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SummaryOn July 15, J&J, a Legend Biotech Corporation partner, announced continued strong demand for Carvykti.Sales of this CAR-T cell therapy were $657 million in the second quarter, up 10.1% quarter-on-quarter and 49.7% year-on-year.Legend hasn't yet announced when it will publish its second-quarter report, but given Carvykti's sales, I expect it to beat consensus estimates.Moreover, LB2501, a CD19/CD20 CAR T-cell therapy, has shown promising results in the Phase 1 trial in the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma.In this article, I explain why I continue to cover Legend Biotech with a Strong Buy rating. Tom Merton/OJO Images via Getty Images

Following my article "Legend Biotech: Undervalued Leader In The CAR-T Race," Legend Biotech Corporation (LEGN) shares rose as much as 55.8% to $37.2.

But over the past 5 weeks, they've returned to the -1σ band

3.49K Followers

Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

June 17, 2026 21:21 ET  | Source: Legend Biotech USA Inc.

BRIDGEWATER, N.J., June 17, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (“Legend Biotech” or the “Company”), a global leader in cell therapy, today announced the pricing of an underwritten public offering of 7,700,000 American Depositary Shares (“ADSs”), each representing two ordinary shares of the Company, at a public offering price of $29.35 per ADS. In addition, Legend Biotech has granted the underwriters a 30-day option to purchase up to an additional 1,155,000 ADSs at the public offering price, less underwriting discounts and commissions. All of the ADSs are being offered by Legend Biotech. The gross proceeds to Legend Biotech from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Legend Biotech, are expected to be approximately $226 million, excluding any proceeds from the exercise of the underwriters’ option to purchase additional ADSs. The offering is expected to close on June 23, 2026, subject to customary closing conditions.

Morgan Stanley, Jefferies, Citigroup and Deutsche Bank Securities are serving as joint book-running managers for the offering.

The ADSs are being offered by Legend Biotech pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission (“SEC”). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on June 17, 2026. The final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. A copy of the final prospectus supplement and the accompanying prospectus can be obtained, when available, from Morgan Stanley Asia Limited, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, email: [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone: (877) 821-7388, or by email: [email protected]; Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone: (800) 831-9146; or Deutsche Bank Securities Inc., Attention: Prospectus Group, 1 Columbus Circle, New York, NY 10019, by telephone: (800) 503-4611, or by email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Legend Biotech

With over 3,000 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. Legend Biotech 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. Centered in the United States, Legend Biotech 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, Legend Biotech plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.

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, may 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 the closing of and expected gross proceeds from the public offering. 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, including: the uncertainties related to market conditions and the completion of the proposed public offering on the anticipated terms or at all, and the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on March 10, 2026 as well as in Legend Biotech’s other filings with the SEC. 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 hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information in this press release as current or accurate after its publication date.

INVESTOR CONTACT:
Jessie Yeung
Tel: (732) 956-8271
[email protected]

PRESS CONTACT:
Kim Fox
Tel: (848) 388-8445
[email protected]

Achieved 100% ORR and 83.3% CR rate at dose level 2 following a single infusion in patients with relapsed/refractory B-NHL in an ongoing Phase 1 study
Single infusion of LB2501 generated dose-dependent in vivo CAR-T expansion without lymphodepletion
No dose-limiting toxicities, serious adverse events, ICANS, or deaths were reported; infusion-related reactions and CRS were Grade 1–2, and none required glucocorticoids for CRS management
Additional translational data showed rapid vector clearance, polyclonal vector integration, and no evidence of non-specific transduction
Proof-of-concept progress demonstrates leadership in next-generation cell therapies, with results presented in a late-breaking session at EHA 2026

BRIDGEWATER, N.J., June 15, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced first clinical proof-of-concept data for LB2501, its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). The results are being presented today in a late-breaking session at the European Hematology Association (EHA) 2026 Congress (Abstract #LB5006).

In the ongoing Phase 1 study, a single infusion of LB2501 generated dose-dependent in vivo CAR-T expansion without lymphodepletion. At the higher dose level (DL2), LB2501 achieved a 100% objective response rate (ORR) (6/6) and an 83.3% complete response rate (CR) (5/6), with all responses ongoing at the time of data cutoff. LB2501 also showed a favorable safety profile, with no dose-limiting toxicities (DLTs), serious adverse events (SAEs), immune effector cell-associated neurotoxicity syndrome (ICANS), or deaths reported.

“In vivo CAR-T represents a compelling frontier in cell therapy, enabling the generation of CAR-T cells directly within the patient, with the potential to simplify treatment and expand access over time,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “LB2501 is our step toward realizing that vision and reflects further progress toward our goal of leading the future of cell therapy. Backed by the commercial and scientific foundation we have built with CARVYKTI, we are well-positioned to advance this next generation of CAR-T delivery. These early data, with deep responses from a single infusion across patients, give us confidence in the path ahead.”

