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Lyell Immunopharma reports developments tied to its next-generation chimeric antigen receptor, or CAR T-cell, therapy pipeline for patients with cancer. The company’s recurring updates center on ronde-cel, an autologous dual-targeting CD19/CD20 CAR T-cell product candidate for large B-cell lymphoma, and LYL273, a GCC-targeted CAR T-cell product candidate for metastatic colorectal cancer and other GCC-expressing cancers.
Company news also covers clinical-trial activity, FDA designation updates, manufacturing capabilities at the LyFE Manufacturing Center, quarterly financial results, equity financing activity, licensing transactions, investor-conference participation and executive or governance changes.
Lyell Immunopharma (LYEL) has completed the planned technology transfer of its GCC‑targeted CAR T candidate LYL273 to the LyFE Manufacturing Center in Bothell, Washington, following review by the U.S. Food and Drug Administration (FDA) of an improved manufacturing process and updated analytical methods.
LyFE is now implementing these changes to enhance manufacturing performance and increase capacity, and dosing of additional patients with product manufactured using the new process is ongoing in the Phase 1/2 trial in relapsed/refractory metastatic colorectal cancer. The trial, which targets patients in the third‑ or later‑line setting, continues enrollment with the goal of determining the recommended Phase 2 dose and an optimized safety management plan to support End‑of‑Phase 1 discussions with the FDA. Additional clinical data from this study and a planned End‑of‑Phase 1 FDA meeting are now expected in 2027, and the company reports strong investigator interest as it activates more clinical sites for the expansion phase.
Lyell Immunopharma (Nasdaq: LYEL) reported second quarter 2026 results and clinical progress in its CAR T-cell pipeline. The pivotal PiNACLE trial of ronde-cel in 3L+ LBCL remains on track, with additional data expected in 2H 2026, pivotal data in mid-2027 and a planned BLA submission in 2H 2027. Updated ronde-cel data in over 100 R/R LBCL patients showed no Grade ≥ 3 CRS, low Grade ≥ 3 ICANS and a 97% manufacturing success rate, supporting potential outpatient use.
For LYL273 in relapsed/refractory mCRC, adding GI prophylaxis reduced Grade ≥ 2 diarrhea or colitis from 55% to 10%, with no Grade ≥ 3 cases, enabling amendment of the U.S. study to a Phase 1/2 design that could support a pivotal single-arm Phase 2, subject to FDA discussions. Lyell reported Q2 2026 GAAP net loss of $44.8 million versus $42.7 million a year earlier, on revenue of $4 thousand, and ended June 30, 2026 with $228.0 million in cash, cash equivalents and marketable securities, which the company expects will fund operations into Q3 2027.
Lyell Immunopharma (Nasdaq: LYEL) announced that senior management will join a fireside chat at the H.C. Wainwright 4th Annual Cell Therapy Virtual Conference on June 30, 2026, at 1:30 p.m. ET.
A live webcast and replay will be available in the Investors section of Lyell’s website.
Lyell Immunopharma (Nasdaq: LYEL) reported updated safety and translational data for rondecabtagene autoleucel (ronde-cel) in relapsed/refractory large B-cell lymphoma at EHA 2026.
Among 108 treated patients, manufacturing success was 97%, no Grade ≥3 CRS was observed, ICANS rates were quantified, and translational analyses linked CD62L-enriched dual CD19/CD20 CAR T cells to durable responses. Pivotal PiNACLE data updates are expected in 2026–2027, with a potential BLA submission in 2H 2027.
Lyell Immunopharma (Nasdaq: LYEL) reported updated safety data for LYL273 in relapsed or refractory metastatic colorectal cancer and amended its U.S. Phase 1 trial to a Phase 1/2 design.
Gastrointestinal prophylaxis cut Grade ≥2 diarrhea/colitis from 55% (N=9) to 10% (N=10), with no Grade ≥3 CRS or ICANS observed in prophylaxis patients. Nineteen patients have been treated across Dose Levels 1–2, dose escalation continues, and the maximum tolerated dose is not yet defined. The amendment enables seamless expansion into a potential pivotal single-arm Phase 2, adds second-line and radiotherapy-combination cohorts, and targets up to ~84 patients across Phase 1 dose escalation and new cohorts. Additional Phase 1 data and an End-of-Phase 1 FDA meeting are anticipated in the second half of 2026.
Lyell Immunopharma (Nasdaq: LYEL) will present Phase 1/2 ronde-cel data in relapsed or refractory large B-cell lymphoma at the EHA 2026 Congress in Stockholm, June 11–14, 2026.
Two posters will cover updated safety (CRS, ICANS) and translational findings on durable responses and T-cell memory. Ronde-cel is also in two pivotal PiNACLE trials, with updated 3L+ data expected 2H 2026 and pivotal data by mid-2027, supporting a planned 2027 BLA submission.
Lyell Immunopharma (Nasdaq: LYEL) announced that senior management will participate in the Goldman Sachs 47th Annual Global Healthcare Conference 2026 on June 8, 2026, in Miami, Florida.
A fireside chat is scheduled for 11:20 a.m. ET, with a live webcast and replay available in the Investors section of Lyell’s website.
Lyell Immunopharma (Nasdaq: LYEL) announced that senior management will join two May 2026 investor events focused on oncology.
They will present at the H.C. Wainwright 4th Annual BioConnect Investor Conference/b) on May 19 and the on May 20, with live and replay webcasts on the investor website.
Lyell Immunopharma (Nasdaq: LYEL) reported Q1 2026 results and business updates on May 6, 2026. Key clinical milestones: PiNACLE pivotal trial additional data expected H2 2026, pivotal data mid-2027 with a BLA planned in 2027; PiNACLE-H2H Phase 3 dosing commenced; LYL273 dosing at Dose Level 3. Corporate: closed second $50M tranche at $25.61/share and held $261.0M cash as of March 31, 2026, which the company expects to fund operations into Q3 2027.
Lyell Immunopharma (Nasdaq: LYEL) said senior management will present at the 25th Annual Needham Virtual Healthcare Conference on April 14, 2026 at 11:00 AM ET. A live webcast will be available via the company investor website, with a replay posted after the presentation.
The presentation covers Lyell's late-stage CAR T-cell therapy pipeline and provides an opportunity for investor questions and management commentary.