Legend Biotech updates CARVYKTI cell pipeline

Legend Biotech outlines progress across CARVYKTI and a broad set of early-stage autologous, allogeneic and in vivo cell therapy programs.

Rhea-AI Filing Summary

Legend Biotech Corporation (LEGN) reports an updated clinical pipeline focused on cell therapies across oncology and autoimmune diseases. The update highlights CARVYKTI, a BCMA-directed autologous therapy developed in collaboration with Janssen, which is listed under NDA status with multiple front-line newly diagnosed multiple myeloma trials (CARTITUDE-5, -6 and -10) in patient follow-up or enrolling. Additional autologous programs include LB1908 for relapsed/refractory gastric and pancreatic cancers and LB2102 for second-line and later small cell lung cancer and large cell neuroendocrine carcinoma, each having met primary endpoints and in patient follow-up. The pipeline also details early-stage autologous, allogeneic and in vivo candidates such as LB2401–LB2406, LB2501, LB2503 and LB2505 for multiple myeloma, B-cell non-Hodgkin lymphoma and autoimmune indications, with several investigator-initiated trials in China and multiple U.S. INDs cleared by the FDA.

Filing Explained

The September 14 update adds pipeline information to specified registration statements while programs remain at mixed development stages and approval is unresolved.

As a Form 6-K, this is an interim report furnishing material information published by a foreign private issuer. On September 14, 2026, Legend Biotech disclosed an updated clinical pipeline and stated that the report and exhibit are incorporated by reference into specified Form F-3 and Form S-8 registration statements.

The pipeline table places programs across NDA, Phase III, Phase II, Phase I, preclinical, enrolling, initiating, and patient-follow-up statuses. The filing also states that the safety and efficacy of the agents and uses under investigation have not been established, with no assurance of health-authority approval or commercial availability.

The table additionally lists LB2502 as an autologous therapy for relapsed or refractory multiple myeloma that is enrolling in a Phase I trial. Thus, the filing updates the documented pipeline and registration-statement materials, but leaves the programs' approval and commercialization outcomes unresolved.

Key Terms

New Drug Application, autologous therapies, allogeneic therapies, Investigational New Drug (IND), +1 more

5 terms

New Drug Application regulatory

"Partner Current Status NDA Phase III Phase II Phase I Pre - Clinical"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

autologous therapies medical

"CARVYKTI®: BCMA - directed Autologous Therapy Patient follow - up"

allogeneic therapies medical

"Allogeneic Therapies Enrolling Relapsed/Refractory Autoimmune Diseases"

Investigational New Drug (IND) regulatory

"IND applications have been cleared by the United States FDA"

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

CAR-NK medical

"CD19 x BCMA (CAR - NK) LB2405 Enrolling"

CAR‑NK are immune cells (natural killer cells) that have been genetically given a chimeric antigen receptor so they can home in on and destroy specific diseased cells, typically cancer. Think of it like equipping a guard with GPS coordinates for a target: it makes the cell better at finding and killing the enemy. Investors watch CAR‑NK programs because they offer potential for powerful, off‑the‑shelf therapies with different safety and manufacturing profiles than traditional drugs, which can drive company value but also carry clinical and regulatory risk.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What does Legend Biotech (LEGN) disclose in its latest Form 6-K?

Legend Biotech provides an updated clinical pipeline, highlighting CARVYKTI’s NDA status, multiple front-line multiple myeloma trials, and a range of autologous, allogeneic and in vivo cell therapy programs in various stages from pre-clinical through Phase III across oncology and autoimmune diseases.

What is the status of CARVYKTI in Legend Biotech’s (LEGN) pipeline update?

CARVYKTI, a BCMA-directed autologous therapy developed with Janssen, is listed under NDA with several newly diagnosed multiple myeloma trials (CARTITUDE-5, CARTITUDE-6, CARTITUDE-10) reported as in patient follow-up or enrolling in front-line treatment settings.

Which Legend Biotech (LEGN) programs have met primary endpoints?

The pipeline shows that LB1908 for relapsed/refractory gastric and pancreatic cancers and LB2102 for second-line and later small cell lung cancer and large cell neuroendocrine carcinoma have met primary endpoints and are in patient follow-up.

What early-stage autologous therapies does Legend Biotech (LEGN) highlight?

Legend Biotech lists early-stage autologous therapies including LB2401, LB2402, LB2403 and LB2502 for relapsed/refractory multiple myeloma, with targets such as GPRC5D, CD19 x GPRC5D, GPRC5D (FAST CAR) and FcRH5 (FAST CAR), generally noted as in patient follow-up or enrolling.

What allogeneic and in vivo therapies are in Legend Biotech’s (LEGN) pipeline?

Allogeneic programs include LB2404D, LB2405, LB2302, LB2303 and LB2406 for autoimmune diseases and B-cell non-Hodgkin lymphoma, described as enrolling. In vivo programs LB2501, LB2503 and LB2505 target B-cell non-Hodgkin lymphoma and multiple myeloma, with trials enrolling or initiating.