LB2501 Demonstrates In Vivo CAR-T Generation and Early Clinical Activity

In an ongoing Phase 1 study, 12 patients with R/R B-NHL received LB2501 across two dose levels, DL1 (n=6) and DL2 (n=6). Patients had received a median of three prior lines of therapy, and 58.3% were refractory to their most recent treatment. The open-label, multi-center, dose-escalation study is evaluating safety, recommended Phase 2 dose, pharmacokinetics, and preliminary efficacy in adults with R/R B-NHL. The study was conducted without lymphodepletion.

At DL2, LB2501 achieved a 100% ORR (6/6) and an 83.3% CR rate (5/6), with responses observed across patients with diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL). Across both dose levels, the ORR was 50.0% (6/12), and the CR rate was 41.7% (5/12). At the time of data cutoff, all responses at DL2 were ongoing.

LB2501 showed a favorable safety profile. No DLTs, SAEs, ICANS, or deaths were reported. Infusion-related reactions (IRR) and cytokine release syndrome (CRS) were the most common adverse events of special interest and were all Grade 1–2. Infusion-related reactions occurred in 75.0% (9/12) of patients overall, with a median onset of 1.4 hours after infusion and a median recovery time of 18.6 hours. CRS occurred in 66.7% (8/12) of patients overall, with a median onset at Day 11 and a median duration of 4.5 days. IRR and CRS were all Grade 1–2, no patients required glucocorticoids for CRS management. Four patients received tocilizumab.

Pharmacokinetic analyses showed dose-dependent in vivo CAR-T expansion in 100% (6/6) of patients at DL2 and 83% (5/6) of patients at DL1. CAR-T cells remained detectable in peripheral blood for up to 116 days. Viral copy number in peripheral blood peaked immediately after infusion and decreased to undetectable concentrations within 24 hours.

Additional translational analyses further characterized the in vivo profile of LB2501. No evidence of non-specific transduction was detected in NK cells or other non-T/B/NK lymphocyte populations. Vector integrations were highly polyclonal and diverse. These findings support proof-of-concept for in vivo T-cell engineering, with polyclonal vector integration and rapid vector clearance.

“These early clinical findings are encouraging in a heavily pretreated relapsed or refractory B-cell non-Hodgkin lymphoma population,” said Lei Fan, M.D., Ph.D., Professor, Doctoral Supervisor, and Administrative Director, Hematology Department, Jiangsu Province Hospital, Nanjing, China. “The responses observed at the higher dose level achieved a 100% objective response rate, together with a favorable safety profile and the absence of lymphodepletion, support further investigation of LB2501 as a novel in vivo CAR-T approach. The additional pharmacokinetic and translational findings presented at EHA further support the feasibility of generating CAR-T cells directly within the patient.” ‡

ABOUT LB2501
LB2501 is an investigational, potential first-in-class CD19/CD20 dual-targeting in vivo CAR-T therapy designed to generate CAR-T cells directly within the patient following a single intravenous infusion. It is being evaluated in an ongoing Phase 1, open-label study (NCT07002112) in patients with relapsed/refractory B-cell malignanciesi to assess safety, tolerability, and preliminary efficacy.[i]

ABOUT B-CELL NON-HODGKIN LYMPHOMA
Non-Hodgkin lymphoma (NHL) is a group of cancers that originate in lymphocytes, a type of white blood cell that plays a key role in the body’s immune system.ii B-cell lymphomas account for approximately 85% of NHL cases and arise from abnormal growth of B lymphocytes (B cells), which are responsible for producing antibodies. These malignancies include a range of subtypes that vary in aggressiveness, from slow-growing to highly aggressive disease.iii

While treatment advances have improved outcomes for some patients, those with relapsed or refractory B-cell NHL, particularly after multiple lines of therapy, often face limited options.

ABOUT LEGEND BIOTECH
With over 3,000 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. Legend Biotech 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. Centered in the United States, Legend Biotech 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, Legend Biotech plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.

Learn more at https://legendbiotech.com and follow us on X, Instagram, 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, the Phase 1 clinical trial of LB2501, and the potential benefits of LB2501, including the reproducibility and durability of any favorable results initially seen in patients dosed to date in clinical trials, and LB2501’s potential to be first-in-class. 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 Legend Biotech’s 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 10, 2026. 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.

‡ Lei Fan, M.D., Ph.D., Professor, Doctoral Supervisor, and Administrative Director, Hematology Department, Jiangsu Province Hospital, Nanjing, China, has provided consulting and advisory services to Legend Biotech; he has not been paid for any media work.

