Legend Biotech Highlights Recent Business Updates at 44th Annual J.P. Morgan Healthcare Conference

Rhea-AI Summary

Legend Biotech (NASDAQ: LEGN) provided commercial and clinical updates and outlined 2026 priorities ahead of its Jan 14, 2026 J.P. Morgan presentation. Key highlights: CARVYKTI has treated >10,000 patients to date; global availability expanded to >279 sites across 14 markets; Raritan manufacturing expansion adds installed capacity to support treatment of up to 10,000 patients annually. Regulatory labels in the U.S. and EU now include an overall survival benefit from CARTITUDE-4. Median PFS of 50.4 months reported for certain patients. Company expects CARVYKTI franchise profitability in FY2025 and company-wide operating profit in 2026. Cash and time deposits were approximately $1.0 billion as of Sept 30, 2025. First-in-human in vivo dosing completed; in vivo readouts expected 2H 2026.

Positive

• 10,000+ patients treated with CARVYKTI
• Global footprint: >279 sites in 14 markets
• Raritan facility capacity to treat up to 10,000 patients annually
• Median PFS 50.4 months in triple-class-exposed patients after single infusion
• Regulatory labels (U.S. and EU) now include an overall survival benefit
• Company expects company-wide operating profit in 2026

Negative

• Company is not yet company-wide profitable; operating profit is an expectation for 2026
• Key registrational and investigational readouts remain pending (CARTITUDE-6 and in vivo data expected 2H 2026)
• Cash and time deposits of approximately $1.0 billion as of Sept 30, 2025 may limit runway beyond planned 2026 growth

News Market Reaction – LEGN

+0.42%

1 alert

+0.42% News Effect

On the day this news was published, LEGN gained 0.42%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Patients treated: 10,000+ patients Manufacturing capacity: 10,000 patients annually Global sites: 279+ sites +5 more

8 metrics

Patients treated 10,000+ patients CARVYKTI clinical and commercial use to date

Manufacturing capacity 10,000 patients annually Installed capacity at expanded Raritan facility

Global sites 279+ sites CARVYKTI availability across global markets in 2025

Global markets 14 markets Countries where CARVYKTI is available

Median PFS 50.4 months Triple-class-exposed patients after single CARVYKTI infusion

R&D facility size 31,000 square feet New cell therapy R&D facility in Philadelphia

Cash and deposits Approximately $1.0 billion As of September 30, 2025

Profitability timing 2025–2026 CARVYKTI franchise FY 2025 profitability; company-wide in 2026

Market Reality Check

Price: $17.85 Vol: Volume 4,314,422 is about...

high vol

$17.85 Last Close

Volume Volume 4,314,422 is about 2.0x the 20-day average of 2,130,507. high

Technical Price $23.60 is trading below the 200-day MA at $32.38, well under the 52-week high.

Peers on Argus

LEGN gained about 2.5% with elevated volume while close peers were mixed: RYTM u...

1 Up

LEGN gained about 2.5% with elevated volume while close peers were mixed: RYTM up, ABVX sharply higher on momentum scanner, and ABVX/CYTK/MRUS down or volatile on the day. Moves do not show a uniform biotech sector trend.

Common Catalyst Some peers had routine updates (e.g., AXSM revenue preview), but LEGN’s move ties to company-specific commercial and pipeline disclosures at the J.P. Morgan conference.

Historical Context

5 past events · Latest: Dec 17 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 17	Conference appearance	Positive	-1.1%	Announcement of upcoming J.P. Morgan conference presentation and webcast access.
Nov 13	Facility opening	Positive	-0.5%	Opened 31,000-square-foot Philadelphia R&D facility to expand CAR-T research.
Nov 12	Earnings update	Positive	-2.7%	Q3 2025 results with strong CARVYKTI sales and profitability outlook into 2026.
Nov 03	Scientific meeting	Positive	-0.8%	Announcement of 10 ASH presentations on CARVYKTI and allogeneic candidate Lucar-G39D.
Oct 29	Earnings call notice	Neutral	-1.4%	Notification of upcoming Q3 2025 earnings conference call and webcast details.

Pattern Detected

Recent LEGN news and earnings events, including positive CARVYKTI updates and new facilities, have often been followed by modest negative 24-hour price reactions, suggesting a tendency toward sell-the-news or muted responses.

Recent Company History

Over the last few months, Legend Biotech highlighted expansion of its CARVYKTI franchise and infrastructure, including a 31,000-square-foot R&D facility in Philadelphia and commercial scale-up in Ghent. Q3 2025 results showed higher CARVYKTI sales, about $1.0 billion in cash and time deposits, and a path toward profitability in 2026. Multiple ASH 2025 presentations underscored long-term benefits and broader use of CARVYKTI. Today’s J.P. Morgan update reiterates those themes with added detail on profitability timing and in vivo pipeline progress.

