Lyell Immunopharma, Inc. (LYEL)

SOUTH SAN FRANCISCO, Calif., Dec. 07, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced new clinical and translational data from the ongoing clinical trial of rondecabtagene autoleucel (ronde-cel, also known as LYL314) in patients with large B-cell lymphoma (LBCL), which were presented today in two oral presentations at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition. As of the data cutoff date of September 5, 2025, ronde-cel continued to demonstrate robust clinical responses with a manageable safety profile appropriate for outpatient administration. A 93% overall response rate, a 76% complete response rate, and median progression-free survival of 18 months were reported for patients with relapsed and/or refractory (R/R) LBCL in the third- or later-line (3L+) setting. Patients evaluated in the second-line (2L) setting (94% with difficult-to-treat primary refractory disease) achieved an 83% overall response rate and a 61% complete response rate, and 70% of patients with a complete response remained in complete response at 6 months or longer.

Lyell Immunopharma, Inc. (NASDAQ: LYEL - Get Free Report)'s share price reached a new 52-week high on Friday. The company traded as high as $25.59 and last traded at $25.46, with a volume of 93527 shares. The stock had previously closed at $22.31. Wall Street Analyst Weigh In Several analysts have issued reports on the

Acquired exclusive global rights to LYL273, a novel GCC-targeted CAR T-cell product candidate that has demonstrated a 67% overall response rate, an 83% disease control rate and a manageable safety profile at the highest dose level studied to date in patients with refractory metastatic colorectal cancer in an ongoing U.S. Phase 1 clinical trial Received RMAT designation from the U.S. FDA for ronde-cel for the treatment of patients with relapsed or refractory LBCL receiving treatment in the second-line (2L) setting Announced that two abstracts highlighting new clinical and translational data from the Phase 1/2 clinical trial of ronde‑cel for the treatment of aggressive large B-cell lymphoma have been accepted for oral presentation at the ASH 67th Annual Meeting and Exposition in December Announced the initiation of PiNACLE - H2H, a Phase 3 head-to-head CAR T-cell therapy clinical trial in aggressive large B-cell lymphoma in the 2L setting Formed a PiNACLE – H2H Steering Committee comprised of a distinguished group of lymphoma and cell therapy experts Cash of approximately $320 million at the end of the third quarter of 2025; current cash is expected to support advancing pipeline into 2027 through key clinical milestones SOUTH SAN FRANCISCO, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today reported financial results and business highlights for the third quarter ended September 30, 2025.

LYL273 has demonstrated a 67% overall response rate, an 83% disease control rate, and a manageable safety profile at the highest dose level studied to date in patients with refractory metastatic colorectal cancer enrolled in an ongoing U.S. Phase 1 clinical trial LYL273 is a GCC-targeted CAR T-cell product candidate armed with enhancements designed to improve CAR T-cell expansion and cancer cell killing Lyell management will host an investor webcast at 8:30 AM ET today SOUTH SAN FRANCISCO, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced it has strengthened its solid tumor pipeline by acquiring global rights to LYL273 (formerly GCC19CART), a novel autologous guanylyl cyclase-C (GCC)-targeted CAR T-cell product candidate for the treatment of metastatic colorectal cancer (mCRC) and other GCC-expressing cancers, from Innovative Cellular Therapeutics (ICT).

SOUTH SAN FRANCISCO, Calif., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, today announced that two abstracts highlighting new clinical and translational data from the Phase 1/2 clinical trial of rondecabtagene autoleucel (ronde-cel, also known as LYL314) for the treatment of aggressive large B-cell lymphoma (LBCL) will be presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.

PiNACLE - H2H will evaluate rondecabtagene autoleucel (ronde-cel) versus investigator's choice of approved CD19 CAR T-cell therapies in patients with aggressive large B-cell lymphoma receiving treatment in the second line (2L) setting Ronde-cel is Lyell's next-generation, dual-targeting CD19/CD20 CAR T-cell therapy designed to deliver improved complete response rates and longer duration of responses over currently approved CD19 CAR T-cell therapies Steering Committee of distinguished lymphoma experts established to advise on the design and conduct of this first-of-its-kind CAR T-cell clinical trial SOUTH SAN FRANCISCO, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation CAR T-cell therapies for patients with cancer, today announced the initiation of PiNACLE - H2H, a Phase 3 head-to-head CAR T-cell therapy randomized controlled trial and the formation of a Steering Committee of preeminent lymphoma experts.