INVESTOR CONTACT:
Jessie Yeung
Tel: (732) 956-8271
[email protected]

PRESS CONTACT:
Kim Fox
Tel: (848) 388-8445
[email protected]

______________________________
i ClinicalTrials.Gov. The CD19/ CD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed/Refractory B-cell Malignancies. https://clinicaltrials.gov/study/NCT07002112. Accessed May 2026
ii American Cancer Society. “What Is Non-Hodgkin Lymphoma?”. Available at: https://www.cancer.org/cancer/types/non-hodgkin-lymphoma/about/what-is-non-hodgkin-lymphoma.html.Accessed May 2026.
iii American Cancer Society. “Types of B-cell Lymphoma”. Available at: https://www.cancer.org/cancer/types/non-hodgkin-lymphoma/about/b-cell-lymphoma.html. Accessed May 2026.

ArrowMark Colorado Holdings LLC lowered its holdings in Legend Biotech Corporation Sponsored ADR (NASDAQ: LEGN) by 4.6% during the third quarter, according to its most recent filing with the Securities and Exchange Commission. The fund owned 938,678 shares of the company's stock after selling 44,832 shares during the quarter. ArrowMark Colorado Holdings LLC

Legend Biotech (LEGN +4.07%) was one of the healthier healthcare stocks on the market as the trading week kicked off on Monday. Not one, but two, bullish analyst updates helped propel the biotech stock to a sturdy 18% gain on Monday, a performance that sharply contrasted with the 0.2% slump of the S&P 500 index.

A pharmaceutical giant swoops That morning, both H.C. Wainwright's Mitchell Kapoor and RBC Capital's Leonid Timashev reiterated their equivalents of buy recommendations on Legend. Of the pair, Timashev is the more bullish, as his price target is $62 per share, while Kapoor's is $50.

Image source: Getty Images.

According to reports, the RBC prognosticator was inspired by Eli Lilly's announcement early Monday that it is buying clinical-stage oncology drug developer Kelonia Therapeutics in a deal potentially worth up to $7 billion. Like Kelonia, Legend harnesses chimeric antigen receptor T-cell therapy (CAR-T) in its investigational drugs.

As for H.C. Wainwright's Kapoor, according to reports, he waxed bullish in his update about the generally encouraging progress of all Legend pipeline programs. He noted that data from an early stage in vivo trial of the company's CD19/CD20 should be published in the near future. If successful, this form of therapy could hold great promise for the treatment of certain cancers.

Today's Change

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Potentially legendary It's understandable that, as Timashev pointed out, the Eli Lilly/Kelonia deal sparked excitement about Legend's future. For once, though, this isn't just hope or hype -- Legend has innovative, very promising science supporting its pipeline programs. This is absolutely a biotech to watch, in my view, purely on the strength of those programs.

Eric Volkman has no position in any of the stocks mentioned. The Motley Fool recommends Legend Biotech. The Motley Fool has a disclosure policy.

In my opinion, Legend Biotech Corporation is an attractive acquisition target for Johnson & Johnson. Carvykti, which they are jointly developing, is quickly catching up in sales with Darzalex, J&J's blockbuster for the treatment of multiple myeloma. So, sales of Carvykti reached $597 million in Q1, up 61.8% year-on-year, beating my 'best case' scenario by $15 million.

Leading experts across cell therapy, oncology, and immunology will provide strategic input as Legend advances and expands beyond its current portfolio May 04, 2026 08:00 ET  | Source: Legend Biotech USA Inc.

SOMERSET, N.J., May 04, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced the engagement with a group of distinguished scientific advisors who will provide strategic input as Legend advances its pipeline and future research priorities.

The advisors, who include Renier Brentjens, M.D., Ph.D., Spencer Fisk, Carl June, M.D., Maximilian F. Konig, M.D., Anthony Polverino, Ph.D., and Georg Schett, M.D., bring deep expertise spanning oncology, immunology, development, and manufacturing of cell-based therapies.

“These advisors bring an exceptional breadth of experience that will help guide our scientific priorities and identify new opportunities for innovation,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “As we look to advance and expand beyond our current portfolio, their perspectives will help shape our long-term scientific direction as we build a diversified, next-generation cell therapy pipeline focused on areas of high unmet need.”

Through ongoing engagement, these advisors will contribute their perspectives across emerging science, translational research, clinical development, and manufacturing priorities, including the identification of future areas of unmet need.

Collectively, these advisors reinforce the evolution of Legend Biotech as an end-to-end cell therapy company and the advancement of a next-generation pipeline with the potential to expand patient access and unlock new therapeutic possibilities.

