Ankündigung • Sep 10

Legend Biotech Presents Updated Long-Term And Real-World Evidence From CARVYKTI Clinical Program At International Myeloma Society Annual Meeting

Legend Biotech Corporation announced that data from CARTITUDE-2 and real-world evidence will be presented at the 23rd International Myeloma Society Annual Meeting, taking place September 23-26, 2026, in Glasgow, Scotland. The presentations will include updated long-term follow-up data from the CARTITUDE-2 clinical trial evaluating the safety and efficacy of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) across different multiple myeloma disease settings. Long-term follow-up data will be presented from CARTITUDE-2 Cohort A in patients with lenalidomide-refractory multiple myeloma after 1-3 prior lines of therapy. Real-world evidence and post-authorization safety study findings will also be presented. CARTITUDE-2 (NCT04133636) is a Phase 2, multicohort study evaluating CARVYKTI across different multiple myeloma disease settings. Cohort A included patients with 1 to 3 prior lines of therapy who were exposed to a proteasome inhibitor and refractory to lenalidomide. Additional presentations will include real-world evidence and findings from a post-authorization safety study in patients with relapsed or refractory multiple myeloma. Together, the presentations at IMS and recently presented findings from the CARTITUDE-4 study contribute to the growing body of evidence evaluating CARVYKTI across multiple treatment settings and patient populations. Additional findings from the CARTITUDE clinical program were recently presented at the 14th Annual Meeting of the Society of Hematologic Oncology. IMS Poster Presentations: Abstract Number PA-288: Long-Term (=5-Year) Remission and Survival With Ciltacabtagene Autoleucel (Cilta-cel) in Relapsed/Refractory Multiple Myeloma (RRMM) With 1-3 Prior Lines of Therapy: CARTITUDE-2 Cohort A. Abstract Number PA-174: eMMpower-CART: Real-World Insights into Early-Line Cilta-cel Outcomes in Multiple Myeloma (MM). Abstract Number PA-199: First Results of a Noninterventional, Prospective, Postauthorization Safety Study (PASS) of Ciltacabtagene Autoleucel (Cilta-cel) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM). CARVYKTI® IMPORTANT SAFETY INFORMATION: WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED and RECURRENT CYTOPENIA, and SECONDARY HEMATOLOGICAL MALIGNANCIES. Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI®. Do not administer CARVYKTI® to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with CARVYKTI®. Provide supportive care and/or corticosteroids as needed. Parkinsonism and Guillain-Barré syndrome (GBS) and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI®. Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI®. HLH/MAS can occur with CRS or neurologic toxicities. Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with CARVYKTI®. Immune Effector Cell-associated Enterocolitis (IEC-EC), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI®. Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred in patients following treatment with CARVYKTI®. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI®. INCREASED EARLY MORTALITY - In CARTITUDE-4, a (1:1) randomized controlled trial, there was a numerically higher percentage of early deaths in patients randomized to the CARVYKTI® treatment arm compared to the control arm. Among patients with deaths occurring within the first 10 months from randomization, a greater proportion (29/208; 14%) occurred in the CARVYKTI® arm compared to (25/211; 12%) in the control arm. Of the 29 deaths that occurred in the CARVYKTI® arm within the first 10 months of randomization, 10 deaths occurred prior to CARVYKTI® infusion, and 19 deaths occurred after CARVYKTI® infusion. Of the 10 deaths that occurred prior to CARVYKTI® infusion, all occurred due to disease progression, and none occurred due to adverse events. Of the 19 deaths that occurred after CARVYKTI® infusion, 3 occurred due to disease progression, and 16 occurred due to adverse events. The most common adverse events were due to infection (n=12). CYTOKINE RELEASE SYNDROME (CRS), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® for RRMM in the CARTITUDE-1 & -4 studies (N=285), CRS occurred in 84% (238/285), including = Grade 3 CRS (ASTCT 2019) in 4% (11/285) of patients. Median time to onset of CRS, any grade, was 7 days (range: 1 to 23 days). CRS resolved in 82% with a median duration of 4 days (range: 1 to 97 days). The most common manifestations of CRS in all patients combined (=10%) included fever (84%), hypotension (29%) and aspartate aminotransferase increased (11%). Serious events that may be associated with CRS include pyrexia, hemophagocytic lymphohistiocytosis, respiratory failure, disseminated intravascular coagulation, capillary leak syndrome, and supraventricular and ventricular tachycardia. CRS occurred in 78% of patients in CARTITUDE-4 (3% Grade 3 to 4) and in 95% of patients in CARTITUDE-1 (4% Grade 3 to 4). Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS. Confirm that a minimum of 2 doses of tocilizumab are available prior to infusion of CARVYKTI®. Of the 285 patients who received CARVYKTI® in clinical trials, 53% (150/285) patients received tocilizumab; 35% (100/285) received a single dose, while 18% (50/285) received more than 1 dose of tocilizumab. Overall, 14% (39/285) of patients received at least 1 dose of corticosteroids for treatment of CRS. Monitor patients at least daily for 7 days following CARVYKTI® infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 2 weeks after infusion.

