Legend Biotech to Present CARVYKTI® Data at 2026 Tandem Meetings Reinforcing Growing Evidence Supporting Earlier Use

Rhea-AI Summary

Legend Biotech (NASDAQ: LEGN) will present six posters on CARVYKTI® (ciltacabtagene autoleucel) at the Tandem Meetings, Feb 4-7, 2026, summarizing clinical and real-world evidence across CARTITUDE trials. Presentations highlight consistent, durable efficacy and safety signals and note clinically meaningful quality-adjusted survival gains, especially when CARVYKTI is used earlier in the multiple myeloma treatment continuum. CARVYKTI is the first and only BCMA-targeted CAR-T approved for patients with at least one prior therapy and is commercially available in 14 countries. The release also details important safety information, including CRS, neurologic toxicities, and warnings from CARTITUDE-1 and -4.

Positive

• First and only BCMA-targeted CAR-T approved for patients with ≥1 prior therapy
• Commercial availability of CARVYKTI in 14 countries
• Presentations report clinically meaningful quality-adjusted survival gains when used earlier

Negative

• Numerically higher early deaths in CARTITUDE-4: 29/208 (14%) vs 25/211 (12%)
• High cytokine release syndrome incidence: 84% (238/285) overall; Grade ≥3 in 4% (11/285)
• Neurologic toxicities in CARTITUDE-1 & 4: 24% (69/285); Grade ≥3 in 7% (19/285)

News Market Reaction

-11.36% 2.2x vol

53 alerts

-11.36% News Effect

-14.2% Trough in 32 hr 45 min

-$554M Valuation Impact

$4.33B Market Cap

2.2x Rel. Volume

On the day this news was published, LEGN declined 11.36%, reflecting a significant negative market reaction. Argus tracked a trough of -14.2% from its starting point during tracking. Our momentum scanner triggered 53 alerts that day, indicating high trading interest and price volatility. This price movement removed approximately $554M from the company's valuation, bringing the market cap to $4.33B at that time. Trading volume was elevated at 2.2x the daily average, suggesting increased selling activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Patients treated: More than 10,000 patients Countries commercialized: 14 countries Poster presentations: 6 posters +5 more

8 metrics

Patients treated More than 10,000 patients Global CARVYKTI® treatment experience cited in article

Countries commercialized 14 countries Global commercial availability of CARVYKTI®

Poster presentations 6 posters CARVYKTI® data at 2026 Tandem Meetings

CRS incidence 84% (238/285 patients) CARTITUDE-1 & -4 CARVYKTI® treated population

Severe CRS 4% (11/285 patients) Grade ≥3 CRS in CARTITUDE-1 & -4

ICANS incidence 13% (36/285 patients) CARTITUDE-1 & -4 CARVYKTI® treated population

Parkinsonism incidence 3% (8/285 patients) CARTITUDE-1 & -4 CARVYKTI® treated population

HLH/MAS incidence 1% (3/285 patients) CARTITUDE-1 & -4 CARVYKTI® treated population

Market Reality Check

Price: $18.27 Vol: Volume 4,841,747 is 2.14x...

high vol

$18.27 Last Close

Volume Volume 4,841,747 is 2.14x the 20-day average of 2,267,085, indicating elevated interest ahead of the data presentations. high

Technical Shares trade below the 200-day MA, with price at $23.42 versus 200-day MA of $32.05, and about 48.3% below the 52-week high.

Peers on Argus

LEGN’s move contrasted with mixed biotech peers: AXSM up 3.65%, CYTK up 3.05%, R...

LEGN’s move contrasted with mixed biotech peers: AXSM up 3.65%, CYTK up 3.05%, RYTM up 0.97%, while ABVX fell 0.87% and MRUS fell 7.08%, suggesting a company-specific reaction to CARVYKTI data.