About the Advisors

Renier Brentjens, M.D., Ph.D. – A pioneer in CAR-T cell therapy, Dr. Brentjens serves as Deputy Director and Chair of the Department of Medicine at Roswell Park Comprehensive Cancer Center. He pioneered the early clinical development of CD19-directed CAR-T cell therapies, developed armored CAR-T cells to overcome the tumor microenvironment, and is actively exploring preclinical and clinical work advancing CAR-Ts against solid tumor antigens. Recently, Dr. Brentjens was named a recipient of the Warren Alpert Foundation Prize for his pioneering applications of CAR-T cell therapy.Spencer Fisk – A seasoned CMC and technical operations leader, Mr. Fisk currently serves as Chief Technology & Quality Officer at Ottimo Pharma. At Novartis, he initiated CMC development and later led the manufacturing readiness for the approval and global commercial launch of the first FDA-approved CAR-T cell therapy for acute lymphoblastic leukemia (ALL). He brings more than 35 years of industry experience from Merck, Genentech, and other leading and innovative biopharmaceutical organizations.Carl June, M.D. – A globally recognized immunologist and pioneer of CAR-T therapy, Dr. June led the development of the first U.S. Food and Drug Administration (FDA)-approved CAR-T therapy and co-founded several biotech companies. He is Director of the Center for Cellular Immunotherapies at the University of Pennsylvania and Director of the Parker Institute for Cancer Immunotherapy. Dr. June’s lab studies various mechanisms of lymphocyte activation related to immune tolerance and adoptive immunotherapy for cancer and chronic infection.Maximilian F. Konig, M.D. – A physician-scientist, Director of the Cellular Therapy Program (Autoimmunity), and Co-Director of the Center for Autoimmunity and Immuno-Oncology at Johns Hopkins University, Dr. Konig specializes in rheumatology and immunology. His lab pioneers the development of antigen-specific and precision immunotherapy platforms for autoimmune diseases. He is also the scientific co-founder of Winnow Therapeutics.Anthony Polverino, Ph.D. – A veteran R&D leader in oncology and immunology, Dr. Polverino previously served as Chief Scientific Officer at Zymeworks and Kite Pharma, where he contributed to the approval of a CD19-targeted CAR-T cell therapy. He brings more than two decades of research leadership experience from Amgen and other biopharmaceutical organizations.Georg Schett, M.D. – A leading rheumatologist and immunologist, Dr. Schett serves as Professor of Internal Medicine, Head of the Department of Medicine 3 - Rheumatology and Immunology at Uniklinikum Erlangen and Vice President of Research at Friedrich-Alexander-Universität Erlangen-Nürnberg. He pioneered the application of CD19-directed CAR-T therapy in autoimmune diseases, including early clinical studies demonstrating drug-free remission in patients with severe lupus. About Legend Biotech
With over 3,000 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. Legend Biotech 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. Centered in the United States, Legend Biotech is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI® patient access and therapeutic potential. From this platform, Legend Biotech plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.

Learn more at https://legendbiotech.com and follow us on X 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 advancement of its pipeline and product portfolio. 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 10, 2026. 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
[email protected]

PRESS CONTACT:
Kim Fox
Tel: (848) 388-8445
[email protected]

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Legend Biotech Corp (NASDAQ:LEGN) reported downbeat results for the first quarter on Tuesday.

The company posted quarterly losses of 3 cents per share which missed the analyst consensus estimate of losses of 2 cents per share. The company reported quarterly sales of $305.100 million which missed the analyst consensus estimate of $307.035 million.

Legend Biotech shares rose 1.3% to trade at $28.63 on Wednesday.

These analysts made changes to their price targets on Legend Biotech following earnings announcement.

RBC Capital analyst Leonid Timashev maintained Legend Biotech with an Outperform rating and raised the price target from $62 to $64. Morgan Stanley analyst Matthew Harrison maintained the stock with an Overweight rating and lowered the price target from $49 to $48. TD Cowen analyst Yaron Werber maintained the stock with a Hold and raised the price target from $21 to $29. Considering buying LEGN stock? Here’s what analysts think:

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First Beijing Investment Ltd disclosed a new position in Legend Biotech (LEGN +4.07%), acquiring 2,296,335 shares in the first quarter, with the estimated trade valued at $43.78 million based on average quarterly pricing, according to a May 13, 2026, SEC filing.

Legend Biotech develops cell therapies for cancer, with a pipeline spanning hematologic malignancies and solid tumors.

Initiated new stake: 2,296,335 shares; estimated trade value $43.78 million (based on quarterly average price)Quarter-end position value at $41.54 million, representing a net valuation change that includes price movementsTrade represented a 1.89% increase in 13F reportable assets under managementPost-trade: 2,296,335 shares held, valued at $41.54 millionPosition accounts for 1.79% of 13F AUM, which places it outside the fund's top five holdingsWhat happenedAccording to an SEC filing dated May 13, 2026, First Beijing Investment Ltd established a new stake in Legend Biotech, purchasing 2,296,335 shares. The estimated transaction value was $43.78 million, calculated using the average closing price for the first quarter. The quarter-end value of this position stood at $41.54 million, reflecting both purchase activity and share price movement during the period.

