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Legend Biotech gets FDA IND clearance for dual-targeting CAR-T therapy

Thu, 15 Oct 2026 08:05:11 -0400

Legend Biotech Corporation (NASDAQ: LEGN) announced that the U.S. Food and Drug Administration has cleared an investigational new drug application for LB2501, an in vivo CAR-T therapy targeting both CD19 and CD20 antigens for the treatment of relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin lymphoma.

LB2501 is designed as an off-the-shelf, single-infusion therapy that generates CAR-T cells directly within the patient, without the manufacturing steps required for conventional autologous CAR-T therapies. The company claims it is the first dual-targeting in vivo CAR-T therapy to receive FDA IND clearance.

The therapy is built on Legend Biotech's proprietary TaVec platform, which uses an

Legend Biotech gets FDA IND clearance for dual-targeting CAR-T therapy

Thu, 15 Oct 2026 08:05:11 -0400

The therapy is built on Legend Biotech's proprietary TaVec platform, which uses an

Legend Biotech Announces U.S. FDA Clearance of IND Application for LB2501, an Investigational CD19/CD20 In Vivo CAR-T Therapy

Thu, 15 Oct 2026 08:00:00 -0400

LB2501 is an off-the-shelf in vivo CAR-T therapy designed to generate dual-targeting CD19/CD20 CAR-T cells directly within the patient after a single infusion, making it the first known dual-targeting in vivo CAR-T therapy to receive FDA IND clearance
IND clearance supports planned U.S. Phase 1/2 study and advances Legend Biotech’s in vivo cell engineering platform

BRIDGEWATER, N.J., Oct. 15, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new

Legend Biotech Announces U.S. FDA Clearance of IND Application for LB2501, an Investigational CD19/CD20 In Vivo CAR-T Therapy

Thu, 15 Oct 2026 08:00:00 -0400

LB2501 is an off-the-shelf in vivo CAR-T therapy designed to generate dual-targeting CD19/CD20 CAR-T cells directly within the patient after a single infusion, making it the first known dual-targeting in vivo CAR-T therapy to receive FDA IND clearance
IND clearance supports planned U.S. Phase 1/2 study and advances Legend Biotech’s in vivo cell engineering platform

Form 6-K Legend Biotech Corp For: Oct 15

Thu, 15 Oct 2026 08:00:00 -0400

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H.C. Wainwright Reiterates Buy Rating on Legend Biotech Corp. (LEGN)

Thu, 15 Oct 2026 07:09:59 -0400

H.C. Wainwright analyst Mitchell S. Kapoor reiterated a Buy rating and $65.00 price target on Legend Biotech Corp. (NASDAQ: LEGN).

The analyst commented: "Johnson & Johnson reported 3Q26 CARVYKTI net trade sales (NTS) of $710M vs. $657M Q/Q (+8%), above our expectations and ~3% ahead of the $691M consensus average ($690M median) in Legend’s October 2 broker survey. FactSet forecasts show CARVYKTI growing to ~$3.4B in 2027 from ~$2.7B in 2026, alongside just $130M for Gilead's (GILD; not rated) anito-cel following launch in late 2026. By 2030, the Street now expects CARVYKTI to approach $4.9B even as anito-cel becomes a ~$1.5B

Form 6-K Legend Biotech Corp For: Oct 13

Tue, 13 Oct 2026 07:30:00 -0400

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Legend Biotech Corp. (LEGN) PT Lowered to $68 at Barclays

Tue, 13 Oct 2026 03:35:50 -0400

Barclays analyst Gena Wang lowered the price target on Legend Biotech Corp. (NASDAQ: LEGN) to $68.00 (from $74.00) while maintaining a Overweight rating.

Legend Biotech Corp. (LEGN) PT Lowered to $33 at JPMorgan

Fri, 09 Oct 2026 08:11:03 -0400

JPMorgan analyst Jessica Fye lowered the price target on Legend Biotech Corp. (NASDAQ: LEGN) to $33.00 (from $35.00) while maintaining a Neutral rating.

Legend Biotech Corp. (LEGN) PT Lowered to $56 at RBC Capital

Thu, 08 Oct 2026 08:27:29 -0400

RBC Capital analyst Leonid Timashev lowered the price target on Legend Biotech Corp. (NASDAQ: LEGN) to $56.00 (from $58.00) while maintaining a Outperform rating.

Form S-8 Legend Biotech Corp

Wed, 07 Oct 2026 16:16:00 -0400

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Form 4 Legend Biotech Corp For: Sep 29 Filed by: Sanders Corazon (Corsee) D.

Thu, 01 Oct 2026 16:04:00 -0400

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Legend Biotech launches ELITE grant program for multiple myeloma research

Thu, 01 Oct 2026 09:00:33 -0400

Legend Biotech Corporation (NASDAQ: LEGN) announced the launch of its Emerging Leadership & Innovation in Cell Therapy Excellence (ELITE) Program, an annual grant initiative aimed at early-career healthcare professionals conducting research, education, and innovation in multiple myeloma CAR-T cell therapy.

Applications for the inaugural program are open through November 20, 2026, with recipients to be notified in December 2026. Grant recipients will be invited to a recognition event in 2027 to present their proposals.

The program will award grants in two categories: the Emerging Educator: Excellence in CAR-T Award, supporting projects that advance clinical practice, research, healthcare delivery, or education in multiple

Legend Biotech Launches Inaugural ELITE Grant Program to Advance the Next Generation of CAR-T Innovation in Multiple Myeloma

Thu, 01 Oct 2026 09:00:00 -0400

Annual program will award funding to early-career healthcare professionals advancing research, education, and innovation in multiple myeloma

BRIDGEWATER, N.J., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced the launch of its inaugural Emerging Leadership & Innovation in Cell Therapy Excellence (ELITE) Program, an annual grant initiative designed to recognize and support early-career healthcare professionals advancing novel cell therapy approaches for the treatment of multiple myeloma. Applications are open through November 20, 2026.

“At Legend Biotech, we believe that advancing the future

Legend Biotech Launches Inaugural ELITE Grant Program to Advance the Next Generation of CAR-T Innovation in Multiple Myeloma

Thu, 01 Oct 2026 09:00:00 -0400

Annual program will award funding to early-career healthcare professionals advancing research, education, and innovation in multiple myeloma

“At Legend Biotech, we believe that advancing the future

H.C. Wainwright Reiterates Buy Rating on Legend Biotech Corp. (LEGN)

Wed, 30 Sep 2026 07:12:15 -0400

H.C. Wainwright analyst Mitchell S. Kapoor reiterated a Buy rating and $65.00 price target on Legend Biotech Corp. (NASDAQ: LEGN).

The analyst commented: "60.5-month median PFS and 69.2% five-year OS reinforce CARVYKTI’s durability edge in earlier-line multiple myeloma. Legend’s KOL call featured Dr. Marco Davila of Roswell Park and Dr. Leyla Shune, now in community practice at Franciscan St. Francis Health following 13 years at the University of Kansas. The discussion followed Legend’s IMS update from CARTITUDE-2 Cohort A, in which 10/20 patients remained alive and progression-free without additional anti-myeloma therapy ≥5 years after one infusion, at 60.7 months’ median follow-up.

Form 144 Legend Biotech Corp Filed by: Sanders Corazon (Corsee) D.

Tue, 29 Sep 2026 14:32:00 -0400

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Form 4 Legend Biotech Corp For: Sep 24 Filed by: Ji Darren Xiaohui