Which regulatory milestones are mentioned in Legend Biotech’s (LEGN) pipeline update?

The update notes that CARVYKTI is under NDA, several trials are multi-regional clinical trials, and certain programs have IND applications cleared by the U.S. FDA. Some trials are characterized as investigator-initiated in China under local clinical development.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 09/14/2026 - 08:00 AM Accepted by SEC EDGAR 09/14/2026 - 08:00 AM Learn about SEC filing dates

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

of the Securities Exchange Act of 1934

Date of Report: September 14, 2026

Commission File Number: 001-39307

Legend Biotech Corporation

(Exact Name of Registrant as Specified in its Charter)

77 Corporate Drive

Bridgewater, New Jersey 08807

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

Form 20-F  ☒            Form 40-F  ☐

Legend Biotech Updates Clinical Pipeline

On September 14, 2026, Legend Biotech Corporation (the “Company”) made an updated clinical pipeline available on its website, as set forth in Exhibit 99.1 to this Form 6-K.

This report on Form 6-K, including the exhibits attached hereto, shall be deemed to be incorporated by reference in the registration statements of the Company on Form F-3 (Nos. 333-278050 and 333-257625) and Form S-8 (Nos. 333-239478 and 333-283217), to the extent not superseded by documents or reports subsequently filed.

EXHIBIT INDEX

Exhibit		Title
99.1		Pipeline

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

		LEGEND BIOTECH CORPORATION (Registrant)
September 14, 2026		By:		/s/ Alan Bash
				Alan Bash
				Interim Chief Executive Officer

Exhibit 99.1

Advancing a Robust, Differentiated Cell Therapy Pipeline 1 Notes ： 1. In collaboration with Janssen, Pharmaceutical Companies of Johnson & Johnson. NDMM = Newly Diagnosed Multiple Myeloma. 2. Phase 1 investigator - initiated trial in China 3. IND applications have been cleared by the United States FDA 4. Subject to an exclusive license agreement with Novartis Pharma AG. The safety and efficacy of the agents and/or uses under in ves tigation have not been established. There is no assurance that the agents will receive health authority approval or become commercially available in any country for the uses being investigated. Additionally, as some programs are still confidential, ce rtain candidates may not be included in this list 5. Subject to the terms of Legend Biotech’s collaboration and license agreement with Johnson & Johnson Partner Current Status NDA Phase III Phase II Phase I Pre - Clinical Indication Target Program CARVYKTI®: BCMA - directed Autologous Therapy Patient follow - up NDMM (Front - line) (Transplant Not Intended) (CARTITUDE - 5) (1) BCMA CARVYKTI® Patient follow - up NDMM ( Front - line, Transplant Eligible) (CARTITUDE - 6) (1) Enrolling NDMM ( Front - line, Transplant Not Intended) (CARTITUDE - 10) (1) Autologous Therapies Met primary endpoint, patient follow - up Relapsed/Refractory Gastric & Pancreatic Cancers (3) Claudin 18.2 LB1908 NOVARTIS Met primary endpoint, patient follow - up 2L+ Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma (3)(4) DLL3 LB2102 Patient follow - up Relapsed/Refractory Multiple Myeloma (2) GPRC5D LB2401 Patient follow - up Relapsed/Refractory Multiple Myeloma (2) CD19 x GPRC5D LB2402 Patient follow - up Relapsed/Refractory Multiple Myeloma (2) GPRC5D (FAST CAR) LB2403 Enrolling Relapsed/Refractory Multiple Myeloma (2) FcRH5 (FAST CAR) LB2502 Allogeneic Therapies Enrolling Relapsed/Refractory Autoimmune Diseases (2) CD19 x CD70 (CAR - γδ T) LB2404D Enrolling Relapsed/Refractory Autoimmune Diseases (2) CD19 x BCMA (CAR - NK) LB2405 Enrolling Relapsed/Refractory B - cell Non - Hodgkin Lymphoma (2) CD20 (CAR - αβ T) LB2302 Enrolling Relapsed/Refractory B - cell Non - Hodgkin Lymphoma (2) CD19 x CD20 (CAR - γδ T) LB2303 Enrolling Relapsed/Refractory B - cell Non - Hodgkin Lymphoma (2) CD19 x CD20 (CAR - γδ T) LB2406 In Vivo Therapies Enrolling Relapsed/Refractory B - cell Non - Hodgkin Lymphoma (2) CD19 x CD20 LB2501 Enrolling Relapsed/Refractory Multiple Myeloma (2) GPRC5D LB2503 Initiating Relapsed/Refractory Multiple Myeloma (2)(5) BCMA LB2505 Multi - Regional Clinical Trial Multi - Regional Clinical Trial US IND US IND Multi - Regional Single Arm Trial

Filing Exhibits & Attachments

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• EX-99.1 EXHIBIT 99.1 3.3 KB