What else to knowNew position: stake represents 1.79% of 13F reportable assets under management as of March 31, 2026Top holdings after the filing:NASDAQ: PDD: $832.68 million (35.9% of AUM)NYSE: YMM: $747.01 million (32.2% of AUM)NYSE: EDU: $509.40 million (22.0% of AUM)NYSE: RLX: $132.29 million (5.7% of AUM)NASDAQ: KSPI: $32.17 million (1.4% of AUM)As of May 15, 2026, Legend Biotech shares were priced at $27.55, down 0.5% over the prior year, underperforming the S&P 500 by 25.7 percentage pointsCompany OverviewMetricValuePrice (as of market close 2026-05-15)$27.55Market Capitalization$5.08 billionRevenue (TTM)$1.14 billionNet Income (TTM)($250.98 million)Company SnapshotLegend Biotech develops and commercializes novel cell therapies, including its lead CAR-T product candidate for multiple myeloma and a pipeline targeting various hematologic malignancies and solid tumors.The company generates revenue primarily through the development and licensing of its cell therapy portfolio, leveraging strategic collaborations such as its agreement with Janssen Biotech for ciltacabtagene autoleucel.Legend Biotech targets oncology patients, healthcare providers, and pharmaceutical partners in the United States, China, and international markets.Legend Biotech Corporation is a clinical-stage biopharmaceutical company focused on advancing innovative cell therapies for cancer and related diseases. The company leverages proprietary CAR-T technologies and strategic partnerships to address high unmet medical needs in oncology. With a growing portfolio and international presence, Legend Biotech aims to establish a competitive position in the global biotechnology sector.

What this transaction means for investorsFirst Beijing runs a hyper-concentrated book — three names make up roughly 90% of its reported assets, all in Chinese tech and consumer. Adding Legend Biotech at 1.79% of AUM is a toe-dip into a different corner of the China ADR universe, not a conviction call. The stock had already given back meaningful ground before this position was opened, which is worth knowing, but the filing doesn't tell you why First Beijing bought or what their target is. A small new position from a fund this concentrated says less than the same allocation would from a more diversified manager. If you're trying to decide whether Legend Biotech belongs in your portfolio, the CAR-T pipeline and the Janssen partnership are the questions that matter — this 13F just tells you one institution got off the sidelines at a depressed price.

Seena Hassouna has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Joint Stock Kaspi.kz and Legend Biotech. The Motley Fool has a disclosure policy.

CPI Data Sparks Rally in Biotech StocksLegend Biotech NASDAQ: LEGN used an investor and analyst event to highlight long-term data and physician perspectives supporting broader use of CARVYKTI, its BCMA-directed CAR T-cell therapy for multiple myeloma developed, manufactured and co-promoted with Johnson & Johnson.

Chief Executive Officer Ying Huang said Legend is the “world’s largest standalone cell therapy company” and described CARVYKTI as the “fastest commercial launch among all CAR T therapies to date.” Huang said the product generated nearly $2 billion in total sales in 2025 and has treated more than 10,000 patients to date. She also said Legend had $835 million in cash and liquidity at the end of the first quarter and expects to achieve corporate profitability this year on an adjusted net income basis.

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Why Legend Biotech Stock Is Having Its Best Month YetThe event focused on CARVYKTI’s long-term efficacy, the case for earlier use in multiple myeloma and evolving safety management practices. Huang said the company views CARVYKTI as a one-time infusion that can be used in inpatient or outpatient settings and may offer lifetime cost savings for patients, healthcare practitioners and payers.

Physicians Highlight Long-Term Data and “Curative Potential” Dr. Binod Dhakal, associate professor of medicine at the Medical College of Wisconsin, said CARVYKTI has changed how physicians discuss multiple myeloma, historically considered an incurable cancer.

Dhakal pointed to a proposed International Myeloma Working Group definition of cure in multiple myeloma, which includes sustained treatment-free minimal residual disease, or MRD, negativity for five years, sustained complete response, repeated MRD assessments and no evidence of disease by imaging.

Discussing long-term CARTITUDE-1 follow-up, Dhakal said that among 97 treated patients, about one-third were treatment-free and progression-free for more than five years after a single infusion. He also said 12 patients at one center with annual MRD and PET assessments were MRD negative and PET negative for five years, meeting the proposed definition of cure.

Dhakal said median overall survival in CARTITUDE-1 was about 61 months in a heavily pretreated population with a median of six prior lines of therapy. He contrasted that with historical expectations for similar triple-class exposed patients, saying they would have had median overall survival of less than a year.

Doctors Say Earlier CAR T Use May Improve Outcomes Dr. Doris Hansen, assistant member of blood and marrow transplant and cellular immunotherapy at Moffitt Cancer Center, argued that earlier treatment with CARVYKTI is preferable because multiple myeloma becomes more difficult to treat and more genomically complex with each line of therapy.

