Welcome to our dedicated page for Legend Biotech SEC filings (Ticker: LEGN), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Legend Biotech Corporation (NASDAQ: LEGN) SEC filings page on Stock Titan provides direct access to the company’s regulatory disclosures as a foreign private issuer. Legend Biotech files annual reports on Form 20‑F and frequent current reports on Form 6‑K, which together outline its financial performance, cell therapy pipeline, and key business developments.
In these filings, Legend Biotech presents unaudited interim condensed consolidated financial statements, including statements of profit or loss, financial position, changes in equity, and cash flows. Investors can review details on license revenue, collaboration revenue related to CARVYKTI® (ciltacabtagene autoleucel; cilta‑cel), research and development expenses, selling and distribution expenses, and collaboration funding arrangements. Management’s Discussion and Analysis (MD&A), often attached as exhibits to Form 6‑K, provides narrative context around revenue drivers, cost trends, and liquidity.
Filings also capture clinical and regulatory milestones. Recent 6‑Ks incorporate press releases on CARTITUDE‑1, CARTITUDE‑4, and CARTITUDE‑6 study updates, FDA and European Commission label changes for CARVYKTI, and early data from programs such as LUCAR‑G39D, LB2102, and LB1908. Additional 6‑Ks describe agreements with Janssen for component and product supply, preliminary sales figures for CARVYKTI, and participation in major scientific and investor conferences.
Stock Titan enhances these documents with AI-powered summaries that highlight the main points of lengthy 6‑K and 20‑F filings, helping users quickly identify information on revenue composition, cell therapy pipeline status, collaboration structures, and risk disclosures. Real‑time ingestion of EDGAR updates ensures that new Legend Biotech filings, including any Form 6‑K related to financial results or material agreements, appear promptly.
Users can also monitor equity and compensation-related disclosures via Legend Biotech’s registration statements on Form S‑8, as referenced in its 6‑K reports, and review how these interact with share‑based compensation expenses reported in the financial statements. While Legend Biotech does not file Forms 3, 4, and 5 as a U.S. domestic issuer would, this page centralizes its available SEC reporting so investors can follow the company’s development as a global cell therapy business.
Legend Biotech Corporation reported several board changes effective January 20, 2026. The company appointed Robin Meng, chairman and executive director of GenScript, as a Class III director with a term running until the 2026 annual general meeting of shareholders. GenScript is Legend Biotech’s largest shareholder and the companies are party to related-party agreements previously described in Legend Biotech’s Form 20-F for the year ended December 31, 2024.
Two directors, Dr. Li Zhu and Yau Wai Man Philip, resigned from the Board, and each resignation was stated not to result from any dispute or disagreement over Legend Biotech’s operations, policies, or practices. In recognition of Mr. Yau’s service, the Compensation Committee approved accelerated vesting of his unvested restricted share units and a one-time cash payment of $56,250, equal to his remaining 2026 board compensation. Following his resignation, Tomas Heyman was appointed chair of the Audit Committee.
Legend Biotech Corporation reported preliminary net trade sales for its CAR-T therapy CARVYKTI®, with approximately
The company noted that the final amount of revenue and gross profit to be recorded in its consolidated financial statements will be determined as management completes the financial statements for the period. The data has not been audited, reviewed, or otherwise examined by Legend Biotech’s independent registered public accountants, and they have not expressed any assurance regarding these figures. The company also cautioned that forward-looking statements about CARVYKTI® sales and resulting gross profit are subject to numerous risks and uncertainties, including product development, regulatory actions, partner performance, intellectual property challenges, competition, and pricing pressures.
Legend Biotech presents an updated corporate overview focused on its CAR-T therapy CARVYKTI and a path to profitability. The company reports approximately $1B in cash, cash equivalents and time deposits as of September 30, 2025, and about $1.7B in last-twelve-month CARVYKTI net trade sales through Q3 2025. Operating margin has improved from -142% in Q2 2023 to -16% in Q3 2025, and Legend Biotech expects to achieve company-wide operating profit, excluding unrealized foreign exchange losses, in 2026.
CARVYKTI is described as the top-selling CAR-T therapy in a single quarter, with an estimated peak annual sales potential of over $5B, more than 10,000 patients treated worldwide and 10,000 annualized dose capacity expected in 2026. Legend Biotech highlights a 2,900+ person global team, multiple global manufacturing sites, and a 50/50 cost-sharing and profit-split collaboration with Johnson & Johnson (30/70 in Greater China). The presentation also outlines a diversified cell therapy pipeline, an in vivo CAR-T platform entering clinical proof-of-concept, and 2026 priorities to maximize CARVYKTI market leadership, advance innovation, and drive profitability.
Legend Biotech reported recent business progress and outlined strategic priorities for 2026, centered on maximizing the market leadership of its multiple myeloma cell therapy CARVYKTI® and advancing its broader cell therapy pipeline.
The company highlighted that the latest NCCN guidelines recommend talquetamab as a bridging therapy before CAR-T treatment in relapsed or refractory multiple myeloma, which can help keep patients eligible for CARVYKTI® and improve outcomes, particularly in aggressive disease. Legend Biotech also completed enrollment in August 2025 for its Phase 3 CARTITUDE-6 registrational trial in newly diagnosed, transplant-eligible multiple myeloma patients.