Historical Context

5 past events · Latest: Jan 12 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 12	Business update	Positive	+0.4%	Outlined 2026 priorities and CARVYKTI franchise scale and profitability goals.
Dec 17	Conference appearance	Positive	-1.1%	Announced CEO presentation at J.P. Morgan Healthcare Conference and webcast details.
Nov 13	Facility opening	Positive	-0.5%	Opened new 31,000-square-foot Philadelphia cell therapy R&D facility expanding U.S. footprint.
Nov 12	Earnings update	Positive	-2.7%	Reported Q3 2025 results with strong CARVYKTI sales and ~${1.0}B cash/time deposits.
Nov 03	Conference data slate	Positive	-0.8%	Announced 10 ASH presentations, including multiple CARVYKTI and Lucar-G39D data readouts.

Pattern Detected

Recent positive corporate and clinical updates have often met with flat or negative next-day moves, suggesting muted or skeptical reactions to news.

Recent Company History

Over the last few months, Legend Biotech has focused updates on CARVYKTI growth, profitability, and expanded data visibility. On Nov 3, 2025, it announced 10 ASH 2025 presentations, including new CARVYKTI and Lucar-G39D data. The Nov 12, 2025 Q3 results highlighted $524M CARVYKTI net trade sales and roughly $1.0B in cash and time deposits. Subsequent news on a new Philadelphia R&D center and J.P. Morgan conference participation drew modest or negative price reactions. The Jan 12, 2026 business update again emphasized CARVYKTI scale and 2026 profitability goals, with only a small positive move.

Market Pulse Summary

The stock dropped -11.4% in the session following this news. A negative reaction despite supportive ...

Analysis

The stock dropped -11.4% in the session following this news. A negative reaction despite supportive CARVYKTI data would fit a pattern where prior positive milestones, such as strong Q3 sales and new facilities, were followed by weak trading, with 4 of the last 5 events showing negative next-day moves. The announcement reiterates meaningful efficacy and long-term outcomes but also devotes extensive space to boxed warnings, including CRS in 84% of treated patients and neurologic toxicities, which might refocus attention on risk and constrain sentiment.

Key Terms

cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, hemophagocytic lymphohistiocytosis, guillain-barré syndrome, +4 more

8 terms

cytokine release syndrome medical

"WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED..."

An intense immune overreaction in which the body's defense system releases a large surge of signaling proteins, causing fever, low blood pressure, breathing trouble or organ stress; imagine the immune system's alarm going into overdrive and flooding the body with emergency responders. Investors care because this side effect can slow or block regulatory approval, increase clinical trial costs and liabilities, limit how widely a therapy can be used, and therefore affect a drug's market value and sales potential.

immune effector cell-associated neurotoxicity syndrome medical

"Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which may be fatal..."

immune effector cell-associated neurotoxicity syndrome (ICANS) is a brain-related side effect that can occur after treatments that activate powerful immune cells, such as engineered cell therapies. It can cause confusion, speech problems, seizures or coma when the immune response unintentionally harms brain function; think of an overenthusiastic security system that starts damaging the house it’s protecting. Investors care because ICANS affects clinical trial results, regulatory approvals, product labeling, treatment adoption, monitoring costs and potential liability, all of which influence a therapy’s commercial value.

hemophagocytic lymphohistiocytosis medical

"Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal..."

Hemophagocytic lymphohistiocytosis (HLH) is a rare, severe condition in which the immune system becomes dangerously overactive and attacks the body's own blood cells and organs, like a thermostat stuck on high. It matters to investors because HLH can drive demand for specialized therapies, shape clinical trial design and regulatory decisions, and create significant treatment costs and liability risks that affect healthcare company valuations and revenue forecasts.

guillain-barré syndrome medical

"Parkinsonism and Guillain-Barré syndrome (GBS) and their associated complications..."