Hansen said patients are lost at each treatment line, with attrition rates between 10% and 30% per line of therapy. She cited CARTITUDE-1 and CARTITUDE-4 data, including median progression-free survival of about three years in heavily pretreated CARTITUDE-1 patients and median progression-free survival as high as 50 months in certain triple-class exposed patients with three prior lines of therapy. In CARTITUDE-4, she said median progression-free survival had not been reached at 30 months in patients who were proteasome inhibitor and IMiD exposed and lenalidomide refractory.

Hansen also said safety appears to improve when CARVYKTI is used earlier. She noted that Parkinsonism was reported in 6% of patients in CARTITUDE-1 at five years, while CARTITUDE-4 had one patient with Parkinsonian features, or less than 1%. She added that manufacturing success was 99% when CAR T was moved earlier in the disease course.

In the question-and-answer session, Hansen said she is treating all eligible patients in second line with CARVYKTI, whether they are functional high risk or standard risk, unless logistical or comorbidity issues prevent it. Dhakal and Dr. Surbhi Sidana, associate professor of medicine at Stanford University, described similar practice patterns, saying they recommend CAR T as early as first relapse for eligible patients.

Bridging Therapy Emphasized as Safety Strategy Sidana focused on safety management and said disease burden before CARVYKTI treatment is an important factor. She said patients who did not respond well to bridging therapy had worse progression-free survival and overall survival, and that going into CARVYKTI with high disease burden is “not a good idea.”

Sidana cited multiple data sets, including CARTITUDE-4 and real-world consortium data, to argue that CARVYKTI should be used as a consolidative therapy after effective disease debulking. In a U.S. Multiple Myeloma CAR T Consortium data set of more than 750 patients, she said 21 of 22 Parkinsonism cases occurred in patients who had not responded to bridging therapy. She said the risk of Parkinsonism was 5% in non-responders compared with 0.5% in patients with a partial response or better to bridging therapy.

Sidana said manufacturing constraints are “a non-issue” at this point and that bridging options depend on the patient’s prior treatments and refractory status. She said talquetamab is often used in more refractory patients, while earlier-line patients may receive other options such as daratumumab-based bridging if appropriate.

CAR T Versus Bispecifics and Future Treatment Settings The panel also discussed sequencing CARVYKTI with bispecific antibodies. Dhakal said that for eligible patients, his preference is to offer CAR T first, citing CARVYKTI’s potential curative option, one-time treatment and quality-of-life considerations. Hansen said Immunotherapy Working Group guidance recommends CAR before bispecific therapy for eligible patients.

A company representative also discussed two real-world data sets, including a German registry of 606 patients and a U.S. TriNetX analysis of 389 patients. The representative said both supported the idea that earlier CARVYKTI use and CAR T before bispecific therapy were associated with better outcomes, while cautioning that the TriNetX analysis was not randomized and could not perfectly match patient characteristics.

Panelists said they are awaiting data from ongoing frontline studies, including CARTITUDE-5 in transplant-ineligible or transplant-delayed patients and CARTITUDE-6 comparing CARVYKTI head-to-head against transplant in transplant-eligible patients. Sidana said the field is moving toward using the most effective therapies earlier, but added that physicians need to wait for the data.

Asked about in vivo CAR T approaches, Hansen, Sidana and Dhakal described the technology as exciting but early. Hansen said there is limited follow-up and more information is needed on safety and durability. Huang declined to provide details on Legend’s own in vivo program ahead of a medical meeting abstract publication.

Legend also said demand is shifting earlier. A company representative said that, on the most recent earnings call, the company reported 41% of CARVYKTI patients were coming from second and third line treatment settings. The representative said Legend is expanding education, treatment-center access and patient activation efforts, including targeted direct-to-consumer advertising and outreach through social media.

About Legend Biotech NASDAQ: LEGNLegend Biotech NASDAQ: LEGN is a commercial-stage biopharmaceutical company specializing in the development and commercialization of chimeric antigen receptor T-cell (CAR-T) therapies for oncology. Headquartered in Somerset, New Jersey, with research and development operations in Shanghai, the company leverages a global infrastructure to advance innovative cellular therapies. Legend Biotech pursues a strategy of strategic collaboration to extend its reach, most notably through its partnership with Janssen Biotech, a subsidiary of Johnson & Johnson.