Ankündigung • May 24

Legend Biotech Corporation to Highlight Leadership in CAR-T Cell Therapy for Patients with Multiple Myeloma at ASCO and EHA

Legend Biotech Corporation announced that new and updated data from the CARTITUDE clinical development program evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for patients with multiple myeloma will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2024 European Hematology Association’s (EHA) Hybrid Congress. Data from Cohort D of the Phase 2 CARTITUDE-2 study investigating a single infusion of CARVYKTI® with or without lenalidomide maintenance in patients who achieved less than complete response after autologous stem cell transplant (ASCT) frontline therapy will be presented for the first time in an oral presentation at ASCO and in an encore oral presentation at EHA. Data from the subgroup analysis of the Phase 3 CARTITUDE-4 study of CARVYKTI® versus two standard therapies in patients with functional high-risk multiple myeloma after one prior line of treatment will be presented in an oral presentation at ASCO. Additionally, the results of the CARTITUDE-4 subgroup analysis by cytogenetic risk will be shared at EHA in a poster session. INCREASED EARLY MORTALITY - In CARTITUDE-4, a (1:1) randomized controlled trial, there was a numerically higher percentage of early deaths in patients randomized to the CARVYKTI® treatment arm compared to the control arm. Among patients with deaths occurring within the first 10 months from randomization, a greater proportion (29/208; 14%) occurred in the CARVYKTI® arm compared to (25/211; 12%) in the control arm. Of the 29 deaths that occurred in the CARVYKTI® arm within the first 10 months of randomization, 10 deaths occurred prior to CARVYKTI® infusion, and 19 deaths occurred after CARVYKTI® infusion. Of the 10 deaths that occurred prior to CARVYKTI® infusion, all occurred due to disease progression, and none occurred due to adverse events. Of the 19 deaths that occurred after CARVYKTI® infusion, 3 occurred due to disease progression, and 16 occurred due to adverse events. The most common adverse events were due to infection (n=12). CYTOKINE RELEASE SYNDROME (CRS),including fatal or life-threatening reactions, occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® for RRMM in the CARTITUDE-1 & 4 studies (N=285), CRS occurred in 84% (238/285), including = Grade 3 CRS (ASCT 2019) in 4% (11/285) of patients. Median time to onset of CRS, any grade, was 7 days (range: 1 to 23 days). CRS resolved in 82% with a median duration of 4 days (range: 1 to 97 days). The most common manifestations of CRS in all patients combined (= 10%) included fever (84%), hypotension (29%) and aspartate aminotransferase increased (11%). Serious events that may be associated with CRS include pyrexia, hemophagocytic lymphohistiocytosis, respiratory failure, disseminated intravascular coagulation, capillary leak syndrome, and supraventricular and ventricular tachycardia. CRS occurred in 78% of patients in CARTITUDE-4 (3% Grade 3 to 4) and in 95% of patients in CARTITUDE-1 (4% Grade 3 to 4). Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS. Please see Section 5.4; Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS) Ensure that a minimum of two doses of tocilizumab are available prior to infusion of CARVYKTI®. Of the 285 patients who received CARVYKTI® in clinical trials, 53% (150/285) patients received tocilizumab; 35% (100/285) received a single dose, while 18% (50/285) received more than 1 dose of tocilizumab. Overall, 14% (39/285) of patients received at least one dose of corticosteroids for treatment of CRS. Monitor patients at least daily for 10 days following CARVYKTI® infusion at a REMS-certified healthcare facility for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 4 weeks after infusion. At the first sign of CRS, immediately institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. NEUROLOGIC TOXICITIES, which may be severe, life-threatening, or fatal, occurred following treatment with CARVYKTI®. Neurologic toxicities included ICANS, neurologic toxicity with signs and symptoms of parkinsonism, GBS, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Counsel patients on the signs and symptoms of these neurologic toxicities, and on the delayed nature of onset of some of these toxicities. Instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies for RRMM, one or more neurologic toxicities occurred in 24% (69/285), including = Grade 3 cases in 7% (19/285) of patients. Median time to onset was 10 days (range: 1 to 101) with 63/69 (91%) of cases developing by 30 days. Neurologic toxicities resolved in 72% (50/69) of patients with a median duration to resolution of 23 days (range: 1 to 544). Of patients developing neurotoxicity, 96% (66/69) also developed CRS. Subtypes of neurologic toxicities included ICANS in 13%, peripheral neuropathy in 7%, cranial nerve palsy in 7%, parkinsonism in 3%, and immune mediated myelitis in 0.4% of the patients. Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Patients receiving CARVYKTI® may experience fatal or life-threatening ICANS following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, ICANS occurred in 13% (36/285), including Grade =3 in 2% (6/285) of the patients. Median time to onset of ICANS was 8 days (range: 1 to 28 days). ICANS resolved in 30 of 36 (83%) of patients with a median time to resolution of 3 days (range: 1 to 143 days). Median duration of ICANS was 6 days (range: 1 to 1229 days) in all patients including those with ongoing neurologic events at the time of death or data cut-off. Of patients with ICANS, 97% (35/36) had CRS. The onset of ICANS occurred during CRS in 69% of patients, before and after the onset of CRS in 14% of patients respectively. Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3) and in 23% of patients in CARTITUDE-1 (3% Grade 3). The most frequent =2% manifestations of ICANS included encephalopathy (12%), aphasia (4%), headache (3%), motor dysfunction (3%), ataxia (2%), and sleep disorder (2%) [see Adverse Reactions (6.1)].