A rare autoimmune disorder in which the body's immune system mistakenly attacks the nerves outside the brain and spinal cord, causing weakness, numbness and, in severe cases, temporary paralysis that can progress rapidly. Investors pay attention to reports of Guillain-Barré syndrome because confirmed cases linked to a drug, vaccine or device can trigger safety investigations, regulatory actions, label changes or trial delays—similar to a safety alarm that can materially affect a company’s product prospects and valuation.

peripheral neuropathy medical

"Peripheral Neuropathy occurred following treatment with CARVYKTI®."

A condition where nerves outside the brain and spinal cord are damaged, causing numbness, tingling, pain or weakness—like faulty wiring that sends mixed or dropped signals between the brain and parts of the body. Investors watch it because it drives demand for drugs, medical devices and diagnostics, shapes clinical trial results and regulatory decisions, and can influence healthcare costs, company revenues and legal risk in related industries.

cranial nerve palsies medical

"Cranial Nerve Palsies occurred following treatment with CARVYKTI®."

Cranial nerve palsies are injuries or dysfunctions of the nerves that emerge directly from the brain and control functions such as eye movement, facial sensation and expression, hearing, and swallowing; think of them as damaged control cables that make parts of the head and face work poorly or not at all. For investors, these findings matter because they can signal a drug’s safety risk, affect regulatory review, prompt label changes or warnings, and influence patient use and company valuation.

progression-free survival medical

"Long-term Progression-Free Survival Benefit With Ciltacabtagene Autoleucel..."

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

bridging therapy medical

"Insights from both clinical trials and real-world experiences, including the role of bridging therapy..."

A bridging therapy is a temporary medical treatment used to control a disease or keep a patient stable while they wait for a planned, longer‑term therapy or a clinical milestone. Think of it as a holding pattern that prevents deterioration until the main treatment is ready; for investors, the availability, effectiveness, and duration of such interim treatments can affect patient numbers, short‑term revenue, trial outcomes, and timing of regulatory or commercial milestones.

AI-generated analysis. Not financial advice.

Six poster presentations highlight CARVYKTI® efficacy, safety, and real-world outcomes across CARTITUDE trials and analyses, reflecting a maturing and expanding body of evidence

SOMERSET, N.J., Jan. 21, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, will present six poster presentations featuring data on CARVYKTI^® (ciltacabtagene autoleucel; cilta-cel) at the Tandem Meetings of ASTCT^® and CIBMTR^®, taking place February 4-7, 2026, in Salt Lake City, UT.

With more than 10,000 patients treated worldwide, CARVYKTI^® continues to generate a growing body of clinical and real-world evidence, informing how the therapy can be optimally used across the multiple myeloma treatment continuum.

These presentations underscore the consistent, durable efficacy and safety of CARVYKTI^® across clinical trials and real-world analyses, with outcomes that are particularly compelling when the therapy is used earlier in patients' multiple myeloma treatment journey. Quality-adjusted survival gains were clinically meaningful and driven by prolonged time without any multiple myeloma treatment, reinforcing the transformative potential of a single CARVYKTI^® infusion to deliver long-lasting benefit for patients with relapsed or refractory multiple myeloma.

"These data reinforce the potential of CARVYKTI to improve outcomes for patients with relapsed or refractory multiple myeloma, demonstrating consistent benefit across efficacy, safety, and quality-adjusted survival—particularly when used earlier in the treatment journey," said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. "Insights from both clinical trials and real-world experiences, including the role of bridging therapy and biomarkers, help refine how we optimize patient outcomes. Together, these data strengthen the case for CARVYKTI as a transformative option in multiple myeloma care with emerging curative potential."

CARVYKTI^® is the first and only BCMA-targeted CAR-T cell therapy approved for the treatment of patients with multiple myeloma who have had at least one prior line of therapy. Globally, CARVYKTI^® is now commercially available in 14 countries.

