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)].

Ankündigung • Apr 23

Legend Biotech Corporation's CARVYKTI® (ciltacabtagene autoleucel) Approved by the European Commission for Second-line Treatment of Patients with Relapsed and Refractory Multiple Myeloma

Legend Biotech Corporation announced that the European Commission (EC) has granted approval of CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), have demonstrated disease progression on the last therapy and are refractory to lenalidomide. The European approval is based on positive results from the CARTITUDE-4 study, which demonstrated that CARVYKTI® resulted in statistically significant and clinically meaningful improvement of progression-free survival compared to two standard of care treatment regimens, pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd), in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy. The Type-II variation application was submitted to the European Medicines Agency (EMA) by Janssen-Cilag International N.V., an affiliate of Janssen Biotech Inc., a Johnson & Johnson company, Legend Biotech’s collaborator for the development and commercialization of CARVYKTI®. The EC approval follows the U.S. Food and Drug Administration (FDA) approval of CARVYKTI® on April 5th for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a PI and an IMiD and are refractory to lenalidomide.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)]. Monitor patients at least daily for 10 days following CARVYKTI® infusion at the REMS-certified healthcare facility for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms. Monitor patients for signs or symptoms of ICANS for at least 4 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed [see Dosage and Administration (2.3)].

Schneeflocken-Punktzahl
Bewertung	5/6
Künftiges Wachstum	4/6
Vergangene Leistung	0/6
Finanzielle Gesundheit	4/6
Dividenden	0/6

Historische Aktienkurse
Aktueller Aktienkurs	US$21.82
52-Wochen-Hoch	US$37.50
52-Wochen-Tief	US$16.24
Beta	0.39
1 Monat Veränderung	-1.80%
3 Monate Veränderung	-26.11%
1 Jahr Veränderung	-36.94%
3 Jahre Veränderung	-68.42%
5 Jahre Veränderung	-42.46%
Veränderung seit IPO	-41.03%

	LEGN	US Biotechs	US Markt
7D	5.7%	6.3%	-1.2%
1Y	-36.9%	47.2%	18.3%

LEGN volatility
LEGN Average Weekly Movement	15.7%
Biotechs Industry Average Movement	9.9%
Market Average Movement	7.2%
10% most volatile stocks in US Market	16.4%
10% least volatile stocks in US Market	3.1%

LEGN grundlegende Statistiken
Marktanteil	US$4.23b
Gewinn(TTM)	-US$91.50m
Umsatz(TTM)	US$1.27b

LEGN Gewinn- und Verlustrechnung (TTM)
Einnahmen	US$1.27b
Kosten der Einnahmen	US$552.10m
Bruttogewinn	US$719.30m
Sonstige Ausgaben	US$810.80m
Gewinn	-US$91.50m

Gewinn per Aktie (EPS)	-0.47
Bruttomarge	56.58%
Nettogewinnspanne	-7.20%
Schulden/Eigenkapital-Verhältnis	12.7%

Daten	Zuletzt aktualisiert (UTC-Zeit)
Unternehmensanalyse	2026/08/24 11:43
Aktienkurs zum Tagesende	2026/08/21 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
Rick Bienkowski	Cantor Fitzgerald & Co.

Legend Biotech (LEGN) Aktienübersicht

Belohnungen

Risikoanalyse

Analyst Price Targets

CAR-T Advancements Will Expand Global Cancer Therapy Access

Market Momentum and Global Listing Plans Will Drive Significant Upside Potential

Price Controls And Competitive Risks Will Challenge Cell Therapy Recovery

Top Analyst Narratives

CAR-T Advancements Will Expand Global Cancer Therapy Access

Market Momentum and Global Listing Plans Will Drive Significant Upside Potential

Price Controls And Competitive Risks Will Challenge Cell Therapy Recovery

Legend Biotech Corporation Wettbewerber

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Arcutis Biotherapeutics

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Mirum Pharmaceuticals

Preisentwicklung & Leistung

Aktuelle Nachrichten und Updates

LEGN: Future Returns Will Depend On Expanding Cell Therapy Franchise Execution

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

Legend Biotech Hits First Profitability and Unveils Positive In Vivo CAR-T Data in Q2

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

Recent updates

LEGN: Future Returns Will Depend On Expanding Cell Therapy Franchise Execution

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

Legend Biotech Hits First Profitability and Unveils Positive In Vivo CAR-T Data in Q2

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

Legend Biotech Unveils 100% Response With LB2501 CAR-T for B-Cell Lymphoma in Phase 1

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.

Legend Biotech Establishes Clinical Proof-of-Concept for LB2501 in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

Legend Biotech Reports Promising Phase 1 Results for Dual-Targeting CAR-T Therapy in Lymphoma

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

Why Investors Shouldn't Be Surprised By Legend Biotech Corporation's (NASDAQ:LEGN) 26% Share Price Plunge

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