Prozentsatz des Geschäftsführergehalts	n/a
Amtszeit als Geschäftsführer	less than a year
Eigentum des Geschäftsführers	0.004%
Durchschnittliche Amtszeit des Managements	less than a year
Durchschnittliche Amtszeit der Vorstandsmitglieder	4.1yrs

Name	Position	Amtszeit	Vergütung	Eigentümerschaft
Alan Bash	Interim CEO	less than a year	keine Daten	0.0044% $ 159.6k
Carlos Garcia	Chief Financial Officer	1.1yrs	keine Daten	keine Daten
Ananda Martin	Global Compliance Officer	less than a year	keine Daten	keine Daten
Robert Staloff	General Counsel	less than a year	keine Daten	keine Daten
Yuhong Qiu	Interim Head of Research & Development and Senior VP of Regulatory Affairs	less than a year	keine Daten	keine Daten
Birk Vanderweeen	Senior Vice President of Global Manufacturing & Supply	2.8yrs	keine Daten	keine Daten
Surabhi Verma	Manager of Investor Relations & Corporate Communications	no data	keine Daten	keine Daten
Joanne Choi	Senior Manager of Investor Relations	no data	keine Daten	keine Daten

Name	Position	Amtszeit	Vergütung	Eigentümerschaft
John Michael Maraganore	Member of Strategic Advisory Board	3.4yrs	keine Daten	keine Daten
Corazon Sanders	Independent Director	6.3yrs	keine Daten	0.010% $ 378.2k
Gareth Kung	Independent Director	less than a year	keine Daten	keine Daten
Xiaohui Ji	Independent Director	6.3yrs	keine Daten	0.010% $ 361.2k
Tomas Heyman	Independent Director	4.1yrs	keine Daten	0.0037% $ 132.2k
Fangliang Zhang	Independent Chairman	4.1yrs	keine Daten	keine Daten
Ye Wang	Director	11.3yrs	keine Daten	0% $ 0
Jiange Meng	Director	less than a year	keine Daten	keine Daten
Michel Vounatsos	Member of Strategic Advisory Board	3.4yrs	keine Daten	keine Daten
Patrick Casey	Independent Director	5.8yrs	keine Daten	0.0092% $ 333.4k
Li Mao	Independent Director	4.1yrs	keine Daten	0.0067% $ 240.6k
Peter Salovey	Lead Independent Director	2.1yrs	keine Daten	0.0014% $ 48.8k

Daten	Zuletzt aktualisiert (UTC-Zeit)
Unternehmensanalyse	2026/09/14 11:57
Aktienkurs zum Tagesende	2026/09/14 00:00
Gewinne	2026/06/30
Jährliche Einnahmen	2025/12/31

Paket	Daten	Zeitrahmen	Beispiel US-Quelle ^*
Finanzdaten des Unternehmens	10 Jahre	Gewinn- und Verlustrechnung Kapitalflussrechnung Bilanz	SEC-Formular 10-K SEC-Formular 10-Q
Konsensschätzungen der Analysten	+3 Jahre	Finanzielle Vorausschau Kursziele der Analysten	Analysten Research Berichte Blue Matrix
