Legend's Carvykti revenue reaches about $710M in quarter; FDA clears in vivo CAR-T trial
The cell therapy maker booked an operating profit in the third quarter and won US clearance to test a CD19/CD20 in vivo CAR-T, under a newly installed chief executive.
Legend Biotech's lead product, the BCMA-directed CAR-T Carvykti (cilta-cel), brought in roughly $710 million in the third quarter of 2026, the company said on 10 November. Legend reported operating income of $46.8 million for the period. A 36% growth rate has been attached to the sales figure, but the information available does not say which period it is measured against, so we have not treated it as confirmed.
The company also said the US Food and Drug Administration has cleared an investigational new drug application for LB2501, a CD19/CD20 in vivo CAR-T candidate for B-cell malignancies. By way of context, an IND clearance only permits a sponsor to start human trials in the US. It is not an approval and says nothing about whether the product works or is safe. No clinical data for LB2501 have been disclosed.
On the commercial side, Legend pointed to two supports for Carvykti's positioning in myeloma. It reported five-year follow-up from Cohort A of CARTITUDE-2, which studies earlier-line relapsed or refractory disease, though no efficacy or safety figures from that analysis were available to us. It also noted that updated NCCN guidance now favours referring patients for CAR-T at first relapse.
Ingrid Zhang took over as chief executive on 15 September. Legend closed the quarter with about $853 million in cash and time deposits.
Why it matters
- A quarterly operating profit alongside roughly $710M of Carvykti sales shows the product is carrying the company's finances, though the growth comparison period remains unstated.
- The NCCN shift towards CAR-T referral at first relapse may feed into earlier-line positioning and payer discussions in myeloma.
- LB2501 is at the start of its path: the IND clearance permits human testing, but no clinical results exist yet.
- The full CARTITUDE-2 five-year dataset will be needed to judge long-term safety and durability, as the details were not provided.
Company's press release (SEC filing): Legend Biotech Corp ↗
Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.