Market Pulse Summary

This announcement underscores Legend Biotech’s transition from growth to scale, highlighting over 10...

Analysis

This announcement underscores Legend Biotech’s transition from growth to scale, highlighting over 10,000 CARVYKTI-treated patients, capacity for 10,000 annual treatments at the expanded Raritan site, and availability at more than 279 sites in 14 markets. Management reiterated expectations for CARVYKTI franchise profitability in FY 2025 and company-wide profitability in 2026, while advancing allogeneic and in vivo CD20/CD19 programs. Key metrics to track include patient volumes, margin expansion, and upcoming first-in-human data from the in vivo platform.

Key Terms

car-t cell therapy, progression-free survival, pfs, overall survival, +4 more

8 terms

car-t cell therapy medical

"multiple myeloma CAR-T cell therapy, with its continued record-breaking"

A therapy that takes a patient’s own immune cells, reprograms them in a lab to recognize and attack specific disease cells, then returns them to the body—think of training and equipping a guard dog to find a particular intruder. Investors care because these treatments can offer dramatic clinical benefits, carry high development and manufacturing costs, and create new, often lucrative markets if they receive regulatory approval and payer support.

progression-free survival medical

"achieved a median progression-free survival (PFS) of 50.4 months"

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.

pfs medical

"achieved a median progression-free survival (PFS) of 50.4 months"

Progression-free survival (PFS) is a clinical-trial measure that records how long, on average, patients live without their disease getting worse after starting a treatment. For investors, PFS acts like a stopwatch of a drug’s effectiveness: longer PFS can signal meaningful patient benefit, improve chances of regulatory approval or label strength, and raise a drug’s commercial value, while shorter or unchanged PFS can weigh on a company’s prospects.

overall survival medical

"approval to include overall survival benefit for CARVYKTI"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

non-hodgkin lymphoma medical

"dual-targeting in vivo CAR-T cell therapy for non-Hodgkin lymphoma"

A group of cancers that start in the lymphatic system, which is part of the body’s defense network of nodes and vessels; malignant cells multiply in lymph nodes, spleen or blood and can impair immune function. It matters to investors because diagnosis rates, available treatments, and regulatory approvals drive demand for drugs, influence clinical trial outcomes, and can shift revenue, development risk and valuation for companies in biotech, diagnostics and healthcare.

phase 3 medical

"data from the landmark Phase 3 CARTITUDE-4 study in patients"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

investigational new drug (ind) regulatory

"Targeting multiple investigational new drug (IND) filings for oncology"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

nccn guidelines medical

"The latest NCCN guidelines recommend talquetamab as a bridging"

NCCN Guidelines are evidence-based recommendations for cancer diagnosis, treatment and care developed by a network of cancer specialists; think of them as an expert-approved roadmap clinicians use to choose therapies. They matter to investors because inclusion or alignment with these guidelines can speed clinical adoption, influence insurance coverage and reimbursement, and signal clinical credibility — all of which affect a treatment’s commercial potential and a company’s market value.

AI-generated analysis. Not financial advice.

• Exceeded 10,000 patients treated to date with CARVYKTI^® (ciltacabtagene autoleucel; cilta-cel)
• Increased CARVYKTI^® manufacturing capacity with the physical expansion of the Raritan facility, now the largest cell therapy manufacturing facility in the U.S.
• Profitability expected in 2026, driven by continued CARVYKTI^® revenue growth and operating margin expansion
• Treated first patient with in vivo pipeline candidate in investigator-initiated trial
• Preclinical data from primates provided early validation for CD20/CD19 dual-targeting in vivo CAR-T cell therapy for non-Hodgkin lymphoma
  

SOMERSET, N.J., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today provided an update on the Company's recent commercial and clinical progress and outlined its strategic priorities for 2026. These updates will be discussed as part of the Company's presentation at the 44^th Annual J.P. Morgan Healthcare Conference in San Francisco, CA, on Wednesday, January 14, 2026, at 9:00 a.m. PT.

“CARVYKTI cemented its status as the undisputed leader in multiple myeloma CAR-T cell therapy, with its continued record-breaking performance culminating in the achievement of more than 10,000 patients treated earlier this year,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “Legend Biotech is poised for transformative growth in 2026, as we work to achieve profitability this year by driving global adoption of CARVYKTI. We’re also committed to leveraging our proven CAR-T development platform to frontline multiple myeloma and promising new in vivo and allogeneic opportunities to extend our leadership in cell therapy innovation.”

