Legend Biotech announced that the U.S. FDA has cleared the investigational new drug (IND) application for LB2501, an innovative in vivo CAR-T therapy targeting CD19 and CD20 to treat relapsed or refractory B-cell malignancies, including non-Hodgkin lymphoma. This off-the-shelf, single-infusion therapy generates CAR-T cells directly within patients, potentially simplifying treatment by avoiding complex manufacturing steps and lymphodepleting chemotherapy. The FDA clearance enables a planned Phase 1/2 clinical trial in the U.S. to evaluate LB2501's safety, tolerability, and preliminary efficacy. This milestone advances Legend Biotech's in vivo cell engineering platform and could improve access to transformative cancer therapies.
Legend Biotech's FDA clearance for LB2501 provides context for health sector activity. For readers following health stocks, 93 of 150 US health-sector stocks on Pluang rose while 49 fell. Notable movers include CTXR at USD 0.45 with a -3.01% change and 100% buy order activity, RXRX at USD 3.63 down -2.94% with 73% sell orders, and ACB at USD 4.05 down -2.88%. This data is as of Oct 15, 2026 18:13 WIB.
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