2026 Tandem Meetings (February 4-7, 2026)
Below is a summary of the six poster presentations. To learn more, visit Legend Biotech at Booth #301 or https://legendbiotech.com

Abstract No.	Title	Information
Poster ID: 234	Quality-Adjusted Survival Analysis of Neurologic Events with Cilta-Cel Versus Standard of Care in Patients with Lenalidomide-Refractory Multiple Myeloma Who Received 1Ð3 Prior Lines of Therapy: CARTITUDE-4 Trial Population	Session Name: Engineered Immune cells - clinical (toxicity, practice, economics, correlative, autoimmunity, malignant, and non malignant indications)  Date: February 5, 2026 Time: 6:30 PM Location: Exhibit Hall AB
Poster ID: 227	Characterization and Management of Non-ICANS Neurologic Events After Ciltacabtagene Autoleucel in Multiple Myeloma	Session Name: Engineered Immune cells - clinical (toxicity, practice, economics, correlative, autoimmunity, malignant, and non malignant indications) Date: February 5, 2026 Time: 6:30 PM Location: Exhibit Hall AB
Poster ID: 207	Bridging Therapy Response and Pre-Lymphodepletion Plasma Cell Burden as Determinants of Ciltacabtagene Autoleucel Safety and Efficacy Outcomes in Relapsed/Refractory Multiple Myeloma	Session Name: Engineered Immune cells - clinical (toxicity, practice, economics, correlative, autoimmunity, malignant, and non malignant indications) Date: February 5, 2026 Time: 6:30 PM Location: Exhibit Hall AB
Poster ID: 216	Ciltacabtagene Autoleucel Out-of-Specification Manufacturing Outcomes Improve With Earlier Lines of Therapy	Session Name: Engineered Immune cells - clinical (toxicity, practice, economics, correlative, autoimmunity, malignant, and non malignant indications) Date: February 5, 2026 Time: 6:30 PM Location: Exhibit Hall AB
Poster ID: 191	Long-term Progression-Free Survival Benefit With Ciltacabtagene Autoleucel in Standard-Risk Relapsed/Refractory Multiple Myeloma	Session Name: Engineered Immune cells - clinical (toxicity, practice, economics, correlative, autoimmunity, malignant, and non malignant indications) Date: February 5, 2026 Time: 6:30 PM Location: Exhibit Hall AB
Poster ID: 203	Effectiveness of Bridging Therapy Corresponds to Improved Outcomes After Ciltacabtagene Autoleucel: Phase 3 CARTITUDE-4 Study of Patients With Relapsed, Lenalidomide-Refractory Multiple Myeloma	Session Name: Engineered Immune cells - clinical (toxicity, practice, economics, correlative, autoimmunity, malignant, and non malignant indications) Date: February 5, 2026 Time: 6:30 PM Location: Exhibit Hall AB

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®.

WARNINGS AND PRECAUTIONS

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. 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 cutoff. 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 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%).

Monitor patients at least daily for 7 days following CARVYKTI^® infusion for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms. Monitor patients for signs or symptoms of ICANS for at least 2 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Advise patients to avoid driving for at least 2 weeks following infusion.

Parkinsonism: Neurologic toxicity with parkinsonism has been reported in clinical trials of CARVYKTI^®. Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, parkinsonism occurred in 3% (8/285), including Grade ≥3 in 2% (5/285) of the patients. Median time to onset of parkinsonism was 56 days (range: 14 to 914 days). Parkinsonism resolved in 1 of 8 (13%) of patients with a median time to resolution of 523 days. Median duration of parkinsonism was 243.5 days (range: 62 to 720 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. The onset of parkinsonism occurred after CRS for all patients and after ICANS for 6 patients.

Parkinsonism occurred in 1% of patients in CARTITUDE-4 (no Grade 3 to 4) and in 6% of patients in CARTITUDE-1 (4% Grade 3 to 4).

Manifestations of parkinsonism included movement disorders, cognitive impairment, and personality changes. Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures. There is limited efficacy information with medications used for the treatment of Parkinson's disease for the improvement or resolution of parkinsonism symptoms following CARVYKTI^® treatment.

Guillain-Barré Syndrome: A fatal outcome following GBS occurred following treatment with CARVYKTI^® despite treatment with intravenous immunoglobulins. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances, and polyradiculoneuritis.