2026 Strategic Priorities and Recent Accomplishments

Maximize CARVYKTI^® Market Leadership

• Treated 10,000+ clinical and commercial patients to date with CARVYKTI^®.
• Expanded CARVYKTI^® global footprint in 2025, bringing total availability to more than 279 sites across 14 global markets.
  • Continued globalization planned for 2026.
• Continued to drive community and outpatient adoption of CARVYKTI^® and uptake in earlier lines, with United States community and regional hospitals.
• Completed physical expansion of the Raritan facility, marking the largest cell therapy manufacturing facility in the U.S. and providing installed capacity to support treatment of up to 10,000 patients annually.
• Received U.S. Food and Drug Administration (FDA) and European Commission (EC) approval to include overall survival benefit for CARVYKTI^® versus standard therapies in the label.
  • Label update was supported by data from the landmark Phase 3 CARTITUDE-4 study in patients with relapsed/refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy (pLOT).
• Presented new clinical and translational data from CARTITUDE-1 and CARTITUDE-4 at the 67^th American Society of Hematology (ASH) Annual Meeting in December 2025, reinforcing the long-term benefits of CARVYKTI^® and improved outcomes associated with earlier use.
  • Triple-class-exposed patients treated with three pLOT from the CARTITUDE-1 and CARTITUDE-4 trials achieved a median progression-free survival (PFS) of 50.4 months following a single infusion of CARVYKTI^®.
  • Additional findings from CARTITUDE-1 and CARTITUDE-4 demonstrated that patients treated earlier, after one or two pLOT, exhibited greater immune fitness and a more immunocompetent tumor microenvironment, potential biological indicators of longer PFS.
• The latest NCCN guidelines recommend talquetamab as a bridging therapy before CAR-T treatment for people with relapsed/refractory multiple myeloma. This approach helps keep patients eligible for CARVYKTI^® and improves outcomes, especially for those with aggressive disease.
• Completed enrollment of Phase 3 CARTITUDE-6 registrational trial in newly-diagnosed MM patients who are transplant eligible in August 2025.
  

Advance Cell Therapy Innovation

• Presented promising first-in-human results from allogeneic CAR-T candidate LUCAR-G39D at the 67^th ASH Annual Meeting, demonstrating encouraging safety and efficacy in B-cell non-Hodgkin lymphoma.
• Opened 31,000-square-foot, state-of-the-art cell therapy R&D facility in Philadelphia, Pennsylvania, to support the Company’s pipeline expansion across oncology and immunology indications and in vivo approaches.
• Dosed first patient with in vivo platform technology, a dual CD20/CD19-targeted cell therapy, within six months of candidate selection.
  • First-in-human data expected starting in the second half of 2026.
• Targeting multiple investigational new drug (IND) filings for oncology and autoimmune indications starting in 2H 2026.
  

Drive Profitability

• Anticipate CARVYKTI^® franchise FY 2025 profitability.
• Expect company-wide operating profit in 2026.
• Cash and cash equivalents, and time deposits were approximately $1.0 billion as of September 30, 2025, which the Company believes will provide financial runway beyond 2026.
  

Presentation at the 44^th J.P. Morgan Healthcare Conference

Dr. Huang will deliver Legend Biotech’s presentation at the 44^th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 9:00 a.m. PT. The live webcast will be available to investors and other interested parties by accessing the Investor Relations section of Legend’s website. The webcast replay will be available approximately 48 hours after the webcast.

About Legend Biotech

With more than 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: CARVYKTI^® and LUCAR-G39D, including Legend Biotech’s expectations for market expansion for CARVYKTI^® and order volume; Legend Biotech’s ability to fund its operations into 2026 and to achieve company-wide profitability in 2026 and Carvykti-related profitability by end of 2025; the timing, progress and results of preclinical studies and clinical trials for the Company’s product candidates; and statements related to the potential benefits of Legend Biotech’s product candidates. . 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 11, 2025. 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

FAQ

How many patients has CARVYKTI (LEGN) treated as of January 2026?

CARVYKTI has treated more than 10,000 patients to date.

What manufacturing capacity did Legend Biotech announce for CARVYKTI at the Raritan facility?

The Raritan expansion provides installed capacity to support treatment of up to 10,000 patients annually.

When does Legend Biotech expect company-wide profitability (LEGN)?

Legend Biotech expects company-wide operating profit in 2026, with CARVYKTI franchise profitability anticipated for FY 2025.

What pivotal clinical benefit was added to the CARVYKTI label for LEGN in the U.S. and EU?

Regulatory updates in the U.S. and EU include an added overall survival benefit versus standard therapies based on CARTITUDE-4.

What is the reported median progression-free survival (PFS) for certain patients treated with CARVYKTI?

Triple-class-exposed patients treated with three prior lines of therapy achieved a median PFS of 50.4 months after a single CARVYKTI infusion.

When are Legend Biotech’s first-in-human in vivo data expected for its CD20/CD19 candidate (LEGN)?

First-in-human in vivo readouts are expected beginning in the second half of 2026.