Class) product. Combined with Kite's mature large-scale production capabilities and well-established CAR-T commercialization network, Gilead is confident that anito-cel has the potential to compete in the nearly billion-dollar CAR-T market. However, the market's confidence in Arcellx appears to have wavered.

In November 2024, Arcellx's stock price once reached a high of $107 per share, but due to the lack of significant progress at the 2025 ASH meeting, combined with the core competitor Carvykti becoming a blockbuster drug for multiple myeloma, its stock price fell by 30% between November and December.

It was not until two months later that Gilead Sciences announced the acquisition of Arcellx at $115 per share.

/ 03 / Me-too or BIC

To outsiders, facing fierce competition and with anito-cel still at least 10 months away from approval, Arcellx’s acceptance of Gilead Sciences' acquisition is undoubtedly a "prudent exit." The contingent value right of $5 per share in the deal also adds an extra gain for shareholders.

However, the realization of this right requires Anito-cel to achieve cumulative sales of $6 billion by the end of 2029. Whether this can be achieved depends first on the FDA's approval for late-stage indications, which is relatively certain; secondly, on the strong market acceptance brought by its claimed safety advantages; and subsequently on its expansion to earlier treatment lines, which is the biggest unknown and the main battleground where Anito-cel must prove itself.

It should be noted that Carvykti is not its only competitor, as Johnson & Johnson's BCMA/CD3 bispecific antibody Tecvayli is also about to undergo FDA review.

In December last year, data from the MajesTEC-3 trial confirmed that the combination therapy of Tecvayli and Darzalex significantly outperformed traditional combination therapies in patients with multiple myeloma who had previously received one to three lines of treatment. It reduced the risk of death by 54% and demonstrated a progression-free survival benefit as high as 83%. Based on these results, the FDA has granted Johnson & Johnson priority review status.

Interestingly, prior to this, Arcellx had only disclosed that anito-cel's application had been submitted and anticipated that the FDA would make a decision in the second half of this year. Recently, it revealed that the PDUFA date is December 23, which means the BLA did not receive priority review, suggesting that, at least for now, the FDA does not consider anito-cel to have any particular distinguishing features warranting expedited approval.

This also means that, for Gilead Sciences, this $7.8 billion acquisition is no less than another high-stakes gamble.

On the one hand, despite Arcellx CEO repeatedly claiming in public that anito-cel is the best in its class and Gilead Sciences showing strong confidence in its potential, the market clearly remains unconvinced.

The core reason behind this might be that the current anito-cel is more of a "me too" product rather than the Best-in-Class (BIC), and it cannot compete with Carvykti. Arcellx has repeatedly emphasized its safety advantages, but there were three deaths in the iMMagine-1 trial, one of which was related to CRS. It remains to be seen whether anito-cel can maintain its consistent safety profile as clinical trials expand in scale and duration.

In terms of efficacy, it is difficult for anito-cel to prove its OS benefit, so the focus will be on its PFS data in the future. The CARTITUDE-1 data shows that Carvykti’s median PFS is 34.9 months, and CARTITUDE-1 involves a higher number of treatment lines. From this perspective, the market believes that iMMagine-1 should have a relatively rigid standard in terms of efficacy.

In response to market concerns about PFS, during the previous ASH investor communication, Professor Ciara L. Freeman specifically mentioned when introducing the iMMagine-1 study: By extending the follow-up period, the median progression-free survival (PFS) of treated patients reached 34 months.

In other words, with effort, anito-cel might achieve efficacy comparable to Carvykti. However, in the eyes of the market, if it cannot demonstrate significant clinical advantages, anito-cel remains a follower.

On the other hand, Johnson & Johnson has long established an unshakable moat in the multiple myeloma field, stating that 80% of patients use at least one of Johnson & Johnson's drugs during treatment. Johnson & Johnson not only owns Darzalex, which has been on the market for many years but still remains in a growth cycle with annual sales exceeding $14 billion; it has also built a comprehensive treatment ecosystem around Darzalex. Bispecific antibodies like Carvykti and Tecvayli have become core extensions of this ecosystem. The former has treated over 10,000 patients across 14 markets, with projected sales reaching $1.887 billion in 2025, representing a year-on-year increase of 95.95%.

In this situation, newcomers must be good enough to shake the dominant position. If they only manage to tie or achieve a limited victory, breaking through will not be easy.

Of course, Arcellx Chief Medical Officer Chris Healy once said, everyone is asking us, won't it be very difficult to compete with Johnson & Johnson and Legend Biotech?

He believes that Johnson & Johnson also indicated that with its production capacity, it may only be able to capture about half of the market share, leaving room for another competitor. The CAR-T multiple myeloma market for second-line and above treatments could eventually be worth $12 billion, and if CAR-T therapy moves into first-line treatment, the market size might be even larger.

However, Arcellx chose to sell itself just before the finish line.

Ultimately, whether it's "me too" or BIC will determine if anito-cel can carve out a niche in the competition against Johnson & Johnson and Legend Biotech. This not only dictates the evolution of the BCMA CAR-T and multiple myeloma market landscape but also concerns whether Gilead Sciences can, through this bold gamble, shake off years of misfortune and truly "win again" in the oncology field.

       Title: The First M&A Case in the Oncology Field in 2026: A High-Stakes Gamble