Legend Biotech reiterated forward-looking goals, including expected market expansion and order volume for CARVYKTI® and LUCAR-G39D, and stated that it expects to be able to fund operations into 2026, to reach company-wide profitability in 2026, and to achieve Carvykti-related profitability by the end of 2025, while emphasizing the usual clinical, regulatory and commercial risks.
Legend Biotech Corporation reported new clinical data on its CAR-T therapies presented at the 67th American Society of Hematology Annual Meeting in Orlando, Florida. Results from the CARTITUDE-1 and CARTITUDE-4 studies showed that a single infusion of CARVYKTI (ciltacabtagene autoleucel) provided long-term progression free survival benefit for patients with standard-risk relapsed or refractory multiple myeloma. The company also reported that earlier use of CARVYKTI in CARTITUDE-4 was associated with better immune fitness and stronger immune effects.
Beyond multiple myeloma, Legend Biotech highlighted early Phase 1 data for LUCAR-G39D in adults with relapsed or refractory B-cell non-Hodgkin lymphoma. In this ongoing study, LUCAR-G39D showed a manageable safety profile and encouraging antitumor activity, suggesting potential for further development within the company’s novel CAR-T platform.
Legend Biotech (LEGN) reported sharply higher revenue and narrower losses for Q3 2025. Total revenue reached $272.3 million, driven by collaboration revenue of $261.8 million tied to CARVYKTI sales. Operating loss improved to $43.5 million from $70.4 million, and net loss narrowed to $39.7 million from $125.3 million.
For the nine months ended September 30, revenue rose to $722.5 million from $440.7 million as CARVYKTI commercialization scaled. Year‑to‑date results were weighed by $162.4 million of other expense primarily from unrealized foreign exchange losses on USD/EUR balances. Adjusted net loss for the nine months was $35.7 million.
Cash and cash equivalents were $278.9 million and time deposits were $713.7 million (about $1.0 billion combined) as of September 30, 2025. The company noted CARVYKTI net trade sales of approximately $524 million, over 9,000 patients treated to date, and the start of commercial production at its Tech Lane site in Belgium. Collaboration interest‑bearing advanced funding totaled $314.8 million, with $142.9 million estimated to be recouped by Janssen within twelve months.
Legend Biotech (LEGN) announced upcoming clinical data visibility at ASH 2025. The company will deliver 10 presentations at the 67th American Society of Hematology Annual Meeting, held December 6–9, 2025 in Orlando, FL. The slate includes two oral presentations and seven posters on CARVYKTI (ciltacabtagene autoleucel) for multiple myeloma, plus one oral presentation on Lucar-G39D, an investigational anti-CD20/CD19 dual-CAR allogeneic gamma delta T cell therapy in relapsed or refractory B-cell non-Hodgkin lymphoma.
The report is incorporated by reference into Legend Biotech’s Form F-3 and Form S-8 registration statements.
Legend Biotech (LEGN) announced U.S. FDA approval of a CARVYKTI label update to include overall survival (OS) results from the Phase 3 CARTITUDE-4 study. The update states CARVYKTI showed a statistically significant OS improvement versus standard of care in relapsed/refractory multiple myeloma after one to three prior lines of therapy. At a median follow-up of 33.6 months, neither treatment arm reached median OS, indicating durable survival has not yet been fully characterized.
The label also adds immune effector cell‑associated enterocolitis (IEC‑EC) to the Boxed Warnings and Warnings and Precautions, noting cases with severe or prolonged diarrhea, abdominal pain, weight loss, and rare fatalities from perforation or sepsis. Additionally, John Cunningham (JC) virus reactivation leading to progressive multifocal leukoencephalopathy (PML) was added to Warnings and Precautions (Infections) and Postmarketing Experience, including fatal cases. Physicians are advised to follow institutional guidelines for IEC‑EC management and conduct appropriate diagnostic evaluations for neurological events.
Legend Biotech (LEGN) reported preliminary CARVYKTI sales of approximately $524 million in net trade sales for the quarter ended September 30, 2025. The figure was provided by collaboration partner Janssen under their existing agreement.
Legend Biotech noted it has not independently verified this sales number. The final determination of revenue and gross profit for this period will be made upon completion of its financial statements, and the company’s independent auditors have not audited or reviewed the data. The filing also includes forward‑looking statements language regarding expectations for CARVYKTI sales and profitability.
Legend Biotech Corporation, through its wholly owned subsidiary Legend Biotech USA Inc., has entered into a new Component and Product Supply Agreement with Janssen Pharmaceuticals, Inc. covering the manufacture and supply of ciltacabtagene autoleucel (cilta‑cel) for clinical and commercial use worldwide, excluding Greater China. The product will be manufactured at the existing GMP facility in Raritan, New Jersey that both parties already use, and this agreement replaces a prior interim supply arrangement signed in 2022.
The agreement will take effect after agreed transition steps are completed, including several quality and services agreements and any required health authority approvals, and it will end automatically if the broader collaboration and license agreement between the parties expires or is terminated. Janssen will pay Legend a transfer price for the product based on total production costs plus a markup, while the ultimate commercial and clinical supply costs will be shared equally under the existing collaboration framework. Janssen will also provide key raw materials to Legend at its own cost plus a markup, under customary commercial, quality, intellectual property, and indemnification terms.
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