Legend Biotech Highlights Recent Business Updates at 44th Annual J.P. Morgan Healthcare Conference
MWN-AI** Summary
Legend Biotech Corporation (NASDAQ: LEGN) showcased significant progress at the 44th Annual J.P. Morgan Healthcare Conference, detailing major achievements and strategic ambitions for 2026. The company’s CARVYKTI® (ciltacabtagene autoleucel) has reached a milestone of over 10,000 patients treated and continues to dominate the CAR-T cell therapy space for multiple myeloma. With enhanced manufacturing capabilities following an expansion of their Raritan facility—now the largest cell therapy manufacturing site in the U.S.—Legend Biotech aims to boost CARVYKTI® production to support up to 10,000 patients annually.
Dr. Ying Huang, CEO, emphasized a vision for profitability by 2026, driven by CARVYKTI® revenue and expanding operational margins. The company’s strategic goals include maximizing CARVYKTI® market leadership through increased global access and deeper penetration into community healthcare settings, while reinforcing the product’s position with FDA and European Commission approval for overall survival benefits compared to standard therapies.
Clinical advancements included enrolling the first patient in an investigator-initiated trial with an in vivo candidate while presenting promising preclinical data on a dual-targeting CAR-T cell therapy design for non-Hodgkin lymphoma. The company also introduced notable findings from the CARTITUDE trials, validating improved outcomes when CARVYKTI® is administered earlier in treatment.
Furthermore, the financial outlook appears robust, with Legend Biotech reporting over $1 billion in cash reserves as of September 30, 2025, allowing sustained growth and investment into new therapeutic developments. All these developments position Legend Biotech as a transformative force in the ongoing evolution of cancer treatment through innovative therapies and expansion strategies.
MWN-AI** Analysis
Legend Biotech Corporation (NASDAQ: LEGN) has recently highlighted significant advancements in its business during the 44th Annual J.P. Morgan Healthcare Conference. One of the standout achievements is the milestone of treating over 10,000 patients with CARVYKTI® (ciltacabtagene autoleucel), solidifying its position as a leading therapy in the CAR-T cell space for multiple myeloma. The increased manufacturing capacity at the recently expanded Raritan facility, now the largest of its kind in the U.S., supports ambitions to treat up to 10,000 patients annually—an essential step toward driving revenue growth.
Looking ahead, Legend anticipates reaching profitability by 2026, primarily fueled by continued growth in CARVYKTI® revenue and improvements in operating margins. Given the favorable regulatory updates, including the U.S. FDA and European Commission's endorsement of CARVYKTI® highlighting its overall survival benefit, the therapeutic's market penetration is likely to strengthen.
The company’s strategic priorities underscore a two-pronged approach: enhancing CARVYKTI® market leadership while diversifying its pipeline with innovative therapies, such as its dual-targeting CAR-T cell therapy for non-Hodgkin lymphoma. The encouraging preclinical data and the company’s investment in new manufacturing and research facilities suggest a robust R&D platform poised for expansion in oncology and beyond.
Investors should closely monitor these developments, as they indicate significant upside potential. The current valuation reflects a company on the cusp of vital growth, particularly as new treatments enter clinical trials and as market adoption accelerates. For potential investors, Legend Biotech presents a compelling opportunity, particularly with its cash reserves of approximately $1 billion, providing a solid runway for upcoming initiatives. Careful consideration of the stock could yield favorable returns as the company moves closer to achieving its strategic goals.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- 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 44th 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 67th 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 67th 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 44th J.P. Morgan Healthcare Conference
Dr. Huang will deliver Legend Biotech’s presentation at the 44th 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 does Legend Biotech Corporation LEGN plan to sustain the momentum of CARVYKTI® after surpassing 10,000 treated patients, and what are the key strategies for increasing global adoption in 2026?
What specific milestones does Legend Biotech Corporation LEGN expect to achieve in its pursuit of profitability in 2026, particularly in relation to CARVYKTI® sales growth?
Can Legend Biotech Corporation LEGN share insights on how the expansion of the Raritan facility will impact the production capacity and accessibility of CARVYKTI® for patients in various regions?
How will the promising preclinical data on the in vivo dual-targeting CAR-T cell therapy influence Legend Biotech Corporation LEGN's future development pipeline and overall research focus in oncology and immunology?
**MWN-AI FAQ is based on asking OpenAI questions about Legend Biotech Corporation (NASDAQ: LEGN).
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