Marktpreise	30 Jahre	Aktienkurse Dividenden, Splits und Aktionen	ICE-Marktdaten SEC-Formular S-1
Eigentümerschaft	10 Jahre	Top-Aktionäre Insiderhandel	SEC-Formular 4 SEC-Formular 13D
Verwaltung	10 Jahre	Das Führungsteam Direktorium	SEC-Formular 10-K SEC-Formular DEF 14A
Wichtige Entwicklungen	10 Jahre	Ankündigungen des Unternehmens	SEC-Formular 8-K

Analyst	Einrichtung
"Etzer Darout	Barclays
Huidong Wang	Barclays
Etzer Darout	Barclays

Legend Biotech Management

Management Kriterienprüfungen 1/4

Wichtige Informationen

Jüngste Management Updates

Legend Biotech Corporation, Annual General Meeting, Sep 24, 2026

Legend Biotech Corporation Announces CEO Changes

Legend Biotech Corporation Announces That Ying Huang, Ph.D., Has Stepped Down as A Member of the Board of Directors, Effective as of July 24, 2026

Legend Biotech Corporation Announces Board and Audit Committee Changes, Effective February 2, 2026

Legend Biotech Corporation Announces Changes to Board of Directors and Audit Committee, Effective January 20, 2026

CEO & Director notifies of intention to sell stock

Recent updates

Legend Biotech Presents Updated Long-Term And Real-World Evidence From CARVYKTI Clinical Program At International Myeloma Society Annual Meeting

LEGN: In Vivo CAR T Progress And CEO Resolution Will Shape Upside Potential

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Legend Biotech Corporation, Annual General Meeting, Sep 24, 2026

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Legend's Pipeline Is Starting To Matter

Second quarter 2026 earnings: Revenues exceed analysts expectations while EPS lags behind

LEGN: In Vivo Lymphoma Program Will Drive Future Upside Potential

Legend Biotech Corporation to Report Q2, 2026 Results on Aug 11, 2026

Legend Biotech Corporation Announces CEO Changes

Legend Biotech Appoints Interim CEO After Sudden Leadership Change at Top

Legend Biotech Corporation Announces That Ying Huang, Ph.D., Has Stepped Down as A Member of the Board of Directors, Effective as of July 24, 2026

LEGN: Future Returns Expected From Expanding Multiple Myeloma Franchise Execution

LEGN: In Vivo CAR T Progress And Equity Raise Will Test Expectations

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Legend Biotech Corporation has completed a Follow-on Equity Offering in the amount of $225.995 million.