The company's lead asset, ciltacabtagene autoleucel (commercially marketed as Carvykti), is a B-cell maturation antigen (BCMA)–directed CAR-T therapy for the treatment of relapsed or refractory multiple myeloma.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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LB2102 demonstrated a manageable safety profile and encouraging clinical activity in solid tumors among heavily pretreated patients Responses observed at higher dose levels of LB2102 with an ORR of 28.6% and a DCR of 78.6%, with durable responses seen in some patients New CARVYKTI® data continue to support durable efficacy and a consistent safety profile in multiple myeloma
BRIDGEWATER, N.J., June 01, 2026 (GLOBE NEWSWIRE) --  Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech or the Company), a global leader in cell therapy, today announced first-in-human clinical data for LB2102, its investigational DLL3-targeted CAR-T cell therapy for patients with relapsed or refractory small cell lung cancer (SCLC) or large-cell neuroendocrine carcinoma (LCNEC). The data demonstrate early evidence of clinical activity and a manageable safety profile. At higher dose levels, an objective response rate (ORR) of 28.6% and disease control rate (DCR) of 78.6% were observed, including durable responses in some heavily pretreated patients.

The data, presented in a rapid oral presentation (Abstract #8012) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, support the clinical potential of CAR-T cell therapy in solid tumors.

Additionally, new analyses from the CARTITUDE program were presented, further highlighting sustained clinical benefit and a consistent safety profile for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) in multiple myeloma.

“The data presented at ASCO underscores the progress of our next-generation pipeline and the meaningful impact that CARVYKTI continues to deliver to patients,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “LB2102 marks an early step in expanding CAR-T cell therapy into solid tumors, addressing the unique challenges where current treatment options are limited and early data show promising clinical activity in difficult-to-treat cancers. At the same time, CARVYKTI continues to demonstrate durable efficacy and a consistent safety profile, reinforcing its role as a transformative therapy for multiple myeloma and supporting our leadership in cell therapy.”

LB2102: Early Evidence of Clinical Activity Observed in Solid Tumors

Early Phase 1 results from the ongoing study of LB2102 demonstrate encouraging anti-tumor activity and a manageable safety profile in patients with relapsed or refractory (R/R) SCLC or LCNEC, a population characterized by advanced disease and limited treatment options.

LB2102 is an investigational DLL3-targeted autologous CAR-T cell therapy with dnTGFBR2 Armor engineered to enhance activity by overcoming immunosuppressive signaling within the tumor microenvironment.

Efficacy Results

Objective response rate (ORR): 20% (4/20)Disease control rate (DCR): 70% (14/20)At dose level ≥3: ORR: 28.6%DCR: 78.6%Median duration of disease control: 6.1 months Median duration of response: 6.5 monthsOngoing responses were observed in 2 patients at data cutoff Safety Results

No dose-limiting toxicities or treatment-related deathsCytokine release syndrome (CRS) occurred in 30% of patients (all Grade ≤2)Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 15% of patients (two Grade 1 and one Grade 3)Most Grade ≥3 adverse events were hematologic and co-attributed to lymphodepletion “Patients with relapsed or refractory SCLC or LCNEC have historically had very limited treatment options and poor outcomes,” said Zhonglin Hao, M.D., Ph.D., Professor of Medicine and Cancer Biology, Director, Thoracic Oncology Program, University of Kentucky Markey Cancer Center. “Durable disease control and responses at higher dose levels with LB2102 are encouraging, particularly alongside a manageable safety profile. These findings support continued evaluation of CAR-T approaches in solid tumors, where effective therapies remain limited.”‡

LB2102 represents part of the Company’s broader strategy to expand CAR-T therapies beyond hematologic malignancies and into solid tumors. In November 2023, Legend Biotech’s subsidiary, Legend Biotech Ireland Limited, entered into a license agreement with Novartis Pharma AG (the Novartis Agreement), granting Novartis an exclusive worldwide license to develop, manufacture, and commercialize certain Legend Biotech CAR-T cell therapies targeting DLL3.

Under the Novartis Agreement, Legend Biotech is responsible for conducting the current Phase 1 clinical trial of LB2102 in the United States, while Novartis is responsible for conducting all other development, manufacturing, and commercialization for the licensed products, including LB2102.

CARVYKTI®: Ongoing Clinical Data in Multiple Myeloma

New analyses from the CARTITUDE program continue to demonstrate sustained clinical benefit and consistent safety profile of CARVYKTI® in patients with multiple myeloma.

In the CARTITUDE-4 subgroup analysis (Abstract #7536), progression-free survival and overall survival benefits were observed across both high-risk and standard-risk cytogenetic populations among patients who responded to bridging therapy, with 30-month OS rates greaterthan 85%.No cases of immune effector cell (IEC)–associated Parkinsonism were reported.

In a separate multi-study analysis (Abstract #7533), a low incidence (1.2%) of IEC-associated enterocolitis (IEC-EC) was observed, further characterizing this uncommon adverse event and reinforcing the overall favorable benefit-risk profile of CARVYKTI®.

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 18 countries and has been used to treat more than 10,000 patients to date.

