Welcome to our dedicated page for Lyell Immunopharma news (Ticker: LYEL), a resource for investors and traders seeking the latest updates and insights on Lyell Immunopharma stock.
Lyell Immunopharma, Inc. (Nasdaq: LYEL) is a late-stage clinical company developing next-generation CAR T-cell therapies for cancer, and its news flow reflects the progress of these programs. Company announcements highlight clinical data from trials of rondecabtagene autoleucel (ronde‑cel, also referred to as LYL314) in relapsed and/or refractory large B-cell lymphoma (LBCL), including reported overall response rates, complete response rates, durability of responses, and safety findings from Phase 1/2 and pivotal studies.
News updates frequently cover milestones in Lyell’s pivotal development of ronde‑cel, such as the initiation and conduct of the single‑arm PiNACLE trial in the third‑ or later‑line setting and the Phase 3 PiNACLE – H2H head‑to‑head trial in the second‑line setting against approved CD19 CAR T-cell therapies. These releases often include details on trial design, patient populations, endpoints, and presentations at major scientific meetings like the American Society of Hematology (ASH) and the International Conference on Malignant Lymphoma.
For solid tumors, Lyell’s news also reports on LYL273, a GCC‑targeted CAR T-cell product candidate in Phase 1 development for refractory metastatic colorectal cancer. Disclosures include response rates, disease control rates, safety observations, and regulatory designations such as Fast Track status from the U.S. FDA. Additional corporate news items describe licensing transactions, equity financings, and operational updates that support the advancement of Lyell’s pipeline and manufacturing capabilities.
Investors and observers following LYEL news can use this page to review company-issued press releases on clinical trial readouts, regulatory designations, scientific conference presentations, licensing agreements, and capital raises related to Lyell’s CAR T-cell programs in hematologic malignancies and solid tumors.
Lyell Immunopharma (Nasdaq: LYEL) announced its participation in the H.C. Wainwright "HCW@Home" Series on June 25, 2025. The virtual fireside chat will feature CEO Lynn Seely and CFO Charlie Newton discussing their lead product LYL314, a dual-targeting CD19/CD20 CAR T-cell therapy for large B-cell lymphoma (LBCL).
The presentation will highlight recent positive clinical data presented at ICML and focus on next-generation CAR T-cell therapies. LYL314, which has received both RMAT and Fast Track designations from the FDA, aims to improve complete response rates and response duration compared to existing CD19-targeted therapies.
Lyell Immunopharma (LYEL) has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for its LYL314 therapy, targeting relapsed/refractory large B-cell lymphoma. The designation was based on promising data from an ongoing Phase 1/2 trial.
Key clinical results include:
- 94% overall response rate (16/17 patients)
- 71% complete response rate (12/17 patients)
- 71% of patients maintaining response at last follow-up
- Median follow-up of 6.3 months
- No Grade 3+ cytokine release syndrome reported
LYL314 is a dual-targeting CD19/CD20 CAR T-cell therapy designed to improve complete response rates compared to existing treatments. The company plans to initiate two pivotal programs: one in mid-2025 for 3rd+ line treatment and another in early 2026 for 2nd line treatment. Additional clinical updates are expected throughout 2025.
Lyell Immunopharma (LYEL) reported its Q4 and full-year 2024 results, highlighting significant developments in its CAR T-cell therapy pipeline. The company's lead program, IMPT-314, showed promising Phase 1 data with a 94% overall response rate and 71% complete response rate in large B-cell lymphoma patients.
Key financial metrics include a net loss of $191.9M for Q4 and $343.0M for full-year 2024. Cash position stands at $383.5 million, expected to fund operations into 2027. The company plans to initiate pivotal trials for IMPT-314 in mid-2025 for 3rd line treatment and early 2026 for 2nd line treatment.
Research and development expenses were $48.7M in Q4 and $171.6M for the full year. The company acquired ImmPACT Bio, incurring $87.2M in IPR&D expenses, and recorded a $51.3M impairment charge on long-lived assets due to stock price decline.
Lyell Immunopharma (Nasdaq: LYEL), a clinical-stage company focused on developing next-generation CAR T-cell therapies for cancer patients, has announced its participation in two upcoming investor conferences. The company's senior management team will present at:
- The H.C. Wainwright 3rd Annual Cell Therapy Virtual Conference on February 25th at 2:30 pm Eastern Time
- The TD Cowen's 45th Annual Health Care Conference on March 3rd at 11:50 am Eastern Time
Interested parties can access live webcasts of the presentations through the Investors section of Lyell's website (www.lyell.com). Replay options will be available on the company's website following the live presentations.
Lyell Immunopharma (LYEL) announced significant pipeline updates focusing on IMPT-314, their dual-targeting CD19/CD20 CAR T-cell therapy for large B-cell lymphoma. The company plans to initiate pivotal trials in both 3rd line+ setting (mid-2025) and 2nd line setting (early 2026). Initial clinical data showed promising results with a 94% overall response rate and 71% complete response rate in 3rd-line+ patients.
To optimize resources, Lyell is discontinuing development of LYL119 (ROR1-targeting CAR T-cell product) and IMPT-514 (autoimmune disease program) to focus on IMPT-314 and early-stage solid tumor programs. The company projects net cash use of $175-185 million for 2025, extending their cash runway into 2027. Additional clinical data from ongoing trials will be presented in mid-2025, including mature data from 3rd line+ cohort and initial 2nd line data.