SOUTH SAN FRANCISCO, Calif., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation CAR T-cell therapies for patients with cancer, announced today that members of its senior management team will present and participate in the following investor conferences: Morgan Stanley 23rd Annual Global Healthcare Conference on Monday, September 8th at 9:15 am Eastern Time H.C.

SOUTH SAN FRANCISCO, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation CAR T-cell therapies for patients with cancer, today reported financial results and business highlights for the second quarter ended June 30, 2025. Lyell's lead clinical program, LYL314, is a next-generation autologous dual-targeting CD19/CD20 CAR T-cell product candidate under evaluation in PiNACLE, a single-arm pivotal trial enrolling patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) in the 3L+ setting and in a Phase 1/2 study in the 2L setting.

SOUTH SAN FRANCISCO, Calif., July 25, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing next-generation CAR T-cell therapies for patients with cancer, today announced that it has entered into a securities purchase agreement for a private placement with certain institutional and other accredited investors, for gross proceeds of up to approximately $100 million.

Lyell Immunopharma's LYL314 CAR-T therapy shows high, durable response rates in 3rd-line + Large B-Cell Lymphoma patients. The company has initiated a phase 3 trial for LYL314 in 3rd-line + LBCL following positive FDA feedback after the end-of-phase 1 meeting. A key upcoming catalyst is the planned phase 3 trial in 2nd-line + LBCL patients, expected to begin in early 2026.

SOUTH SAN FRANCISCO, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing next-generation CAR T-cell therapies for patients with cancer, announced today that members of its senior management team will participate in the H.C. Wainwright “HCW@Home” Series taking place virtually on Wednesday, June 25, 2025, at 12:00 PM ET.

SOUTH SAN FRANCISCO, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing next-generation CAR T-cell therapies for patients with cancer, today announced positive new clinical data from the multi-center Phase 1/2 trial of LYL314, including data from patients with large B-cell lymphoma (LBCL) treated in the third- or later-line (3L+) setting. LYL314 is an autologous dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate with Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA that is in development for patients with relapsed and/or refractory (R/R) LBCL. In patients treated in the 3L+ setting (N = 25), LYL314 continued to demonstrate robust clinical responses, with an 88% overall response rate and a 72% complete response rate. Of the 3L+ patients who achieved a complete response, 71% remained in complete response at ≥ 6 months. The single-arm pivotal PiNACLE trial, a seamless expansion of the Phase 1/2 trial of patients with R/R LBCL being treated in the 3L+ setting, is underway.

SOUTH SAN FRANCISCO, Calif., June 09, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, today announced the appointment of Mark J. Bachleda, PharmD, MBA as an independent member of the Board of Directors, David Shook, MD as Chief Medical Officer, and Mark Meltz, JD as General Counsel and Corporate Secretary. These appointments, along with the appointment earlier in the year of Jarrad Aguirre, MD, MBA as Senior Vice President, Medical Affairs, further strengthen the Company's clinical and commercial capabilities.

SOUTH SAN FRANCISCO, Calif., June 04, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, announced today that members of its senior management team will present and participate in the Goldman Sachs 46th Annual Global Healthcare Conference on Wednesday, June 11th at 10:00 am ET.

SOUTH SAN FRANCISCO, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, today reported financial results and business highlights for the first quarter ended March 31, 2025. Lyell's lead clinical program, LYL314 (formerly known as IMPT-314), is an autologous CD19/CD20 dual-targeting CAR T-cell product candidate under evaluation in a Phase 1/2 trial enrolling patients with relapsed and/or refractory large B-cell lymphoma (LBCL). LYL314 was recently granted RMAT designation by the United States FDA in recognition of its potential to address significant unmet needs in patients with aggressive LBCL in the third- or later-line setting.

SOUTH SAN FRANCISCO, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, today announced that an abstract highlighting new clinical data from the Phase 1/2 trial of LYL314 (formerly IMPT-314) in large B-cell lymphoma will be presented as an oral presentation at the International Conference on Malignant Lymphoma (ICML) 2025 taking place in Lugano, Switzerland June 17-21, 2025.