Legend Biotech Corporation

Legend Biotech Announces U.S. FDA Clearance of IND Application for LB2501, an Investigational CD19/CD20 In Vivo CAR-T Therapy

The FDA cleared Legend Biotech's IND application for LB2501, an investigational in vivo CAR-T therapy targeting CD19/CD20 for relapsed or refractory B-cell malignancies including B-cell non-Hodgkin lymphoma. LB2501 is an off-the-shelf, single-infusion therapy designed to generate CAR-T cells directly within the patient, and is the first known dual-targeting in vivo CAR-T to receive IND clearance; a planned U.S. Phase 1/2 study will assess safety, tolerability, pharmacokinetics, and preliminary efficacy, and a Phase 1 study is ongoing in China (NCT07002112). The clearance advances Legend's in vivo cell engineering strategy on its proprietary TaVec platform, complementing its commercial CARVYKTI franchise with Johnson & Johnson.

•17d ago

Legend Biotech Presents CARVYKTI Data Showing Half of Patients with RRMM Remained Progression-Free and Alive Five Years After a Single Infusion

Legend Biotech presented five-year follow-up data from CARTITUDE-2 Cohort A (n=20) at the 2026 International Myeloma Society meeting, showing 50% of earlier-line RRMM patients alive and progression-free five years after a single CARVYKTI infusion. Median progression-free survival reached 60.5 months, five-year overall survival was 69.2%, and median overall survival was not reached; safety remained consistent with the known profile with no new CAR T-cell-related neurotoxicity. One patient developed acute myeloid leukemia and two deaths from progressive disease or new cancer occurred since the ~30-month analysis, and the small single-arm cohort limits how strongly the durability data can be extrapolated.

•1mo ago

Legend Biotech Appoints Ingrid Zhang as Chief Executive Officer

Legend Biotech's board appointed Ingrid Zhang as Chief Executive Officer effective September 15, 2026, ending an interim leadership period that began in July 2026. Zhang succeeds Alan Bash, who returns to his role as President, CARVYKTI; she was most recently Chief Commercial Officer for Novartis International, where she also led Novartis's China business and innovative medicines organization, with earlier roles at AstraZeneca, Pfizer, and McKinsey. The hire leans heavily commercial as Legend scales CARVYKTI, its one-time CAR-T therapy for relapsed or refractory multiple myeloma marketed with collaborator Johnson & Johnson across a base of over 3,000 employees.

•1mo ago

Legend Biotech Reports Second Quarter 2026 Results and Recent Highlights

Legend Biotech swung to profitability in Q2 2026 with net income of $33.2 million, compared to a net loss of $125.4 million in the prior year, driven by a 50% year-over-year increase in CARVYKTI sales to approximately $657 million. The company reported positive clinical proof-of-concept for LB2501, showing a 100% overall response rate, and strengthened its balance sheet with $965 million in cash following a $212 million public offering. Alan Bash was appointed Interim CEO, and management confirmed that the current financial runway extends beyond 2026, supporting expectations for achieving company-wide profitability.

•2mo ago

Calidi Biotherapeutics Appoints Former Genentech/Roche and Celgene Executive Corsee Sanders, Ph.D., to Board of Directors

Calidi Biotherapeutics appointed Corsee Sanders, Ph.D., a biopharma industry veteran with 23 years of experience at Genentech/Roche, as an independent director to its board. Dr. Sanders previously served as an executive at Juno and advised Celgene and Bristol Myers Squibb following acquisitions, bringing significant clinical development and integration expertise. She currently serves on the boards of Legend Biotech and Ultragenyx, and will support Calidi as it advances its CLD-401 candidate and RedTail platform.

•4mo ago

Legend Biotech Establishes Clinical Proof-of-Concept for LB2501, a Potential First-in-Class In Vivo CD19/CD20 Dual-Targeting CAR-T, in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

Legend Biotech announced first clinical proof-of-concept data for LB2501, a potential first-in-class in vivo CD19/CD20 dual-targeting CAR-T therapy, in relapsed/refractory B-cell non-Hodgkin lymphoma. At the higher dose level (DL2), LB2501 achieved a 100% objective response rate and an 83.3% complete response rate following a single infusion without lymphodepletion. The safety profile was favorable with no dose-limiting toxicities, serious adverse events, or ICANS reported; all cytokine release syndrome events were Grade 1-2 and did not require glucocorticoids.

•4mo ago

Legend Biotech Establishes Clinical Proof-of-Concept for LB2501, a Potential First-in-Class In Vivo CD19/CD20 Dual-Targeting CAR-T, in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

Legend Biotech reported strong Phase 1 proof-of-concept data for LB2501, an investigational in vivo CD19/CD20 dual-targeting CAR-T therapy for relapsed/refractory B-cell non-Hodgkin lymphoma. At the higher dose level (DL2), the therapy achieved a 100% objective response rate and an 83.3% complete response rate in six patients, with all responses ongoing at data cutoff. The study demonstrated dose-dependent in vivo CAR-T expansion without the need for lymphodepletion, and reported no dose-limiting toxicities, serious adverse events, or ICANS. Results were presented in a late-breaking session at EHA 2026.

•4mo ago

Legend Biotech Announces Late-Breaking Oral Presentation at EHA 2026 Showcasing Initial Phase 1 In Vivo CAR-T Data with LB2501 in Non-Hodgkin Lymphoma (NHL)

Legend Biotech will present late-breaking Phase 1 data for LB2501, an in vivo CAR-T therapy, at the EHA 2026 Congress in Stockholm. The data shows a 100% objective response rate and 83.3% complete response rate in the dose level 2 cohort of patients with relapsed/refractory B-cell non-Hodgkin lymphoma. The safety profile was favorable, with no dose-limiting toxicities, serious adverse events, or ICANS reported, and all cytokine release syndrome events were Grade 2 or lower.

•4mo ago

Legend Biotech Presents First-in-Human LB2102 Results in Solid Tumors and New CARVYKTI® Data in Multiple Myeloma at ASCO 2026

Legend Biotech presented first-in-human Phase 1 data for LB2102, a DLL3-targeted CAR-T therapy for solid tumors, at ASCO 2026. At higher dose levels, LB2102 achieved an objective response rate of 28.6% and a disease control rate of 78.6% in heavily pretreated patients with small cell lung cancer or large-cell neuroendocrine carcinoma. The company also shared new analyses for its approved therapy CARVYKTI, showing >85% 30-month overall survival rates in multiple myeloma patients and a low 1.2% incidence of immune effector cell-associated enterocolitis.

•5mo ago

Legend Biotech Announces Presentations at ASCO 2026

Legend Biotech will present preliminary Phase 1 data for LB2102, its DLL3-targeted CAR-T therapy for solid tumors, in a rapid oral presentation at ASCO 2026. The data highlights early evidence of clinical activity in small-cell lung cancer and large-cell neuroendocrine carcinoma, alongside a manageable safety profile. The company will also present poster data on CARVYKTI, including a cytogenetic subgroup analysis from the CARTITUDE-4 trial and a multi-study analysis of immune effector cell-associated enterocolitis.

•5mo ago

Legend Biotech Expands Scientific Advisory Expertise to Inform Future Growth

Legend Biotech formed a scientific advisory board featuring six prominent experts in cell therapy, including CAR-T pioneer Carl June. The advisors will provide strategic guidance on R&D priorities and help identify new areas of unmet need as the company expands its pipeline beyond current products. Legend Biotech currently markets CARVYKTI with collaborator Johnson & Johnson and employs over 3,000 people.

•5mo ago