More than four years after its CAR-T star Carvykti’s initial FDA approval, Legend Biotech has reached a major milestone, posting its first profitable quarter.
The company recorded $63 million in adjusted net income for the second quarter, bouncing into the black for the first time following a $10.5 million net loss in the first three months of 2026. Driven by strong demand for Carvykti, Legend expects to sustain profitability through the second half of 2026.
Legend’s swing to profitability comes amid a surprise leadership transition. Ying Huang, Ph.D., the CEO who shepherded Carvykti’s launch, resigned in late July to lead upstart K2 Therapeutics. On an interim basis, the CEO baton was passed to Alan Bash, who has been president of Carvykti since 2024.
“As the interim CEO, my focus is really on maintaining our focus on execution and delivering on our priorities, which are specifically around growing Carvykti and accelerating our pipeline,” Bash said in an interview with Fierce Pharma.
In the search for a permanent replacement, Legend’s board is avoiding a deadline to focus on “looking at various qualities that would provide for the best long-term leader given the stage of the growth of the company,” Bash said on Legend’s earnings call Tuesday.
Despite the hard-won corporate profitability and strong 50% year-over-year sales growth, Carvykti faces several challenges. The rise of off-the-shelf bispecifics threatens to complicate Legend’s partnership with Johnson & Johnson, while Gilead Sciences’ expected entry with anito-cel poses a fresh autologous rival. Compounding those pressures is a broader industry challenge, namely the laborious expansion of CAR-T into community care settings.
J&J’s bispecific antibodies Tecvayli and Talvey have posted some powerful clinical data in earlier-line multiple myeloma. These include MajesTEC-3, which recently got the combination of Tecvayli and J&J’s Darzalex approved by the FDA; MajesTEC-9 for Tecvayli monotherapy in a CD38-experienced population; and most recently, striking efficacy from the duo T-cell engager combo of Tecvayli and Talvey from the MonumenTAL-6 trial.
While investors worry these advances could shift J&J’s commercial priorities, Bash maintained that the two companies’ alliance remains robust.
“The bispecifics do provide an excellent option for patients, but Legend and J&J are both very committed to the opportunity with Carvykti,” Bash said, pointing to J&J’s stated $5 billion peak sales target for the BCMA-directed CAR-T.
Bash argued that market growth for CAR-T and TCEs is not a zero-sum game. With well over 100,000 relapsed or refractory myeloma patients in the U.S. and other major markets and fewer than 10% having utilized a BCMA therapy, “there is significant room for other options as well as Carvykti to grow,” Bash noted.
Furthermore, Carvykti’s unique profile as a one-time infusion with durable remissions and extended treatment-free intervals—or the potential for cure—is attractive to many patients, Bash said. And when patients have access to both CAR-T and TCE, doctors may prefer reaching for a CAR-T first, he noted.
Treatment sequencing is central to the current clinical conversation in myeloma, Bash explained to Fierce. Real-world evidence increasingly shows that CAR-T-first strategy yields an optimal efficacy and safety profile when used earlier in the treatment paradigm.
In a retrospective study using data from the TriNetX US Collaborative Network between 2021 and 2023, researchers linked BCMA-targeted CAR-T therapy to significantly improved two-year overall survival compared to Tecvayli, even though the latter was associated with lower risks of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (ICANS).
During a panel discussion at ASCO 2026, Saurabh Chhabra, M.D., a hematologist-oncologist from Mayo Clinic, said his preference is to use CAR-T first before bispecifics.
“That’s mainly because with the constant pressure from the bispecific antibody, we worry about development of the BCMA gene mutations […] which can impair the activity of the T cells when we collect them for CAR-T,” he said, adding that more data are needed to answer whether finite duration of TCE treatment could solve that problem.
As for upcoming competition from Gilead’s anito-cel, Legend has argued that the newcomer will not pose an immediate threat because it is slated for a later-line indication. Compared with its original fifth-line nod, about 70% of Carvykti uses in the U.S. today are for second- to fourth-line patients, Bash noted on Tuesday’s call.
When the two therapies eventually collide in earlier lines, Bash is counting on the experience Carvykti has built among doctors, as well as what he called a “best-in-class” manufacturing network, to retain market leadership.
After years of heavy investments, Legend and J&J have built enough production capacity to fully meet global demand near the end of 2025. Today, the partners have reduced Carvykti’s product turnaround time to within four weeks, a window that Bash said is “fully meeting” a patient’s clinical need given the bridging therapy they receive between cell collection and final product infusion. The Legend exec also touted a 99% manufacturing success rate and a 97% reliability rate in terms of delivering the product on the date it commits to.
“I think we’ve really taken manufacturing out of the equation for the patient experience, and we are continuing to expand that capacity, reduce the turnaround time and deliver to patients,” he said.
External competition aside, Legend and J&J face the systemic challenge of bringing Carvykti closer to patients on the community level, as setting up appropriate infrastructure at new treatment centers takes time. Currently, up to 40% of Carvykti’s treatment network consists of regional and community hospitals, Bash noted.
To promote penetration, the companies are pushing for Carvykti administration in the outpatient setting, made feasible by its delayed onset of cytokine release syndrome (CRS). Patients may later require inpatient admission to manage the immune side effect, but infusion in outpatient offices frees up bed capacity for treatment centers.
Last year, the FDA removed the Risk Evaluation and Mitigation Strategies requirements for existing CAR-T therapies, allowing patients to be monitored closer to home and get back to their lives more quickly.
To tackle the bottleneck around apheresis, meanwhile, Legend and J&J are currently trying to identify third parties who can provide this service to centers.
Ultimately, the two companies are not navigating the logistical challenge alone; the whole cell therapy field is striving to establish meaningful CAR-T infrastructure across community oncology settings.