Legend Biotech (LEGN) Stock Could Be 51.2% Undervalued After Equity Raise And LB2501 Data

Legend Biotech Corporation has filed a Follow-on Equity Offering in the amount of $225 million.

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LEGN: Future CARTITUDE And In Vivo Data Will Test Lofty Expectations

Legend Biotech’s LB2501 Achieves 100% Response in Early B-Cell Lymphoma Trial

New minor risk - Share price stability

Legend Biotech Corporation Announces Late-Breaking Oral Presentation of Initial Phase 1 in Vivo Car-T Data with Lb2501 in Non-Hodgkin Lymphoma

LEGN: Future Trial Data And Capacity Expansion Will Shape Risk And Opportunity

First quarter 2026 earnings: EPS misses analyst expectations

LEGN: CARTITUDE 5 And In Vivo Pipeline Will Drive Future Upside Potential

LEGN: Future Returns Expected From Execution On Multiple Myeloma Opportunity

LEGN: Future Returns Expected From Multiple Myeloma Franchise Execution

LEGN: Future FDA Guidance And Trial Readouts Will Support Long-Term Upside

Full year 2025 earnings: EPS misses analyst expectations

LEGN: Future Profitability Expected From Lead Cell Therapy Platform Despite Recent Downgrades

Price target decreased by 8.4% to US$58.70

LEGN: FDA Guidance And Cell Therapy Data Will Support Long-Term Upside

Legend Biotech Corporation Announces Board and Audit Committee Changes, Effective February 2, 2026

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LEGN: Future Profitability Expected From Flagship Therapy Despite Recent Rating Caution

Legend Biotech Corporation Announces Changes to Board of Directors and Audit Committee, Effective January 20, 2026

LEGN: CAR T Franchise And Supportive FDA Guidance Will Shape Upside Potential

Price target decreased by 7.1% to US$66.72

LEGN: Future Profitability From Flagship Therapy Expected To Drive Share Upside

CEO & Director notifies of intention to sell stock

LEGN: Future Margin Improvement Will Drive Upside From Current Levels

Investors Don't See Light At End Of Legend Biotech Corporation's (NASDAQ:LEGN) Tunnel And Push Stock Down 26%

LEGN: Late Stage Pipeline Execution Will Drive Future Market Expansion

LEGN: Global Listing Pursuits Will Drive Future Market Expansion

Third quarter 2025 earnings: EPS and revenues miss analyst expectations

LEGN: Rising Global Demand Will Drive Franchise Expansion Beyond the U S

Market Momentum and Global Listing Plans Will Drive Significant Upside Potential

Next Generation Cell Therapy Will Expand Global Patient Access

Legend Biotech Corporation Announces U.S. Fda Approves Label Updates for Carvykti® Car-T Cell Therapy to Include Overall Survival Data

Next Generation Cell Therapy Will Expand Global Patient Access

Legend Biotech Corporation Announces Chief Financial Officer Changes

Second quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind

Here's Why Legend Biotech (NASDAQ:LEGN) Can Manage Its Debt Despite Losing Money

Legend Biotech Corporation to Report Q2, 2025 Results on Aug 11, 2025

CEO & Director notifies of intention to sell stock

CEO & Director notifies of intention to sell stock

There's Reason For Concern Over Legend Biotech Corporation's (NASDAQ:LEGN) Massive 32% Price Jump

Legend Biotech Corporation Appoints Peter Salovey as Lead Independent Director, Effective June 5, 2025

Legend Biotech Corporation Unveils 5-Year Survival Data for Carvykti®? in Multiple Myeloma At 2025 Asco Annual Meeting

Legend Biotech Corporation to Present New Data on Carvykti for Patients with Multiple Myeloma At 2025 Asco and Eha Annual Meeting

First quarter 2025 earnings: EPS misses analyst expectations

Expanding Facilities In Belgium And New Jersey Will Boost Reach

Full year 2024 earnings: EPS and revenues exceed analyst expectations

Legend Biotech's Carvykti Is Taking Off, And It's Still Early (Rating Upgrade)

Consensus EPS estimates upgraded to US$1.32 loss

Top 5 Commercial Biotech Buyout Candidates: Legend Biotech (No. 4)