Monitor for GBS. Evaluate patients presenting with peripheral neuropathy for GBS. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS.

Immune Mediated Myelitis: Grade 3 myelitis occurred 25 days following treatment with CARVYKTI® in CARTITUDE-4 in a patient who received CARVYKTI^® as subsequent therapy. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin. Myelitis was ongoing at the time of death from other cause.

Peripheral Neuropathy occurred following treatment with CARVYKTI^®. Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, peripheral neuropathy occurred in 7% (21/285), including Grade ≥3 in 1% (3/285) of the patients. Median time to onset of peripheral neuropathy was 57 days (range: 1 to 914 days). Peripheral neuropathy resolved in 11 of 21 (52%) of patients with a median time to resolution of 58 days (range: 1 to 215 days). Median duration of peripheral neuropathy was 149.5 days (range: 1 to 692 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff.

Peripheral neuropathies occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3 to 4) and in 7% of patients in CARTITUDE-1 (2% Grade 3 to 4). Monitor patients for signs and symptoms of peripheral neuropathies. Patients who experience peripheral neuropathy may also experience cranial nerve palsies or GBS.

Cranial Nerve Palsies occurred following treatment with CARVYKTI^®. Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, cranial nerve palsies occurred in 7% (19/285), including Grade ≥3 in 1% (1/285) of the patients. Median time to onset of cranial nerve palsies was 21 days (range: 17 to 101 days). Cranial nerve palsies resolved in 17 of 19 (89%) of patients with a median time to resolution of 66 days (range: 1 to 209 days). Median duration of cranial nerve palsies was 70 days (range: 1 to 262 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Cranial nerve palsies occurred in 9% of patients in CARTITUDE-4 (1% Grade 3 to 4) and in 3% of patients in CARTITUDE-1 (1% Grade 3 to 4).

The most frequent cranial nerve affected was the 7th cranial nerve. Additionally, cranial nerves III, V, and VI have been reported to be affected.

Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms.

HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)/MACROPHAGE ACTIVATION SYNDROME (MAS): Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, HLH/MAS occurred in 1% (3/285) of patients. All events of HLH/MAS had onset within 99 days of receiving CARVYKTI^®, with a median onset of 10 days (range: 8 to 99 days), and all occurred in the setting of ongoing or worsening CRS. The manifestations of HLH/MAS included hyperferritinemia, hypotension, hypoxia with diffuse alveolar damage, coagulopathy and hemorrhage, cytopenia, and multi-organ dysfunction, including renal dysfunction and respiratory failure.

Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematologic parameters in patients with HLH/MAS and transfuse per institutional guidelines. Fatal cases of HLH/MAS occurred following treatment with CARVYKTI^®.

HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards.

PROLONGED AND RECURRENT CYTOPENIAS: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI® infusion.

Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, Grade 3 or higher cytopenias not resolved by Day 30 following CARVYKTI^® infusion occurred in 62% (176/285) of the patients and included thrombocytopenia 33% (94/285), neutropenia 27% (76/285), lymphopenia 24% (67/285), and anemia 2% (6/285). After Day 60 following CARVYKTI^® infusion, 22%, 20%, 5%, and 6% of patients had a recurrence of Grade 3 or 4 lymphopenia, neutropenia, thrombocytopenia, and anemia, respectively, after initial recovery of their Grade 3 or 4 cytopenia. Seventy-seven percent (219/285) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia. Sixteen and 25 patients had Grade 3 or 4 neutropenia and thrombocytopenia, respectively, at the time of death.

Monitor blood counts prior to and after CARVYKTI^® infusion. Manage cytopenias with growth factors and blood product transfusion support according to local institutional guidelines.

INFECTIONS: CARVYKTI^® should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after CARVYKTI^® infusion.

Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, infections occurred in 57% (163/285), including Grade ≥3 in 24% (69/285) of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 6%, bacterial infections in 5%, and fungal infections in 1% of patients. Overall, 5% (13/285) of patients had Grade 5 infections, 2.5% of which were due to COVID-19. Patients treated with CARVYKTI® had an increased rate of fatal COVID-19 infections compared to the standard therapy arm.

Monitor patients for signs and symptoms of infection before and after CARVYKTI^® infusion and treat patients appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 5% of patients after CARVYKTI® infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care, as medically indicated. Counsel patients on the importance of prevention measures. Follow institutional guidelines for the vaccination and management of immunocompromised patients with COVID-19.

Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients with hypogammaglobulinemia. Perform screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) or any other infectious agents if clinically indicated in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.

Reactivation of John Cunningham (JC) virus, leading to progressive multifocal leukoencephalopathy (PML), including cases with fatal outcomes, have been reported following treatment. Perform appropriate diagnostic evaluations in patients with neurological adverse events.

HYPOGAMMAGLOBULINEMIA: can occur in patients receiving treatment with CARVYKTI^®. Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, hypogammaglobulinemia adverse event was reported in 36% (102/285) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 93% (265/285) of patients. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 94% (267/285) of patients treated. Fifty-six percent (161/285) of patients received intravenous immunoglobulin (IVIG) post CARVYKTI® for either an adverse reaction or prophylaxis.

Monitor immunoglobulin levels after treatment with CARVYKTI^® and administer IVIG for IgG <400 mg/dL. Manage per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.
Use of Live Vaccines: The safety of immunization with live viral vaccines during or following CARVYKTI^® treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during CARVYKTI^® treatment, and until immune recovery following treatment with CARVYKTI^®.

HYPERSENSITIVITY REACTIONS occurred following treatment with CARVYKTI^®. Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, hypersensitivity reactions occurred in 5% (13/285), all of which were ²2 Grade. Manifestations of hypersensitivity reactions included flushing, chest discomfort, tachycardia, wheezing, tremor, burning sensation, non-cardiac chest pain, and pyrexia.

Serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) in CARVYKTI^®. Patients should be carefully monitored for 2 hours after infusion for signs and symptoms of severe reaction. Treat promptly and manage patients appropriately according to the severity of the hypersensitivity reaction.

IMMUNE EFFECTOR CELL-ASSOCIATED ENTERCOLITIS (IEC-EC) has occurred in patients treated with CARVYKTI^®. Manifestations include severe or prolonged diarrhea, abdominal pain, and weight loss requiring parenteral nutrition. IEC-EC has been associated with fatal outcome from perforation or sepsis. Manage according to institutional guidelines, including referral to gastroenterology and infectious disease specialists.

In cases of refractory IEC-EC, consider additional workup to exclude alternative etiologies, including T-cell lymphoma of the GI tract, which has been reported in the post marketing setting.

SECONDARY MALIGNANCIES: Patients treated with CARVYKTI^® may develop secondary malignancies. Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, myeloid neoplasms occurred in 5% (13/285) of patients (9 cases of myelodysplastic syndrome, 3 cases of acute myeloid leukemia, and 1 case of myelodysplastic syndrome followed by acute myeloid leukemia). The median time to onset of myeloid neoplasms was 447 days (range: 56 to 870 days) after treatment with CARVYKTI^®. Ten of these 13 patients died following the development of myeloid neoplasms; 2 of the 13 cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. Cases of myelodysplastic syndrome and acute myeloid leukemia have also been reported in the post marketing setting. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI^®. Mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusions, and may include fatal outcomes.

Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Janssen Biotech, Inc., at 1-800-526-7736 for reporting and to obtain instructions on collection of patient samples.

ADVERSE REACTIONS

The most common nonlaboratory adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting. The most common Grade 3 or 4 laboratory adverse reactions (incidence greater than or equal to 50%) include lymphopenia, neutropenia, white blood cell decreased, thrombocytopenia, and anemia.

Please read full Prescribing Information, including Boxed Warning, for CARVYKTI^®.

