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Legend Biotech reports CARVYKTI sales of about $710M in Q3 and FDA IND clearance for in vivo CAR-T

Legend Biotech Corp (LEGN) · Tue 10 Nov 2026

Legend Biotech posted third-quarter CARVYKTI net trade sales of about $710 million and operating income of $46.8 million, and said the FDA cleared its IND for CD19/CD20 in vivo CAR-T LB2501.

Legend Biotech Corp reported its third-quarter 2026 results on 10 November. CARVYKTI (cilta-cel) generated net trade sales of about $710 million, and the company recorded operating income of $46.8 million. The headline title describes the sales as up 36%. The summary does not state the comparison period.

On the pipeline side, Legend said the US Food and Drug Administration has cleared an investigational new drug (IND) application for LB2501, a CD19/CD20 in vivo CAR-T therapy for B-cell malignancies. As context, an IND clearance allows a sponsor to begin clinical testing in humans in the US. It is not a marketing authorisation and says nothing about efficacy or safety.

The company also reported five-year data from Cohort A of the CARTITUDE-2 study in earlier-line relapsed/refractory multiple myeloma. The summary gives no detailed efficacy or safety figures from the analysis. Legend further noted that updated NCCN guidance now favours referral for CAR-T therapy at first relapse.

On corporate matters, Ingrid Zhang became chief executive officer effective 15 September. Legend ended the quarter with cash and time deposits of about $853 million.

What it means for your team

  • Market-access teams should note the updated NCCN guidance favouring CAR-T referral at first relapse, which may inform earlier-line positioning and payer discussions in myeloma.
  • Regulatory teams should track LB2501: the FDA IND clearance opens clinical testing of a CD19/CD20 in vivo CAR-T approach, but no clinical data are yet reported.
  • Pharmacovigilance and clinical teams may want to review the full CARTITUDE-2 five-year dataset when published, since the summary does not give safety details.

Company's press release (SEC filing): Legend Biotech Corp ↗

Article written by VigiEye from the official source (Legend Biotech Corp). Claims are the company's own. AI-assisted; check the source before acting.

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