CARVYKTI® IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED and RECURRENT CYTOPENIA, and SECONDARY HEMATOLOGICAL MALIGNANCIESCytokine 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 ≤2 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 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.ii 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.iii 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.iv

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.v

ABOUT LB2102
NCT05680922 is a Phase 1, first-in-human, open-label, multicenter, dose escalation and expansion study of DLL3-targeted chimeric antigen receptor T-cells (LB2102) in patients with extensive stage small cell lung cancer or large cell neuroendocrine lung cancer.vi

ABOUT SMALL-CELL LUNG CANCER
Lung cancer is a leading cause of cancer deaths, contributing to 25 percent of all cancer-related fatalities annually in the United States.vii Small cell lung cancer (SCLC) is the most aggressive, and accounts for roughly 10-15 percent of lung cancer cases in the United States.viii,ix An estimated 30,000 to 35,000 people are newly diagnosed with the disease each year. This cancer becomes more difficult to treat once it has spread and becomes extensive stage SCLC. Approximately 60 to 70 percent of SCLC patients are diagnosed with metastatic SCLC.,x

ABOUT LEGEND BIOTECH
With over 3,000 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. Legend Biotech 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. Centered in the United States, Legend Biotech 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, Legend Biotech plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.

Learn more at https://legendbiotech.com and follow us on X, Instagram, 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; the benefits of CARVYKTI, including its emerging curative potential; and the potential of LB2102, including the reproducibility and durability of any favorable results initially seen in patients dosed to date in clinical trials. 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 10, 2026. 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.

‡ Zhonglin Hao, M.D., Ph.D., Professor of Medicine and Cancer Biology, Director, Thoracic Oncology Program, University of Kentucky Markey Cancer Center, has provided consulting and advisory services to Legend Biotech; he has not been paid for any media work.

INVESTOR CONTACT:
Jessie Yeung
Tel: (732) 956-8271
[email protected]

PRESS CONTACT:
Kim Fox
Tel: (848) 388-8445
[email protected]

i CARVYKTI™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.
ii 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.
iii 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.
iv 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.
v 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.
vi ClinicalTrials.gov. DLL3-Directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage Small Cell Lung Cancer. Available at: https://www.clinicaltrials.gov/study/NCT05680922. Accessed May 2025
vii American Cancer Society. “Key Statistics for Lung Cancer.” https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html. Accessed November 2022.
viii Byers LA, Rudin CM. Small cell lung cancer: where do we go from here? Cancer. 2015;121(5):664-72.
ix Rare Diseases. “Rare Disease Database.” https://rarediseases.org/rare-diseases/small-cell-lung-cancer. Accessed November 2022.
x Gong J, Salgia R. Managing patients with relapsed small-cell lung cancer. J Oncol Pract. 2018;14(6):359-66.

Testing tubes full of blood are seen in Washington, U.S., February 16, 2016. REUTERS/Gary Cameron Purchase Licensing Rights, opens new tab

June 2 (Reuters) - Legend Biotech's (LEGN.O), opens new tab experimental therapy showed early signs that its approach of generating disease-fighting ​cells within patients may work for a type of blood cancer, sending ‌shares of the company up nearly 30%.

Unlike traditional CAR‑T therapies that require extracting, modifying and reinfusing a patient's immune cells, Legend aims to generate them inside the body ​using its in vivo dual-targeting therapy, LB2501.

Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here.

In the highly anticipated ​early-stage trial data reported on Tuesday, 12 patients with relapsed/refractory B-cell non-Hodgkin ⁠lymphoma were treated across two dose levels as of April 1.

In ​the higher-dose cohort, the preliminary data showed all six patients responded, while five ​had a complete response.

The data points "to a potentially best-in-class profile in the in vivo CAR-T space and best-in-disease profile in NHL," Oppenheimer analyst Kostas Biliouris said, adding that ​it strengthened chances of Legend's acquisition.

Several pharmaceutical companies including AstraZeneca (AZN.L), opens new tab and Eli ​Lilly (LLY.N), opens new tab have recently struck deals in the in vivo CAR-T field.

LB2501 is designed to ‌generate ⁠CAR-T cells directly within the patient through a single, direct infusion, eliminating the need for ex vivo cell engineering and manufacturing.

"By generating CAR-T cells directly within the patient, this approach has the potential to simplify treatment delivery ​and expand access ​for patients who ⁠may not be able to receive traditional CAR-T cell therapies," said CEO Ying Huang.

While a longer follow-up was warranted, the data ​highlights the potential of LB2501 as a scalable, readily ​accessible "off-the-shelf" immunotherapy ⁠for B-cell malignancies, Legend said.

It did not provide additional dose-level details and said further data would be shared at a medical meeting later this month.

The company said no ⁠dose-limiting ​toxicities, serious adverse events or fatal cases were ​reported. Infusion-related reactions occurred in nine patients, but were resolved within a two-day median, it ​said.

Reporting by Sriparna Roy and Mariam Sunny in Bengaluru; Editing by Pooja Desai

Our Standards: The Thomson Reuters Trust Principles., opens new tab