ABOUT CARVYKTI^® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL)

Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient's own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. The cilta-cel CAR protein features two BCMA-targeting single-domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.ⁱ

In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., a Johnson & Johnson company, to develop and commercialize cilta-cel. In February 2022, cilta-cel was approved by the U.S. Food and Drug Administration (FDA) under the brand name CARVYKTI^® for the treatment of adults with relapsed or refractory multiple myeloma. In April 2024, cilta-cel was approved for the second-line treatment of patients with relapsed/refractory myeloma who have received at least one prior line of therapy, including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide.

In May 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI^® for the treatment of adults with relapsed and refractory multiple myeloma. In September 2022, Japan's Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI^®. Cilta-cel was granted Breakthrough Therapy Designation in the U.S. in December 2019 and in China in August 2020. In addition, cilta-cel received a PRIority MEdicines (PRIME) designation from the European Commission in April 2019. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In March 2022, the European Medicines Agency's Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained on the basis of clinical data demonstrating improved and sustained complete response rates following treatment.

ABOUT CARTITUDE-4

CARTITUDE-4 (NCT04181827) is an ongoing, international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, including a PI and an IMiD.ⁱⁱ  

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.ⁱⁱⁱ In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.^iv While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems, or infections.^v

About Legend Biotech
With over 2,900 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. The company is at the forefront of the CAR-T cell therapy revolution with CARVYKTI^®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Headquartered in the US, Legend is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI's patient access and therapeutic potential. From this platform, the company plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.

Learn more at www.legendbiotech.com and follow us on X (formerly Twitter) and LinkedIn.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech's strategies and objectives, and the benefits of CARVYKTI, including its emerging curative potential. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech's expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third-party partners; uncertainties arising from challenges to Legend Biotech's patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the "Risk Factors" section of Legend Biotech's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 19, 2024. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated, or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

INVESTOR CONTACT:
Jessie Yeung
Tel: (732) 956-8271
jessie.yeung@legendbiotech.com

PRESS CONTACT:
Kim Fox
Tel: (848) 388-8445
media@legendbiotech.com

_______________
ⁱ CARVYKTI™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.
ⁱⁱ ClinicalTrials.Gov. A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). https://www.clinicaltrials.gov/study/NCT04181827. Accessed March 2024.
ⁱⁱⁱ American Cancer Society. "What is Multiple Myeloma?". Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed March 2024.
^iv American Cancer Society. "Key Statistics About Multiple Myeloma." Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html. Accessed March 2024.
^v American Cancer Society. Multiple myeloma: early detection, diagnosis, and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed March 2023.

FAQ

What data will Legend Biotech (LEGN) present on CARVYKTI at the Feb 4-7, 2026 Tandem Meetings?

Six poster presentations covering efficacy, safety, real-world outcomes, bridging therapy, biomarkers, and manufacturing across CARTITUDE studies.

Is CARVYKTI (LEGN) approved and where is it available as of Jan 21, 2026?

CARVYKTI is the first and only BCMA-targeted CAR-T approved for patients with ≥1 prior multiple myeloma therapy and is commercially available in 14 countries.

What safety risks for CARVYKTI are highlighted from CARTITUDE-1 and -4?

Key risks include CRS (84% overall; Grade ≥3 in 4%), neurologic toxicities (24% overall; Grade ≥3 in 7%), parkinsonism, HLH/MAS, prolonged cytopenias, and secondary hematologic malignancies.

What did CARTITUDE-4 report about early mortality with CARVYKTI?

CARTITUDE-4 showed a numerically higher percentage of early deaths within 10 months: 29/208 (14%) in the CARVYKTI arm vs 25/211 (12%) in control.

Do the presentations claim benefits when CARVYKTI is used earlier in treatment?

Yes; the company reports durable efficacy, safety consistency, and clinically meaningful quality-adjusted survival gains that are particularly compelling with earlier use.